[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prostate-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prostate-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,783,0,25,[9,42,87,115,139,174,197,223,244,270,283,293,326,346,371,393,416,444,482,509,518,541,575,614,623],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100054324","phase-3-a-clinical-study-of-ifinatamab-deruxtecan-i-dxd-in-people-with-metastatic-prostate-cancer-mk-2400-001-100054324",false,"NCT06925737","A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)","A Phase 3, Open-label Study of Ifinatamab Deruxtecan Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (IDeate-Prostate01)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology\n* Has prostate cancer progression while on androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months prior to Screening\n* Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and\u002For soft tissue disease by computed tomography (CT)\u002Fmagnetic resonance imaging (MRI)\n* Has received prior treatment with 1 or 2 androgen receptor pathway inhibitors (ARPIs) and progressed during or after at least 8 weeks of treatment\n* Has provided tumor tissue from a core or excisional biopsy from soft tissue not previously irradiated and obtained after disease progression on the most recent prior therapy\n* Has recovered from adverse events (AEs) due to previous anticancer therapies\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Is unable to swallow tablets\u002Fcapsules\n* Has any of the following indicators of interstitial lung disease (ILD)\u002Fpneumonitis:\n\n  1. Has any history of ILD\u002Fpneumonitis that required steroid use, except for a history of radiation pneumonitis that did not require steroids\n  2. Has current ILD\u002Fpneumonitis\n  3. Has a clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out\n* Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses\n* Has uncontrolled or significant cardiovascular disease\n* Has received prior treatment with a taxane-based chemotherapy agent for metastatic castration-resistant prostate cancer (mCRPC)\n* Has had prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities\n* Has a \"superscan\" bone scan","MALE","18 Years",{"count":20,"type":21},1440,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","Researchers are looking for new ways to treat metastatic castration-resistant prostate cancer (mCRPC). Researchers have designed a study medicine called ifinatamab deruxtecan (also called I-DXd or MK-2400) to treat mCRPC. The goal of this study is to learn if people who receive I-DXd live longer overall and live longer without the cancer growing or spreading than people who receive chemotherapy.",[27,28],"Prostate Cancer","Prostatic Neoplasms","RECRUITING","2026-07-10",{"date":32,"type":33},"2026-07-13","ACTUAL",{"date":35,"type":33},"2025-05-13",{"date":37,"type":21},"2031-01-06",{"name":39,"class":40},"Merck Sharp & Dohme LLC","INDUSTRY",290,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":12,"sex":48,"minAge":18,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":55,"conditions":56,"keywords":65,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":78,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":86},"100053405","phase-1-atezolizumab-plus-tivozanib-in-immunologically-cold-tumor-types-100053405","NCT05000294","Atezolizumab Plus Tivozanib in Immunologically Cold Tumor Types","Inclusion Criteria:\n\n* Subjects must have had at least one prior treatment with systemic therapy for advanced and unresectable, or metastatic disease OR is intolerant to, has refused or for whom there are no standard therapies that impart significant clinical benefit in the opinion of the treating investigator.\n* An Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 1 for phase 1B. An ECOG Performance Status less than or equal to 2 for phase 2.\n* Subjects must not have more than one malignancy at the time of enrollment\n* Adult subjects ≥ eighteen years of age\n* A clinical diagnosis consistent with stage IV \"immunogenically cold\" or otherwise incurable cancer of one of the following histologies: i) bile duct or gallbladder cancer ii) Metastatic breast cancer, HR-negative HER2-positive, who have received at least 3 lines of therapy for disease progression that includes: trastuzumab, pertuzumab\u002Ftrastuzumab, and ado-trastuzumab emtansine iii) neuroendocrine cancer with the following pathological characteristics: grade 2 or 3; well- or moderately- differentiated (Grades 1, 4, and poorly differentiated neuroendocrine pathologies are not eligible) iv) FIGO stage IV or metastatic (using 2021 FIGO classification) high grade serious or high grade endometrioid (based on local histopathological findings) ovarian cancer, primary peritoneal cancer and \u002F or fallopian-tube cancer that is platinum resistant, with no acceptable standard of care v) pancreatic adenocarcinoma vi) soft tissue sarcoma vii) prostate cancer subjects who are castrate-resistant (testosterone ≤ 50 ng\u002FdL) and have progressed on, declined, or are intolerant to other standard of care therapies. Subjects with prostate cancer must have failed at least one line of treatment with an androgen inhibitor (AI) (i.e. enzalutamide, abiraterone, etc.) or cytotoxic chemotherapy in the advanced or metastatic setting viii) vulvar cancer\n* Adequate hematologic and end-organ function\n* Subjects receiving therapeutic anticoagulation must be on a stable anticoagulant regimen for ≥ 2 weeks at start of protocol treatment\n* Negative hepatitis B surface antigen (HBsAg) test at screening\n* Negative HIV test at screening with the following exceptions: subjects with a positive HIV test at screening are eligible only if they meet the following three conditions: 1) Are stable on anti-retroviral therapy 2) Have a CD4 count ≥ 200\u002FuL AND 3) Have an undetectable viral load.\n* Women of childbearing potential (WOCBP) must be using an adequate method of contraception (with a failure rate of \\\u003C1% per year) to avoid pregnancy throughout the study and for at least 160 days after the last dose of either study drug to minimize the risk of pregnancy.\n* Males with female partners of child-bearing potential must agree to use physician-approved contraceptive methods throughout the study and should avoid conceiving children for 160 days following the last dose of study drug.\n* Measurable disease by RECIST criteria\n* A life expectancy of ≥ 12 weeks\n* Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures\n* Must have formalin-fixed paraffin embedded (FFPE) tissue or 12 unstained slides available for research purposes. Tissue must have been obtained within the last 3 years.\n* If a new biopsy is needed for diagnostic reasons, the biopsy must be performed from a tumor site that is not the only site of measurable disease\n* Subject must be able to swallow capsules\n\nExclusion Criteria:\n\n* Subjects with known MSI-H or dMMR tumor status\n* Subjects with severe uncontrolled hypertension as defined as systolic blood pressure \\> 150 mmHg or diastolic blood pressure \\> 100 mmHg\n* Subjects who have had prior treatment with vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors\n* Females or males of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 160 days after the last dose of study drug\n* Females who are pregnant or breastfeeding\n* History of leptomeningeal disease\n* Uncontrolled or symptomatic hypercalcemia (ionized calcium \\> 1.5 mmol\u002FL, calcium \\> 12 mg\u002FdL or corrected serum calcium \\> ULN)\n* Uncontrolled tumor-related pain\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently, except in the case of ovarian cancer with ascites, which may require more frequent drainage). Subjects with indwelling catheters are allowed.\n* Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions:\n\n  1. subjects with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.\n  2. subjects with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n  3. subjects with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., subjects with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n\n     * Rash must cover \\\u003C10% of body surface area\n     * Disease is well controlled at baseline and requires only lowpotency topical corticosteroids\n     * There has been no occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n* Active tuberculosis\n* Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina\n* Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study\n* History of malignancy other than the malignancies listed in the inclusion criteria of enrollment within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \\> 90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer\n* Severe infection within 4 weeks prior to initiation of study treatment including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that could impact patient safety\n* Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment. Note: Subjects receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.\n* Prior allogeneic stem cell or solid organ transplantation\n* Current treatment with anti-viral therapy for hepatitis B virus (HBV)\n* Treatment with investigational therapy within 28 days prior to initiation of study treatment\n* Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies\n* Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment\n* Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:\n\n  1. Subjects who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study.\n  2. Subjects who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study.\n* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n* Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation\n* History of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician\n* Administration of a vaccine containing live virus within 30 days prior to the first dose of trial treatment, during treatment with atezolizumab, and for 160 days after the last dose of atezolizumab. Note: Most flu vaccines are killed viruses, with the exception of the intra-nasal vainer (Flu-Mist) which is an attenuated live virus and therefore prohibited for 30 days prior to first dose. Subjects may receive non-live COVID-19 vaccine.\n* Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.\n* Subjects with Tumor Mutation Burden (TMB) ≥10\n* Treatment with any cancer directed therapy (i.e. chemotherapy, radiation therapy, Y90, microwave ablation, immunotherapy, etc.) within 28 days of study start\n* Subjects with treated brain metastases that have remained stable for at least 90 days without steroids are allowed. Subjects with signs of symptoms or history of brain metastasis must have a CT or MRI of the brain within 30 days prior to the start of protocol therapy.\n* Subjects with autoimmune diseases requiring current treatment and subjects with history of severe autoimmune diseases, subjects with hypothyroidism, adrenal insufficiency, or pituitary insufficiency who are stable on therapy are allowed.\n* Inability to discontinue use of medications contraindicated by the study treatment\n* Proteinuria \\> 2.5 g\u002F24 hours or 3+ with urine dipstick\n* QTc interval \\> 470 at screening or known cardiovascular disease defined as (a) a clinically significant abnormal ECG at screening, or (b) myocardial infarction within 12 weeks prior to start of protocol therapy","ALL","99 Years",{"count":51,"type":21},29,[53,54],"PHASE1","PHASE2","Checkpoint inhibitor therapy represents a significant advance in cancer care. The interaction between PD-1 and PD-L1 induces immune tolerance, and the inhibition of this interaction is an effective treatment strategy for numerous malignancies.\n\nDespite its demonstrated potential, immunotherapy is not currently thought to be an effective intervention in the treatment of several immunologically \"cold\" tumors such as prostate cancer, biliary tract cancers, soft tissue sarcomas, well-differentiated neuroendocrine tumors, microsatellite stable colorectal cancer, pancreatic cancer, and non-triple negative breast cancer.\n\nVascular endothelial growth factor (VEGF) is thought to play a key role in modulating the anti-tumor immune response. Vascular endothelial growth factor (VEGF) is secreted by tumors and leads to endothelial cell proliferation, vascular permeability, and vasodilation. This in turn leads to the development of an abnormal vasculature with excessive permeability and poor blood flow, limiting immune surveillance. In addition, VEGF inhibits dendritic cell differentiation, limiting the presentation of tumor antigens to CD4 and CD8 T cells. Vascular endothelial growth factor (VEGF). VEGF tyrosine kinase inhibitors (TKIs) VEGF-TKIs are currently utilized in the treatment of a variety of malignancies and are widely utilized in combination with checkpoint blockade in the treatment of clear cell kidney cancer.\n\nThrough the inhibition of VEGF, it may be possible to potentiate the effect of immune checkpoint blockade even in tumors which have traditionally been thought to be unresponsive to immunotherapy. This study aims to evaluate the combination of the immune checkpoint inhibitor atezolizumab and the VEGF-TKI tivozanib in a variety of tumors which have a low response rate to checkpoint inhibitor therapy alone.",[57,58,59,60,61,62,63,64,27],"Bile Duct Cancer","Gall Bladder Cancer","Breast Cancer","Neuroendocrine Tumors","Ovarian Cancer","Pancreatic Adenocarcinoma","Soft Tissue Sarcoma","Vulvar Cancer",[66,67,68,69,70,71,72,73,74,75,76,77],"immunologically cold tumors","breast cancer","bile duct cancer","gallbladder cancer","neuroendocrine cancer","ovarian cancer","pancreatic adenocarcinoma","soft tissue sarcoma","prostate cancer","vulvar cancer","TKI","checkpoint inhibitor",{"date":32,"type":33},{"date":80,"type":33},"2021-12-07",{"date":82,"type":21},"2027-06",{"name":84,"class":85},"University of Florida","OTHER",1,{"id":88,"slug":89,"hasResults":12,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":94,"enrollmentInfo":95,"targetDuration":4,"studyType":22,"phases":97,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":107,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":86},"100053341","phase-2-il-15-superagonist-with-or-without-vaccine-in-biochemically-recurrent-prostate-cancer-after-previous-stereotactic-body-radiation-therapy-100053341","NCT07686380","IL-15 Superagonist With or Without Vaccine in Biochemically Recurrent Prostate Cancer After Previous Stereotactic Body Radiation Therapy","Phase II Trial of IL-15 Superagonist With or Without Vaccine in Biochemically Recurrent Prostate Cancer After Previous Stereotactic Body Radiation Therapy","* INCLUSION CRITERIA:\n* Histopathological confirmation of prostate adenocarcinoma by the Laboratory of Pathology at the National Institutes of Health (NIH) Clinical Center prior to the study treatment initiation. If no pathologic specimen is available, participants may enroll with a pathologist s report showing a histologic diagnosis of prostate adenocarcinoma and a clinical course consistent with the disease from any outside site.\n* Biochemically recurrent prostate cancer, defined as PSA over 0.8 ng\u002Fml following radical prostatectomy or \\>= 2 ng\u002Fml above the nadir following definitive radiotherapy or definitive radiotherapy (including brachytherapy) for localized prostate cancer.\n* Participants must be at least 1 year removed from definitive local therapy before the study treatment initiation.\n* Recovery to baseline from acute toxicity related to prior therapy, including surgery and radiation.\n* Hepatic function eligibility parameters: Bilirubin (total and direct) \\\u003C= upper limit of normal (ULN) (OR in participants with Gilbert s syndrome, a total bilirubin \\\u003C= 3.0), aspartate transaminase (AST) and alanine transaminase (ALT) \\\u003C= 1.5 times upper limit of normal.\n* Adequate renal function defined by a calculated creatinine clearance \\> 50 mL\u002Fmin according to the Cockcroft-Gault formula or by measure of creatinine clearance from 24-hour urine collection.\n* ECOG performance score 0-1.\n* No other active malignancies within the 36 months prior to the study treatment initiation (with the exception of nonmelanoma skin cancers or carcinoma in situ of the bladder).\n* 18 years of age or older.\n* Individuals must agree to use effective contraception (barrier, vasectomy and\u002For abstinence) for the duration of study therapy and for four months after the last treatment administration. Individuals with partners with birthing potential will be recommended that their partner use a highly effective contraception (includes use of oral, injected or implanted hormonal methods of contraception, placement of certain intrauterine devices (IUD) or intrauterine systems (IUS), hysterectomy, oophorectomy, salpingectomy.\n* Individuals must agree to not donate sperm during the restricted period (for the duration of study therapy and for four months after the last dose of study treatment).\n* Negative CT scan\u002F Magnetic resonance imaging (MRI) for evidence of soft tissue metastasis (visceral or lymph node).\n* Negative Tc99 for evidence of bone disease.\n* Participants must have had prior SBRT to PSMA+ findings beyond the prostate and have had a documented 25% or more PSA rise from post-SBRT nadir\n* Baseline testosterone \\>= 100 ng\u002Fdl.\n* Hematological parameters:\n\n  * Granulocyte count \\>= 1000\u002Fmm\\^3\n  * Platelet count \\>= 100000\u002Fmm\\^3\n  * Hemoglobin (Hgb) \\>= 10 g\u002FdL\n* Participants must be able to understand and willing to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Immunocompromised status due to:\n\n  * Human immunodeficiency virus (HIV) seropositivity\n  * HBV or HCV seropositivity\n  * Other immunodeficiency diseases\n* Active autoimmune diseases such as Addison's disease, Hashimoto's thyroiditis, systemic lupus erythematosus, Sjogren syndrome, scleroderma, myasthenia gravis, Goodpasture syndrome or active Grave's disease. Participants with a history of autoimmunity that has not required systemic immunosuppressive therapy or does not threaten vital organ function including central nervous system (CNS), heart, lungs, kidneys, skin, and gastrointestinal (GI) tract will be allowed. Participants with diabetes type I, vitiligo, or alopecia are allowed.\n* Receipt of any organ transplantation, including allogeneic stem-cell transplantation, but with the exception of transplants that do not require immunosuppression (e.g., corneal transplant, hair transplant).\n* Chronic administration (defined as daily or every other day for continued use \\> 14 days) of systemic corticosteroids within 28 days before the study treatment initiation. Note: Use of corticosteroids with minimal systemic absorption (e.g., inhaled steroids, nasal sprays, and topical agents) is allowed.\n* Other medications used for urinary symptoms including 5-alpha reductase inhibitors (finasteride and dutasteride) and alternative medications known to alter PSA (e.g., phytoestrogens and saw palmetto) within 28 days prior to the study treatment initiation.\n* Major surgery within 28 days prior to study treatment initiation.\n* Systemic therapy, including any investigational therapy within 28 days prior to the study treatment initiation.\n* Radiation therapy within 14 days prior to the study treatment initiation.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drugs.\n* Clinically significant cardiovascular\u002Fcerebrovascular disease as follows: cerebral vascular accident\u002Fstroke (\\\u003C 6 months prior to the first planned dose of study drugs), myocardial infarction (\\\u003C 6 months prior to the first planned dose of study drugs), or any of the following at time of enrollment: unstable angina, congestive heart failure (New York Heart Association Classification Class \\>= II), serious cardiac arrhythmia, or uncontrolled hypertension (SBP\\>170\u002F DBP\\>105).\n* Serious intercurrent medical illness evaluated by medical history and physical exam that would interfere with participant's ability to carry out the treatment program.","120 Years",{"count":96,"type":21},65,[54],"Background:\n\nBiochemically recurrent prostate cancer (BCR) occurs when prostate-specific antigen (PSA) levels in the blood rise after surgery or radiation. BCR affects 30,000 to 50,000 men each year. Researchers want to know if a drug (N-803) alone or combined with a vaccine (ETBX-071) can reduce PSA in BCR prostate cancer after radiation.\n\nObjective:\n\nTo test a study drug alone and combined with a vaccine in people with BCR prostate cancer who have been treated with targeted radiation to areas of recurrent prostate cancer in the past.\n\nEligibility:\n\nPeople aged 18 years and older with BCR prostate cancer who have previously undergone treatment with stereotactic body radiation therapy (SBRT).\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood tests. They will have tests of their heart and kidney function. They will have 3 different imaging scans of their tumors.\n\nN-803 is injected under the skin of the abdomen. ETBX-071 is injected under the skin of thigh.\n\nParticipants will be divided into 2 groups: 1 group will get N-803 alone; 1 group will get both N-803 and ETBX-071.\n\nThe drug or drugs will be given on the first day of 21-day treatment cycles. Participants will have 8 treatment cycles.\n\nParticipants will have a follow-up visit 3 weeks after their last dose of the study drugs. Blood tests and all 3 imaging scans will be repeated.\n\nFollow-up visits will continue every 4 to 8 weeks for 5 years. These visits will include a positron emission tomography (PET) scan every 6 months.",[100,27],"Recurrent Prostate Cancer",[100,102,103,104,105],"IL-15 Superagonist","N-803","ETBX-071","PSA Vaccine","NOT_YET_RECRUITING",{"date":32,"type":33},{"date":109,"type":21},"2026-07-16",{"date":111,"type":21},"2029-01-30",{"name":113,"class":114},"National Cancer Institute (NCI)","NIH",{"id":116,"slug":117,"hasResults":12,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":94,"enrollmentInfo":122,"targetDuration":4,"studyType":22,"phases":124,"briefSummary":125,"conditions":126,"keywords":132,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":134,"startDateStruct":135,"completionDateStruct":136,"leadSponsor":138,"locationsCount":86},"100053608","phase-2-multitargeted-recombinant-ad5-psamuc-1brachyury-based-immunotherapy-triadeno-vaccine-with-il-15-superagonist-n-803-in-participants-with-clinically-localized-prostate-cancer-undergoing-active-surveillance-100053608","NCT07574541","Multitargeted Recombinant Ad5 PSA\u002FMUC-1\u002FBrachyury-Based Immunotherapy (TriAdeno) Vaccine With IL-15 Superagonist N-803 in Participants With Clinically Localized Prostate Cancer Undergoing Active Surveillance","Phase II Trial of a Multitargeted Recombinant Ad5 PSA\u002FMUC-1\u002FBrachyury-based Immunotherapy (TriAdeno) Vaccine With IL-15 Superagonist N-803 in Participants With Clinically Localized Prostate Cancer Undergoing Active Surveillance","* INCLUSION CRITERIA:\n* Histologically confirmed diagnosis of organ confined, low- or intermediate-risk PCa (Gleason grade group 1 or 2) identified in at least one prostate biopsy core. Biopsies performed at outside institutions should have Gleason score confirmed at the NCI by a genitourinary (GU) pathologist.\n* Participants must be on active surveillance.\n* Pre-study treatment tissue availability (at least one formalin-fixed paraffin embedded \\[FFPE\\] biopsy core or one H and E-stained slide and at least 5 unstained slides) obtained between 3 and 24 months prior to treatment initiation is mandatory for study initiation.\n* Serum PSA level of \\\u003C20 ng\u002FmL (or \\\u003C10ng\u002FmL for participants being treated with 5- alpha-reductase inhibitors)\n* Clinical stage \\\u003C=T2a by digital rectal exam (DRE)\n* Age \\>=18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status \\\u003C=1.\n* Adequate organ and marrow function as defined below:\n\n  * Absolute neutrophil count (ANC) \\>=1.0 x 109\u002FL\n  * Hemoglobin (Hgb) \\>=9 g\u002FdL\n  * Platelets \\>=75,000\u002FmcL\n  * Prothrombin International Normalized Ratio (INR) \\\u003C1.5 x upper limit of normal (ULN)\n  * Partial thromboplastin time (PTT) \\\u003C1.5 x ULN\n  * Total bilirubin \\\u003C1.5 x ULN\n  * Aspartate aminotransferase (AST) \\\u003C=2.5 x ULN\n  * Alanine aminotransferase (ALT) \\\u003C=2.5 x ULN\n  * Creatinine \\\u003C=1.5 x ULN\n\nOR\n\n--Calculated Creatinine clearance \\>=40 mL\u002Fmin\u002F1.73 m2 for individuals with creatinine levels above institutional normal (using either Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\] equation)\n\n* Treatment with steroid therapy must have a washout of at least 6 weeks prior to initiation of study treatment. Physiologic (replacement) doses of steroids as well as nasal, topical, or inhaled steroids are allowed.\n* Vaccination with a live (attenuated) vaccine (e.g., FluMist(R)) or a killed (inactivated)\u002Fsubunit vaccine (e.g., PNEUMOVAX(R), Fluzone(R)) must occur not sooner than 28 days or 14 days, respectively, prior to initiation of study treatment.\n* Participants must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of the study treatment and up to one (1) month after the last vaccine injection. We also will recommend participants with female partners of childbearing potential to ask them to be on highly effective birth control (hormonal, intrauterine device \\[IUD\\], surgical sterilization). Participants must not freeze or donate sperm within the same period.\n* Participants must be able to understand and willing to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Prior treatment for PCa by surgery, radiation, local ablative (i.e., cryosurgery or highintensity focused ultrasound), or androgen-deprivation therapy.\n* Evidence of PCa with metastatic disease.\n* Prior treatment with adenovirus-based vector immunotherapy, adenovirus-based vaccines, or investigational vaccines.\n* Prior solid organ or bone marrow transplant.\n* Immunodeficiency or splenectomy.\n* Presence of a known active acute or chronic infection, including human immunodeficiency virus (HIV), confirmed by PCR, and hepatitis B virus (HBV) and hepatitis C virus (HCV), as determined by hepatitis B surface antigen (HBsAg) and HCV serology.\n* History of autoimmune disease (active or past), except for autoimmune-related thyroid disease, type I diabetes, and vitiligo if the condition(s) is well controlled.\n* History of heart disease, such as congestive heart failure (class II, III, or IV defined by the New York Heart Association functional classification), history of unstable or poorly\n\ncontrolled angina, or history (\\\u003C1 year prior to initiation of study therapy) of ventricular arrhythmia.\n\n* Acute or chronic skin disorders that will interfere with injection into the skin of the extremities or subsequent assessment of potential skin reactions.\n* Second malignancy within 3 years prior to initiation of study therapy. Note: Individuals with curatively treated non-melanoma skin cancers or non-muscle invasive bladder cancer will not be excluded.\n* History of herbal products that may decrease PSA levels (e.g., saw palmetto).\n* Participants who have undergone surgery within 4 weeks prior to initiation of study therapy.\n* Participants receiving any other investigational agents within 30 days prior to initiation of study therapy.\n* History of allergic reaction attributed to compounds of similar chemical or biological composition to the study drugs.\n* Uncontrolled intercurrent illness that would limit compliance with study requirements suggested by medical history, physical examination, or standard clinical assessments such as imaging, EKG, and laboratory studies.",{"count":123,"type":21},52,[54],"Background:\n\nProstate cancer is the second most common cause of cancer-related death among men in the United States. Early-stage, low-grade prostate cancer is managed with active monitoring. However, 35% of men with this cancer will need treatment within 5 years because of tumor growth. Researchers want to know if a new vaccine that targets 3 anti-cancer proteins (TriAdeno) plus a drug (N-803) approved for bladder cancer can help stop prostate tumors from growing.\n\nObjective:\n\nTo test TriAdeno and N-803 in people with early-stage prostate cancer.\n\nEligibility:\n\nPeople aged 18 years and older with early-stage low- or medium-risk prostate cancer.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood tests. They will have a test of their heart function. They will have an imaging scan. They may have a rectal exam.\n\nTriAdeno is injected under the skin of the upper thigh; N-803 is injected under the skin of the abdomen. Participants will be treated in up to four 21-day cycles. They will get both injections on the first day of each cycle.\n\nParticipants may opt to complete a memory aid: They may record all of their symptoms for 7 days after each injection. They may also complete a questionnaire about their prostate symptoms.\n\nBlood tests, imaging scans, and other tests will be repeated during the study.\n\nA tissue sample (biopsy) of the tumor will be collected during or after cycle 2; a second biopsy may be taken about 1 year later.\n\nParticipants will have follow-up phone calls for 5 years....",[127,27,128,129,130,131],"Adenocarcinoma","Neoplasms","Carcinoma","Neoplasms, Glandular and Epithelial","Neoplasms by Histologic Type",[133],"Immune Infiltration",{"date":32,"type":33},{"date":109,"type":21},{"date":137,"type":21},"2028-06-15",{"name":113,"class":114},{"id":140,"slug":141,"hasResults":12,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":12,"sex":48,"minAge":18,"maxAge":94,"enrollmentInfo":146,"targetDuration":4,"studyType":22,"phases":148,"briefSummary":149,"conditions":150,"keywords":162,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":169,"startDateStruct":170,"completionDateStruct":171,"leadSponsor":173,"locationsCount":86},"100054087","phase-1-docetaxel-and-sx-682-in-recurrentmetastatic-head-and-neck-squamous-cell-carcinoma-salivary-gland-carcinoma-and-advanced-prostate-cancer-100054087","NCT07667400","Docetaxel and SX-682 in Recurrent\u002FMetastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer","Phase I\u002FII Trial of Docetaxel and SX-682 in Recurrent\u002FMetastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer","* INCLUSION CRITERIA:\n\nAll Participants\n\n* Age \\>= 18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) \\\u003C= 2\n* Participants must have adequate organ and marrow function as defined below:\n\n  * ANC \\>= 1,500\u002FmcL\n  * Hemoglobin (Hgb) \\>= 9 g\u002FdL\n  * Platelets (PLTs) \\>= 100,000\u002FmcL\n  * Creatinine clearance \\>= 50 mL\u002Fmin (by Cockroft-Gault formula)\n  * Total bilirubin \\\u003C= 1.5 x iULN (\\\u003C= 3 x ULN in participants with known\u002Fsuspected Gilbert s disease)\n  * ALT\u002FAST \\\u003C= 2.5 x iULN\n  * Activated partial thromboplastin time (aPTT) \\\u003C= 1.5 x iULN\n* Contraception as follows:\n* Women of child-bearing potential (WOCBP) must agree to use an effective method of contraception (barrier, hormonal, intrauterine device \\[IUD\\], surgical sterilization, abstinence) prior to study entry, for the duration of study treatment, and for up to 2 months after discontinuation of the study drugs. A participant may request a male partner to use an effective form of contraception to fulfill this requirement.\n* Men able to father a child must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of the study treatment and up to 4 months after discontinuation of the study drugs. A participant may request a female partner to use an effective form of contraception to fulfill this requirement. Men able to father a child must not freeze or donate sperm within the same period.\n* Nursing participants must be willing to discontinue nursing from study treatment initiation through one week after the last dose of study drugs.\n* Participants must be able to swallow oral medications.\n* Human immunodeficiency virus (HIV)-infected participants must have undetectable viral load (VL) and be on effective anti-retroviral therapy within 4 weeks prior to the study treatment initiation and have no history of opportunistic infections or Castleman s disease within 12 months prior to the study treatment initiation.\n* Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV VL.\n* Participants with evidence of chronic hepatitis C virus (HCV) infection must have undetectable HCV VL.\n* Participants must be able to understand and willing to sign a written informed consent document.\n\nParticipants with HNC\n\n* Histologically confirmed HNSCC (including oral cavity, oropharynx, larynx, hypopharynx, paranasal sinuses, nasopharynx) or SGC (including ACC and non-ACC) and recurrent\u002Fmetastatic (R\u002FM) or advanced incurable disease.\n* Prior treatment as follows:\n\n  * Participants with R\u002FM HNSCC must have prior systemic treatment (platinum-based chemotherapy and\u002For anti-PD(L)1 treatment).\n  * Participants with R\u002FM SGC may have any number of prior systemic treatment lines; prior systemic treatment not required for participation.\n  * Participants must not have received systemic anticancer treatment within 3 weeks prior to first treatment administration. Note: Treatment-related toxicities must have resolved to Grade \\\u003C2 or be minimal and not constitute a safety risk. Participants with SGC previously treated with hormonal therapies (e.g., drugs targeting the androgen receptor) may continue these drugs concomitantly with study therapy. Participants with bone metastases or hypercalcemia on intravenous bisphosphonate medications, denosumab, or similar agents, are eligible to participate and may continue this treatment.\n* Presence of \\>= 1 measurable lesion by RECIST v 1.1 criteria.\n\nParticipants with mCRPC\n\n* Documented histopathological confirmation of prostate cancer. If no pathologic report or specimen is available, participants may enroll with a history of clinical course consistent with the disease.\n* Participants must have mCRPC, defined as at least one lesion on TC-99 bone scan or at least one lesion that is measurable per RECIST 1.1.\n* Participants must need ADT as part of their cancer therapy (unless previous orchiectomy)\n* Castrate testosterone level (\\\u003C50 ng\u002Fdl or 1.7 nmol\u002FL)\n* Prior treatment as follows:\n\n  * DTX for mCRPC is allowed but participants must not have had progression while on docetaxel or within 3 months after completing DTX for mCRPC\n  * Participants must have been previously treated with modern anti-androgens such as abiraterone, enzalutamide, apalutamide, or darolutamide.\n* Progression defined as two consecutive rising PSA values at least 1 week apart or radiographic evidence of progression seen on computed tomography (CT) scan or TC- 99 bone scan.\n* Toxicities related to prior therapy, including surgery and\u002For radiation, must have resolved to \\\u003C Grade 1 per CTCAE v.6.0.\n\nEXCLUSION CRITERIA:\n\nAll participants\n\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to DTX, SX-682, or other agents used in study (e.g., polysorbate 80).\n* Known active brain metastases. Note: Participants with previously treated brain metastases are eligible if imaging at least four weeks prior to first trial treatment shows no evidence of progression and neurologic symptoms have resolved, have no new or enlarging brain metastases, and are not using glucocorticoids for at least a week prior to first trial treatment\n* Participants must not have received other investigational agents within 3 weeks prior to the first dose of the study drug(s).\n* Participants must not have received major surgery within 14 days prior to the first drug administration (minimally invasive procedures such as diagnostic biopsies are permitted). If participant underwent major surgery, they must have recovered adequately (according to the Principal Investigator) from the toxicity and\u002For complications from the intervention prior to starting study treatment.\n* Treatment (systemic) with any medications or substances that are moderate or strong inducers or moderate or strong inhibitors of cytochrome P450 (CYP3A4) listed at https:\u002F\u002Fwww.fda.gov\u002Fdrugs\u002Fdrug-interactions-labeling\u002Fdrug-development-and-druginteractions- table-substrates-inhibitors-and-inducers#table2-2,table3-3,table5-2 within 2 weeks or 5 half-lives (whichever is shorter) prior to the start of the study treatment.\n* Prior or concurrent malignancy whose natural history or treatment has potential to interfere with the safety or efficacy assessment of the study treatment.\n* Participants with serious uncontrolled intercurrent illness evaluated by medical history, electrocardiogram (EKG), and physical exam that would unacceptably increase risk for the participant or impair the ability to evaluate the endpoints of the study or that would limit compliance with study requirements.\n\nParticipants with HNC\n\n* Participants must not have received large-field radiotherapy within 2 weeks prior to first treatment administration. All residual treatment-related toxicities must have resolved to Grade \\\u003C2 (except for radiation-induced xerostomia\u002Fdysgeusia) or be minimal and not constitute a safety risk.\n* Positive pregnancy serum or urine beta-human chorionic gonadotropin (beta-hCG) test\n\nParticipants with mCRPC\n\n* Use of other medications for urinary symptoms including 5-alpha reductase inhibitors (finasteride and dutasteride) and alternative medications known to alter PSA (e.g., phytoestrogens and saw palmetto) within 1 week prior to the study treatment initiation.\n* Cancer related neuropathy at screening\n* Baseline QTcF \\>= 470 ms",{"count":147,"type":21},120,[53,54],"Background:\n\nHead and neck cancers (HNCs) account for about 5% of all cancers worldwide. They grow in the mouth, throat, nasal cavity, or salivary glands. Prostate cancer is the most common cancer in men in the United States. Survival rates for these cancers are lower than 50% if they spread to other parts of the body or return after treatment. Better treatments are needed.\n\nObjective:\n\nTo test a new drug (SX-682), combined with an approved drug (docetaxel, or DTX), in people with HNCs or prostate cancer.\n\nEligibility\n\nPeople aged 18 years and older with an HNC or prostate cancer that has returned after treatment or has spread.\n\nDesign:\n\nParticipants will be screened. They will have blood tests, imaging scans, and a test of their heart function. A tissue sample (biopsy) of the tumor may be taken.\n\nParticipants will take the study drugs in 3-week cycles. SX-682 is a tablet taken by mouth twice a day from Days 1 to 11 of each cycle. Participants will get a supply of the drug to take home. DTX is given on Day 8 of each cycle through a tube attached to a needle inserted into a vein in the arm. Participants will come to the clinic on Days 1 and 8 of every cycle. They will take both drugs for up to 6 cycles.\n\nParticipants will have follow-up visits 1 week and 1 month after they finish taking the drugs. Follow-ups will continue every 3 months for 2 years. Then they will have phone or email check-ins twice a year until 5 years have passed.",[151,152,153,154,155,156,157,158,159,160,27,161],"Head and Neck Cancer","Head and Neck Squamous Cell Carcinoma","Paranasal Sinus Neoplasms","Nasopharyngeal Carcinoma","Oropharyngeal Squamous Cell Carcinoma","Hypopharyngeal Cancer","Carcinoma of Larynx","Oral Squamous Cell Carcinoma","Salivary Gland Cancer","Adenoid Cystic Carcinoma","Metastatic Castration Resistant Prostate Cancer",[163,164,165,129,166,167,168],"Solid Tumors","Infusion","Chemotherapy","Head and Neck","Prostate","molecule inhibitor",{"date":32,"type":33},{"date":109,"type":21},{"date":172,"type":21},"2037-10-01",{"name":113,"class":114},{"id":175,"slug":176,"hasResults":12,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":183,"phases":4,"briefSummary":184,"conditions":185,"keywords":187,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":191,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":86},"100053604","prospective-monitoring-of-subjects-with-biochemically-recurrent-prostate-cancer-using-18fdcfpyl-100053604","NCT05588128","Prospective Monitoring of Subjects With Biochemically Recurrent Prostate Cancer Using 18FDCFPyL","A Study of Prospective Monitoring of Subjects With Biochemically Recurrent Prostate Cancer Using 18F-DCFPyL","* INCLUSION CRITERIA:\n* History of primary treatment for prostate cancer (either surgery or radiation)\n* Serum PSA \\>= 0.50\n* Serum testosterone \\>100\n* Age \\>=18 years\n* Men must agree to use highly effective contraception (surgical sterilization) for 7 days after every study agent administration. Note: abstinence, defined as no heterosexual sexual intercourse when this is in line with the preferred and usual lifestyle of the subject is also acceptable\n* The ability of a participant to understand and the willingness to sign a written informed consent document\n\nEXCLUSION CRITERIA:\n\n-Evidence of soft tissue disease on CT scan (or magnetic resonance imaging \\[MRI\\] as clinically indicated).\n\nNOTE: Lymph nodes \\\u003C= 1.5 cm in the shortest dimension are allowed.\n\n* Evidence of bone lesions on Tc99 bone scan\n* Prostatectomy within 1 year before the study intervention\n* Androgen deprivation therapy (ADT) within the 6 months before the study intervention\n* Systemic therapy for prostate cancer within the 6 months before the study intervention. Other investigational agents, excluding those involving standard of care chemotherapy, received within 6 months prior to the study intervention are allowed.",{"count":182,"type":21},350,"OBSERVATIONAL","Background:\n\nProstate cancer is the second leading cause of cancer-related death in American men. The disease recurs in up to 50,000 men each year after their early-stage disease was treated; however, at this stage, imaging scans are often unable to find the disease in the body. In this natural history study, researchers want to find out if a new radiotracer (18F-DCFPyL) injected before positron emission tomography (PET) imaging can help identify sites in the body with cancer.\n\nObjective:\n\nTo learn more about how 18F-DCFPyL PET\u002FCT scans detect change over time in men with recurrent prostate cancer.\n\nEligibility:\n\nMen aged 18 and older with prostate cancer that returned after treatment.\n\nDesign:\n\nParticipants will be screened with blood tests. They will also have a bone scan and a computed tomography (CT) scans of the chest, abdomen, and pelvis.\n\nParticipants will have an initial study visit. They will have a physical exam and blood tests. They will have a PET\u002FCT scan with 18F-DCFPyL. The radiotracer will be injected into a vein; this will take about 20 seconds. The PET\u002FCT scan will be done 1 to 2 hours later. Participants will lie still on a scanner table while a machine captures images of their body. The scan will take 45 minutes.\n\nParticipants will return for blood tests every 3 months.\n\nParticipants will return for additional scans with 18F-DCFPyL on this schedule:\n\nOnce a year if their previous scan was negative for prostate cancer.\n\nEvery 6 months if their previous scan was positive for prostate cancer.\n\nParticipants may be in the study up to 5 years.",[27,186],"Biochemically Recurrent",[188,189,190],"Cancer Of Prostate","Natural History","Imaging",{"date":32,"type":33},{"date":193,"type":33},"2023-03-21",{"date":195,"type":21},"2027-12-31",{"name":113,"class":114},{"id":198,"slug":199,"hasResults":12,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":204,"targetDuration":4,"studyType":22,"phases":206,"briefSummary":208,"conditions":209,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":215,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":222},"100053817","sacral-neuromodulation-for-male-overactive-bladder-moab-100053817","NCT06511141","Sacral Neuromodulation for Male Overactive Bladder (MOAB)","Sacral Neuromodulation for Male Overactive Bladder","Key Inclusion Criteria:\n\n1. Participants aged ≥ 18 years at the time of enrollment\n2. Able to complete bladder diaries and patient questionnaires\n3. Primary diagnosis of OAB (urinary urgency incontinence (UUI) or urinary frequency (UF)).\n4. Willing and capable to provide written informed consent and agrees to comply with specified evaluations at clinical investigational sites and attend all follow-up assessments for up to 1 year\n\nKey Exclusion Criteria:\n\n1. Any patient that is not a suitable candidate per investigator discretion\n2. Recent prostate therapy or procedure within the last 6 months at the time of enrollment\n3. Any neurological condition that could interfere with normal bladder function, including stroke, epilepsy, multiple sclerosis, Parkinson's disease, clinically significant peripheral neuropathy, or spinal cord injury (e.g., paraplegia)\n4. Previously implanted with a sacral neuromodulation device, including inactive SNM devices\n5. Any prior treatment with an Implantable Tibial Nerve Stimulation (ITNS)\n6. Positive response to Percutaneous Tibial Nerve Stimulation (PTNS) within the last 3 months at the time of enrollment\n7. Underwent an external trial with any sacral neuromodulation device and was deemed a non-responder by a physician\n8. Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study objectives at the discretion of the participating physician.\n9. Uncontrolled diabetes\n10. Known allergic reactions to components of the Axonics SNM System, including titanium, zirconia, polyurethane, epoxy, or silicone",{"count":205,"type":21},150,[207],"NA","To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients.",[210,211,212,27,213,214],"Overactive Bladder","Urinary Urgency Incontinence","Benign Prostatic Hyperplasia","Prostatectomy","Urinary Frequency",{"date":32,"type":33},{"date":217,"type":33},"2024-10-22",{"date":219,"type":21},"2028-12",{"name":221,"class":40},"Axonics, Inc.",21,{"id":224,"slug":225,"hasResults":12,"nctId":226,"briefTitle":227,"officialTitle":227,"acronym":228,"eligibilityCriteria":229,"healthyVolunteers":12,"sex":48,"minAge":18,"maxAge":4,"enrollmentInfo":230,"targetDuration":4,"studyType":22,"phases":232,"briefSummary":233,"conditions":234,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":86},"100053550","holep-prior-to-radiation-therapy-for-patients-with-lutsretention-and-concurrent-prostate-cancer-100053550","NCT03802851","HoLEP Prior to Radiation Therapy for Patients With LUTS\u002FRetention and Concurrent Prostate Cancer","HOLEP-RTPC","Inclusion Criteria:\n\n* Patients must be 18 years of age or older\n* Patients must have bothersome lower urinary tract symptoms (LUTS), defined by American Urological Association Symptom Score (AUA SS) of greater than or equal to 15 and\u002For as defined by a post-void residual of greater than or equal to 350mL and\u002For as defined by catheter dependence\n* Patients must be diagnosed with prostate cancer by pathological tissue analysis\n* Patients must have elected for radiation with androgen deprivation therapy as the primary treatment modality for their prostate cancer\n\nExclusion Criteria:\n\n* Patients who are under 18 years of age are not eligible\n* Patients who have a diagnosis of bladder cancer are not eligible.\n* Patients with prior treatment for prostate cancer are not eligible.\n* Patients with any type of prior prostate surgery (minimally invasive, endoscopic, or otherwise) including prior transurethral resection of the prostate (but excluding prior prostate biopsy) are ineligible.\n* Patients with known metastatic prostate cancer are ineligible\n* Patients who are enrolled in other surgical or international trials at the time of this study are not eligible",{"count":231,"type":21},30,[207],"To determine if holmium laser enucleation of the prostate (HoLEP) for the treatment of lower urinary tract symptoms (LUTS) and\u002For urinary retention alters the treatment course for patients concurrently diagnosed with prostate cancer.",[27,235],"Lower Urinary Tract Symptoms","2026-07-09",{"date":32,"type":33},{"date":239,"type":33},"2019-09-19",{"date":241,"type":21},"2035-01",{"name":243,"class":85},"University of Kansas Medical Center",{"id":245,"slug":246,"hasResults":12,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":4,"eligibilityCriteria":250,"healthyVolunteers":12,"sex":48,"minAge":251,"maxAge":4,"enrollmentInfo":252,"targetDuration":4,"studyType":22,"phases":254,"briefSummary":255,"conditions":256,"keywords":259,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":263,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":86},"100053279","a-study-of-mental-health-care-in-people-with-cancer-100053279","NCT06037954","A Study of Mental Health Care in People With Cancer","Mental Health Care Initiation Intervention for Older Adults With Cancer","Inclusion Criteria:\n\nPatients\n\n* Per medical record and\u002For self-report, diagnosed with breast, colorectal, lung, or prostate cancer at age 65 years or older\n* Per medical record and\u002For self-report, undergoing active cancer treatment (e.g., radiation, chemotherapy, immunotherapy, surgery) or within six months of completing treatment\n* Score of ≥5 on the Patient Health Questionnaire-9 (PHQ-9)\n* Per self-report, fluent in English\\*\\* \\*\\* Language verification: Prior to enrollment, patients will be asked the following two questions by a Clinical Research Coordinator (CRC) to verify English fluency necessary for participation in the study:\n\n  1. How well do you speak English? (must respond \"very well\" or \"well\" when given the choices of Very well, Well, Not well, Not at all, Don't know, or Refused)\n  2. What is your preferred language for healthcare? (must respond English)\n\nProviders\n\n* Per self-report, works in oncology, nursing, social work, psychology, or psychiatry\n* Per self-report, currently works in oncology at least 50% of the time\n* Per self-report, provided cancer care for at least three years at time of consent\n* Per self-report, fluent in English\n\nExclusion Criteria:\n\nPatients\n\n* Severely cognitively impaired as demonstrated by Blessed Orientation Memory Concentration scores of ≥ 11\n* Per research staff judgment and\u002For self-report, too ill or weak to complete study procedures\n* Per medical record and\u002For self-report, receiving hospice care at the time of enrollment\n* Per medical record and\u002For self-report, currently enrolled in mental health treatment\n\nProviders\n\n* N\u002FA","65 Years",{"count":253,"type":21},130,[207],"The purpose of this study is to look at mental health services for adults with depressed mood who were diagnosed with cancer at the age of 65 or older. This study will compare the usual approach for connecting older adults with depressed mood to mental health services with the Open Door for Cancer (OD-C) approach. We will find out if the OD-C approach is practical and useful for cancer patients who participate in the intervention and for providers who see or treat cancer patients.",[59,257,258,27],"Colorectal Cancer","Lung Cancer",[260,261,262],"65 years and older","Mental health care","23-218",{"date":32,"type":33},{"date":265,"type":33},"2023-09-07",{"date":267,"type":21},"2026-09",{"name":269,"class":85},"Memorial Sloan Kettering Cancer Center",{"id":271,"slug":4,"hasResults":12,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":12,"sex":48,"minAge":18,"maxAge":94,"enrollmentInfo":272,"targetDuration":4,"studyType":22,"phases":273,"briefSummary":149,"conditions":274,"keywords":275,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":277,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":282,"locationsCount":86},"100643883",{"count":147,"type":21},[53,54],[151,152,153,154,155,156,157,158,159,160,27,161],[163,164,165,129,166,167,168],"2026-07-01",{"date":278,"type":33},"2026-07-02",{"date":280,"type":21},"2026-07-07",{"date":172,"type":21},{"name":113,"class":114},{"id":284,"slug":4,"hasResults":12,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":94,"enrollmentInfo":285,"targetDuration":4,"studyType":22,"phases":286,"briefSummary":125,"conditions":287,"keywords":288,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":289,"startDateStruct":290,"completionDateStruct":291,"leadSponsor":292,"locationsCount":86},"100641793",{"count":123,"type":21},[54],[127,27,128,129,130,131],[133],{"date":278,"type":33},{"date":280,"type":21},{"date":137,"type":21},{"name":113,"class":114},{"id":294,"slug":295,"hasResults":12,"nctId":296,"briefTitle":297,"officialTitle":297,"acronym":298,"eligibilityCriteria":299,"healthyVolunteers":12,"sex":48,"minAge":18,"maxAge":4,"enrollmentInfo":300,"targetDuration":4,"studyType":22,"phases":302,"briefSummary":303,"conditions":304,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":318,"startDateStruct":319,"completionDateStruct":321,"leadSponsor":323,"locationsCount":325},"100597545","distance-based-exercise-to-preserve-function-and-prevent-disability-100597545","NCT07059884","Distance-Based Exercise to Preserve Function and Prevent Disability","DEFEND","Inclusion Criteria:\n\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Participants must have histologically confirmed diagnosis of one of the following cancers: anus, bladder, breast, cervix, colon\u002Frectum, endometrium, esophagus, gallbladder, head\u002Fneck, kidney, liver, lung, ovary, pancreas, prostate, sarcoma, stomach\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Participants must be initiating outpatient cytotoxic chemotherapy for curative intent of at least 10 weeks duration (with or without concurrent radiation, immunotherapy, or other targeted therapy). Patients must be enrolled and baseline measures collected on or before administration of their second cycle of cytotoxic therapy. Patients receiving outpatient cytotoxic chemotherapy for curative intent in the neoadjuvant or adjuvant setting are eligible. Patients receiving definitive chemoradiation for the tumors listed above, are also eligible. Regimens of immunotherapy or monoclonal antibodies ONLY are not eligible\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Age 18-64 years\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot have metastatic cancer\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot have documentation in the medical record of severe cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity. Examples would include unstable angina, recent myocardial infarction, oxygen-dependent pulmonary disease, and osteoarthritis requiring imminent joint replacement. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot be pregnant, because this study involves remotely delivered exercise, and cannot be breast-feeding as patients must be receiving cytotoxic chemotherapy, during which breast-feeding is contraindicated\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot have documentation in the medical record of current alcohol, substance abuse, or dementia\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Engaged in full time gainful employment of at least 30 hours per week at the time of cancer diagnosis\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Currently no self-report of engagement in competitive sports (e.g. not training for running races, triathlons, etc.) AND no self-report of twice weekly progressive resistance exercise training for at least 3 consecutive months within the past year\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Self-reported ability to walk for 6 minutes (use of assistive devices will be allowed)\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Not participating in another weight loss, physical activity, or dietary intervention clinical trial\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Predicted 6MWT distance of 550 meters or less\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Concurrent enrollment in treatment or supportive care trials (other than those focused on weight loss or exercise) is allowed with the permission of the Alliance Executive Officer and both studies' study chairs\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Eligibility is restricted to individuals who can comprehend and read English given that participation in the study will require the ability to read intervention materials and work with a coach through telehealth sessions\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): The trial is unable to accommodate the needs of deaf or blind participants as the study relies on language and visualization of exercise through telehealth sessions\n* CLINICAL STAKEHOLDER ELIGIBILITY CRITERIA: Clinicians and research staff from enrolling sites who meet following criterion will be deemed eligible to participate as a clinical stakeholder:\n\n  \\* Providing clinical care for participating patients on this study\n* CLINICAL STAKEHOLDER ELIGIBILITY CRITERIA: Ability to speak and understand English\n\nExclusion Criteria:\n\n\\-",{"count":301,"type":21},104,[207],"This clinical trial studies whether an exercise program can be successfully delivered to patients receiving treatment for cancer through virtual sessions and allow patients to exercise in their own home. Treatments for cancer can cause side effects such as fatigue and loss of strength. These side effects can make it difficult to work, take care of family, and do other things the patient wants to do. Preliminary research shows that exercise can help prevent some of these side effects, but it can be more difficult to start an exercise program when a patient is receiving cancer treatment. The exercise program in this study is delivered through telehealth (TH) video calls. The TH sessions are delivered by trained staff that supervise resistance exercises. The trained staff also provide guidance to the patient on completing unsupervised aerobic sessions on their own. This may be a successful way to deliver an exercise program and make it easier for cancer patients to exercise in their own home during treatment.",[305,306,307,59,308,309,310,311,58,312,313,314,258,151,61,315,27,316,317],"Localized Malignant Solid Neoplasm","Anal Cancer","Bladder (Urothelial, Transitional Cell) Cancer","Cervical Cancer","Colon Cancer","Endometrial Cancer","Esophageal Cancer","Gastric Cancer","Kidney Cancer","Liver Cancer","Pancreatic Cancer","Rectal Cancer","Sarcoma",{"date":278,"type":33},{"date":320,"type":33},"2026-02-11",{"date":322,"type":21},"2027-08-31",{"name":324,"class":85},"Alliance for Clinical Trials in Oncology",18,{"id":327,"slug":328,"hasResults":12,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":4,"eligibilityCriteria":332,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":333,"targetDuration":4,"studyType":22,"phases":335,"briefSummary":336,"conditions":337,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":339,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":86},"100522672","phase-1-a-pilot-presurgical-trial-of-regn5678-anti-psma-x-cd28-in-patients-with-high-risk-localized-prostate-cancer-followed-by-radical-prostatectomy-100522672","NCT06085664","A Pilot Presurgical Trial of REGN5678 (Anti-PSMA x CD28) in Patients With High-risk, Localized Prostate Cancer Followed by Radical Prostatectomy","A Pilot Presurgical Trial of REGN5678 (Anti-PSMA X CD28) in Patients With High-Risk, Localized Prostate Cancer Followed by Radical Prostatectomy","Inclusion Criteria:\n\n* Men ≥ 18 years of age\n* Histologically documented Gleason 8 or greater prostatic adenocarcinoma in at least 3 biopsy cores and at least 8 mm of disease on a single core of Gleason 8 or greater. Prostate biopsy within 3 months of screening is allowed for entry requirements. Prostate biopsy must be reviewed at MD Anderson Cancer Center. Patients with small cell, neuroendocrine, or transitional cell carcinomas or mixed histologies are not eligible\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) grade of 0 or 1\n* No evidence of metastatic disease as documented by technetium-99m (99mTc) bone scan and by computed tomography (CT) or magnetic resonance imaging (MRI) scans. Imaging may be obtained up to 60 days prior to enrollment\n* Localized or locally advanced disease deemed by the surgeon to be resectable. Patients must be appropriate candidates for radical prostatectomy plus pelvic lymph node dissection\n* No prior treatment for prostate cancer including prior surgery (excluding transurethral resection of the prostate \\[TURP\\]), cryoablation, pelvic lymph node dissection, radiation therapy, hormonal therapy or chemotherapy\n* Hemoglobin ≥ 11 g\u002FdL\n* Absolute neutrophil count ≥ 1.5 x 10\\^9\u002FL\n* Platelet count ≥ 100 x 10\\^9\u002FL\n* Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or estimated glomerular filtration rate \\> 50 mL\u002Fmin\u002F1.73 m\\^2. A 24-hour urine creatinine collection may substitute for the calculated creatinine clearance to meet eligibility criteria\n* Total bilirubin ≤ 1.5 x ULN\n\n  * NOTES: Patients with Gilbert's syndrome do not need to meet total bilirubin requirements provided their total bilirubin is not greater than their historical level. Gilbert's syndrome must be documented appropriately as past medical history\n* Aspartate aminotransferase (AST) ≤ 2.5 x ULN\n* Alanine aminotransferase (ALT) ≤ 2.5 x ULN\n* Alkaline phosphatase (ALP) ≤ 2.5 x ULN\n* Consent to MD Anderson laboratory protocol PA13-0291\n* Willing and able to comply with clinic visits and study-related procedures\n* Provide informed consent signed by study patient\n* To avoid risk of drug exposure through the ejaculate (even men with vasectomies), subjects must use a condom during sexual activity while on study drug and for 3 months following the last dose of study drug. If the subject is engaged in sexual activity with a woman of childbearing potential, a condom is required along with another effective contraceptive method consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies and their partners. Donation of sperm is not allowed while on study drug and for 3 months following the last dose of study drug\n\nExclusion Criteria:\n\n* Prior hormone therapy for prostate cancer including orchiectomy, antiandrogens, ketoconazole, or estrogens (5-alpha reductase inhibitors allowed), or luteinizing hormone-releasing hormone (LHRH) agonists\u002Fantagonists\n* Currently enrolled in another interventional study\n* Concurrent treatment with systemic corticosteroids (prednisone dose \\> 10 mg per day or equivalent) or other immunosuppressive drugs \\\u003C 14 days prior to treatment initiation. Steroids that are topical, inhaled, nasal (spray), or ophthalmic solution are permitted\n* History of or known or suspected autoimmune disease (exception\\[s\\]: subjects with vitiligo, resolved childhood atopic dermatitis, hypothyroidism, or hyperthyroidism that is clinically euthyroid at screening are allowed)\n* Known evidence of an active infection requiring systemic therapy such as human immunodeficiency virus (HIV), active hepatitis, or fungal infection. Patients with known HIV infection which is well-controlled (undetectable viral load by HIV ribonuclecid acid \\[RNA\\] polymerase chain reaction \\[PCR\\]) and CD4 counts greater than 350 are permitted to participate\n* History of clinically significant cardiovascular disease including, but not limited to:\n\n  * Myocardial infarction or unstable angina ≤ 6 months prior to treatment initiation\n  * Clinically significant cardiac arrhythmia\n  * Deep vein thrombosis, pulmonary embolism, stroke ≤ 6 months prior to treatment initiation\n  * Congestive heart failure (New York Heart Association class III-IV)\n  * Pericarditis\u002Fclinically significant pericardial effusion\n  * Myocarditis\n  * Endocarditis\n* History of major implant(s) or device(s), including but not limited to:\n\n  * Prosthetic heart valve(s)\n  * Artificial joints and prosthetics placed ≤ 12 months prior to treatment initiation\n  * Current or prior history of infection or other clinically significant adverse event associated with an exogenous implant or device that cannot be removed\n* Other prior malignancy (exceptions: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) ≤ 2 years prior to enrollment\n* Has received major surgery within 14 days of first administration of study drug\n* Encephalitis, meningitis, neurodegenerative disease (with the exception of mild dementia that does not interfere with activities of daily living \\[ADLs\\]) or uncontrolled seizures in the year prior to first dose of study therapy\n* Known history of, or any evidence of interstitial lung disease, or active, non-infectious pneumonitis (past 5 years)\n* Receipt of a live vaccine within 4 weeks of planned start of study medication\n* Prior allogeneic stem cell transplantation or recipients of organ transplants at any time, or autologous stem cell transplantation within 12 weeks of the start of study treatment\n* Any medical, psychological or social condition that in the opinion of the investigator, would preclude participation in this study",{"count":334,"type":21},42,[53,54],"To learn about the safety and effects of a drug called REGN5678 when it is given to patients with high-risk prostate cancer.",[27,338],"Radical Prostatectomy",{"date":278,"type":33},{"date":341,"type":33},"2023-12-04",{"date":343,"type":21},"2028-06-30",{"name":345,"class":85},"M.D. Anderson Cancer Center",{"id":347,"slug":348,"hasResults":12,"nctId":349,"briefTitle":350,"officialTitle":351,"acronym":4,"eligibilityCriteria":352,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":353,"targetDuration":4,"studyType":22,"phases":355,"briefSummary":356,"conditions":357,"keywords":360,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":363,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":368,"locationsCount":370},"100527642","phase-2-mdrt-in-prostate-cancer-treated-with-long-term-androgen-deprivation-therapy-in-the-stampede-trial-metanova-100527642","NCT06150417","MDRT in Prostate Cancer Treated With Long-term Androgen Deprivation Therapy in the STAMPEDE Trial (METANOVA)","Metastasis-directed Radiotherapy (MDRT) for Men With De-novo Oligometastatic Prostate Cancer Treated With Long-term Androgen Deprivation Therapy in the STAMPEDE Trial (METANOVA)","Inclusion Criteria:\n\n* Participant must be ≥ 18 years of age.\n* Participant must have an ECOG performance status ≤ 1.\n* Histologic confirmation of prostate adenocarcinoma of the prostate gland, with evidence of metastasis on imaging by conventional imaging (MRI, CT, or 99mTc bone scan) or PSMA PET\u002FCT. Biopsy of sites of metastasis is strongly encouraged, but not required.\n\n  * There must be at least 10-15 unstained slides from 2 cores of the highest tumor cellularity available.\n* Newly diagnosed disease with no prior treatment(surgery, radiation or systemic treatment, ie hormone therapy or chemotherapy) to the primary disease.\n\n  * Participants may have started LHRH agonist or antagonist therapy, and\u002For androgen receptor signaling inhibitor (ARSI) as long as it was not started more than 30 days before the participant is enrolled on this study.\n* In participants who undergo only conventional imaging, oligometastatic disease is defined as 1-5 discrete metastatic sites in the bone and\u002For extra-pelvic lymph node (LN) stations.\n\n  * Extra-pelvic LN stations are superior to the regional\u002Fpelvic LN stations. Pelvic LN stations commence at the bifurcation of the aorta and bifurcation of the proximal inferior vena cava to the common iliac veins.\n\n    * Radiographic criteria for a LN to be considered a metastatic focus is defined as short-axis diameter in the axial plane of ≥ 1.0 cm, with irregular border and\u002For heterogeneous morphology\n* In participants who undergo PSMA PET\u002FCT (in the presence or absence of conventional imaging), oligometastatic disease is defined as 1-10 PSMA avid bone lesions and\u002For extra-pelvic LN stations. The MI-RADS reporting system will be followed to guide PSMA PET interpretation\n\n  * In participants extra-pelvic nodal (M1a) disease only by PSMA PET\u002FCT and M0 by conventional imaging (i.e. extra-pelvic LN did not meet size criteria by CT), participant must meet 2 of 3 following criteria in order to be eligible:\n\n    * 1\\. PSA ≥ 40\n    * 2\\. Evidence of cN1 disease (pelvic LN)\n    * 3\\. Decipher score ≥ 0.89\n* Adequate organ and marrow function to receive treatment per treating physician\n* Medically fit for treatment and agreeable to follow-up.\n* Ability to understand and the willingness to sign a written informed consent.\n\nExclusion Criteria:\n\nParticipants with the presence of any of the following:\n\n* Castration resistant prostate cancer (CRPC).\n* Evidence of visceral or intracranial metastases.\n* Participant receiving any other investigational agents for cancer.\n* Participant is participating in a concurrent treatment protocol for cancer.\n* Unable to lie flat during or tolerate PET\u002FMRI, PET\u002FCT or SBRT.\n* Prior definitive treatment to the primary prostate cancer or pelvis.\n* Participant with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled diabetes (HgA1c \\> 10), active pituitary or adrenal dysfunction, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* History of another active malignancy within the previous 2 years, except for non-melanoma skin cancer, non-muscle invasive bladder cancer, or a malignancy that is considered cured with minimal risk of recurrence\n* Active Crohn's disease or ulcerative colitis despite medical management.\n* Refusal to sign informed consent.\n* Any condition that in the opinion of the investigator would preclude participation in this study",{"count":354,"type":21},200,[54],"The purpose of this study is to find out if giving radiation therapy (RT) to areas of metastatic prostate cancer at the time a participant is diagnosed will help control disease better than the usual treatment. This treatment is called metastasis-directed radiotherapy (MDRT).\n\nThe usual treatment for prostate cancer that has spread to other parts of the body is to give lifelong treatment with hormone therapy (also known as androgen deprivation therapy or ADT). Participants may also be given prostate RT even if the disease is metastatic. Participants will receive hormone therapy (the standard treatment for prostate cancer) for 12 months. The hormone therapy agents may be taken by mouth or given as an injection. Participants will also have prostate RT. Up to 50 participants will have surgery to remove the prostate instead of having prostate RT. A portion of the participants will be randomized to receive MDRT to areas where the cancer has spread. For participants who have surgery to remove their prostate, they will be asked to allow tissue samples collected during the surgery to be sent to an outside lab for research tests and extra blood samples drawn for research tests before starting the study, and at the time the cancer becomes worse if applicable. Participation in the study will last approximately 12 months, and will be followed by their doctor for up to five years per standard of care.\n\nThe main goal is to compare the efficacy of the standard of care (standard systemic therapy + definitive prostate-directed local therapy) versus the standard of care with metastasis-directed radiotherapy (MDRT) for consolidation of metastatic disease.",[27,358,359],"Malignant Neoplasm of Prostate","Secondary Malignant Neoplasm of Prostate",[361],"Metastasis-directed Radiotherapy","2026-06-30",{"date":276,"type":33},{"date":365,"type":33},"2024-07-01",{"date":367,"type":21},"2028-12-01",{"name":369,"class":85},"Case Comprehensive Cancer Center",2,{"id":372,"slug":373,"hasResults":12,"nctId":374,"briefTitle":375,"officialTitle":375,"acronym":4,"eligibilityCriteria":376,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":377,"targetDuration":4,"studyType":22,"phases":379,"briefSummary":380,"conditions":381,"keywords":382,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":387,"startDateStruct":388,"completionDateStruct":390,"leadSponsor":392,"locationsCount":86},"100415671","multiparametric-magnetic-resonance-imaging-of-the-prostate-to-assess-disease-progression-and-genomics-in-patients-undergoing-active-surveillance-for-prostate-cancer-100415671","NCT04692675","Multiparametric Magnetic Resonance Imaging of the Prostate to Assess Disease Progression and Genomics in Patients Undergoing Active Surveillance for Prostate Cancer","* INCLUSION CRITERIA:\n* Participants must have confirmed histopathological diagnosis of adenocarcinoma of the prostate within 2 years prior to study entry. Pathologic diagnosis must be confirmed by Laboratory of Pathology, NCI. If archival tissue is unavailable or insufficient for this purpose, a fresh biopsy will be collected.\n* Biopsy confirmed prostate cancer with Gleason less than or equal to 3+4=7 (primary pattern 3)\n* Clinical stage: cT1C or cT2A\n* Adult males, greater than or equal to 18 years old\n\nNOTE: Children are excluded because prostate cancer is not common in pediatric populations. Women are not eligible because this disease occurs only in men.\n\n* Ability of subject to understand and the willingness to sign a written informed consent document All participants should have a consent signed that demonstrates an understanding of active surveillance and the decision to choose active surveillance for their prostate cancer.\n* Subjects must be co-enrolled to NCI protocol 16-C-0010 Care of the Prostate Cancer Patient and Prospective Procurement of Prostate Cancer Tissue\n\nEXCLUSION CRITERIA:\n\n* Metastatic prostate cancer\u002Flocally advanced disease\n* Previous radiation to the pelvis\n* Contraindications to prostate biopsy, including:\n\n  * Bleeding disorder that is not currently treated and stable with normal INR values greater than 2 and PT, PTT less than or equal to 1.5 times the upper limit of normal value.\n  * Severe immunocompromise with CD4 count of less than 200 in HIV patients and bone marrow transplantation patients and or patients with severe combined immunodeficiency.\n  * Severe hemorrhoids grade 3 and above\n  * Prior surgery in the pelvis that prevents accurate imaging or biopsy including low anterior resection or abdominoperineal resection.\n  * Prior focal or whole gland therapy of the prostate for prostate cancer\n* Contraindication to mpMRI, including allergy or sensitivity to contrast agents or insufficient renal function to safely tolerate MRI contrast agent\n* mpMRI evidence of greater than or equal to T3 disease, including seminal vesicle invasion (SVI), extraprostatic extension (EPE) or locoregional spread of disease\n* Any other medical conditions deemed by the PI or associates to make the participants ineligible for protocol procedures",{"count":378,"type":21},508,[207],"Background:\n\nActive surveillance (AS) is a standard approach to treat low and intermediate risk prostate cancer. For AS, disease progression is monitored. AS uses biopsies, prostate specific antigen (PSA) blood tests, and other tools. Researchers want to see if multiparametric magnetic resonance imaging (mpMRI) can help improve AS.\n\nObjective:\n\nTo see if mpMRI can improve how people are monitored during AS.\n\nEligibility:\n\nMen age 18 and older who have been diagnosed with prostate cancer within the last 2 years.\n\nDesign:\n\nParticipants will undergo AS. Their PSA level will be checked once a year via blood test. They will have a digital rectal exam once a year.\n\nParticipants will have biopsies every 2-3 years. Needles will be put into different parts of the prostate. The needles are guided by ultrasound imaging.\n\nParticipants will also have targeted biopsies with mpMRI and MRI guided fusion (MRI-US fusion). MRI-US fusion combines previous MRI images with live ultrasound images. For MRIs, participants will lie on their stomach on the scanner table. A coil may be placed in the rectum.\n\nParticipants will have a physical exam and medical record review at least every 3 years. Their weight and vital signs will be checked. They will give data about their daily activities, side effects, and symptoms.\n\nEvery 2-3 years, participants will fill out surveys about their prostate health and quality of life.\n\nParticipants may give blood, urine, prostate secretion, and saliva samples. The samples will be used for research.\n\nParticipation will last for as long as the participant does not need actual treatment for his prostate cancer.",[27],[383,384,385,386],"Gleason Score","PSA","Progression","Biopsy",{"date":276,"type":33},{"date":389,"type":33},"2022-11-18",{"date":391,"type":21},"2031-09-01",{"name":113,"class":114},{"id":394,"slug":395,"hasResults":12,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":4,"eligibilityCriteria":399,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":400,"targetDuration":4,"studyType":22,"phases":402,"briefSummary":403,"conditions":404,"keywords":405,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":414,"locationsCount":86},"100641168","sexual-health-communication-skills-training-intervention-for-patients-with-prostate-cancer-100641168","NCT07655557","Sexual Health Communication Skills Training Intervention for Patients With Prostate Cancer","Pilot Testing a Sexual Health Communication Skills Training Intervention for Patients With Prostate Cancer","Inclusion Criteria:\n\n* Adult male with PCa at least 18 years of age\n* Speak English\n* Reside in the U.S.\n* Have internet\u002Fweb access, and\n* Report current bother due to sexual dysfunction\n* Capacity and willingness to provide consent\n* Have an appointment with a PCa provider at NYU Langone Health during the study accrual period\n\nExclusion Criteria:\n\n* Individual with impaired decision-making capacity.\n* Participation in another part of this study (prior aim)",{"count":401,"type":21},100,[207],"This is a pilot randomized controlled trial of a sexual health communication skills training multimedia intervention (Starting the Conversation \\[STC\\] adapted for patients with prostate cancer \\[PCa\\]) to improve patients' ability to communicate with providers about their sexual health concerns during PCa care compared to a time and attention control arm.",[27],[27,406,407],"Sexual Health","Health Communication","2026-06-29",{"date":276,"type":33},{"date":411,"type":21},"2026-08-01",{"date":413,"type":21},"2028-10-31",{"name":415,"class":85},"NYU Langone Health",{"id":417,"slug":418,"hasResults":12,"nctId":419,"briefTitle":420,"officialTitle":421,"acronym":4,"eligibilityCriteria":422,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":423,"targetDuration":4,"studyType":22,"phases":425,"briefSummary":426,"conditions":427,"keywords":431,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":437,"startDateStruct":438,"completionDateStruct":440,"leadSponsor":442,"locationsCount":86},"100640146","phase-2-prostate-specific-membrane-antigen-psma-imaging-for-detection-of-residual-and-metastatic-prostate-cancer-100640146","NCT07593079","Prostate Specific Membrane Antigen (PSMA) Imaging for Detection of Residual and Metastatic Prostate Cancer","Optimizing PSMA Imaging for Enhanced Detection of Residual and Metastatic Prostate Cancer in Low PSA Recurrence (OPERA) Study","Inclusion Criteria:\n\n* Histologically or cytologically confirmed biochemically recurrent prostate cancer, with original diagnosis no more than 2 years from date of consent.\n* Intermediate unfavorable or high-risk prostate cancer.\n* All patients under consideration for radiation therapy, either at the time of first recurrence or in salvage radiation therapy will be included.\n* Patients who have started bicalutamide up to a maximum of 3 days prior to randomization will be allowed to be on protocol. Otherwise, a washout period of at least 42 days will be required.\n* Biological males, at least 18 years of age.\n* Prostate specific antigen (PSA) \\\u003C 1.0 ng\u002FmL.\n* Agreement to adhere to Lifestyle Considerations throughout study duration\n* Ability to understand and willingness to sign an IRB approved written informed consent document.\n\nExclusion Criteria:\n\n* Patients currently on androgen deprivation therapy (ADTs).\n* Currently receiving any other investigational agents.\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to POSLUMA, furosemide, bicalutamide, or other agents used in the study.",{"count":424,"type":21},20,[54],"This is a randomized, open-label, pilot study assessing the impact of a short course of bicalutamide on PSMA expression in patients with prostate cancer belonging to the intermediate unfavorable or high risk group, who have low levels of PSA. Adult patients with biochemically recurrent prostate cancer (BCR PCa) who have a PSA of less than 1.0 ng\u002FmL and who have undergone complete prostatectomy and\u002For will be undergoing radiotherapy, in combination with standard of care bicalutamide, will be recruited to this study. Patients will be randomized in a 1:1 ratio into Group A (baseline PSMA PET\u002FCT only with bicalutamide standard of care) or Group B (baseline PSMA PET\u002FCT and an additional PSMA PET\u002FCT after 2 weeks of bicalutamide).",[27,100,428,429,430],"Metastatic Prostate Cancer","Prostate Cancer Recurrent","Prostate Cancer Metastatic",[432,433,434,435,436],"Prostate cancer","Low PSA","PSMA PET","BCR","Bicalutamide",{"date":276,"type":33},{"date":439,"type":21},"2026-07-31",{"date":441,"type":21},"2027-10-31",{"name":443,"class":85},"Washington University School of Medicine",{"id":445,"slug":446,"hasResults":12,"nctId":447,"briefTitle":448,"officialTitle":449,"acronym":450,"eligibilityCriteria":451,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":452,"targetDuration":4,"studyType":22,"phases":454,"briefSummary":455,"conditions":456,"keywords":461,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":474,"startDateStruct":475,"completionDateStruct":477,"leadSponsor":479,"locationsCount":481},"100630129","non-inferiority-study-comparing-salvage-pelvic-radiotherapy-in-25-fractions-625-gy25-versus-20-fractions-525-gy20-for-recurrent-prostate-cancer-after-surgery-100630129","NCT07483658","Non-inferiority Study Comparing Salvage Pelvic Radiotherapy in 25 Fractions (62.5 Gy\u002F25) Versus 20 Fractions (52.5 Gy\u002F20) for Recurrent Prostate Cancer After Surgery.","Non-Inferiority Study Comparing Hypofractionated Post-Operative Salvage Radiotherapy Regimens: 45\u002F62.5 Gy in 25 Fractions vs. 43\u002F52.5 Gy in 20 Fractions for Grade 2+ GU or GI Toxicity (HYP-OP-RT)","HYP-OP-RT","Inclusion Criteria:\n\n* Histologically confirmed prostate adenocarcinoma.\n* Prior radical prostatectomy with detectable PSA (≥0.2 ng\u002FmL).\n* No evidence of distant metastasis (confirmed via bone scan and CT\u002FMRI or TEP-PSMA if PSA is above 0.5 ng \u002Fml).\n* Patient with Nodal recurrence within the pelvis are eligible\n* ECOG performance status 0-2.\n* Age ≥ 18 years.\n* Adequate baseline renal, hepatic, and hematologic function.\n\nExclusion Criteria:\n\n* Prior pelvic radiotherapy.\n* Macroscopic local relapse on imaging\n* Presence of metastatic disease.\n* Active inflammatory bowel disease or other GI conditions predisposing to radiation toxicity.\n* Uncontrolled comorbidities affecting study participation.\n* Prior systemic therapy for recurrent prostate cancer (except ADT within 6 months).",{"count":453,"type":21},434,[207],"Study Overview This research compares two types of post-operative salvage radiotherapy (SRT) for men with prostate cancer who have had surgery but show signs of recurrence (detectable PSA). The goal is to see if a shorter treatment schedule is as safe and effective as the standard schedule.\n\nWhy is this study important? After prostate surgery, cancer can return in up to 70-80% of high-risk patients. Radiotherapy helps control this, but the best way to deliver it-especially the number of sessions and whether to treat the pelvic area-is still being studied. Shorter treatments could mean less time in therapy and better quality of life, if such treatments are proven safe.\n\nWhat is being compared?\n\nStandard treatment (Arm A):\n\n25 sessions (about 5 weeks) Prostate bed: 62.5 Gy Pelvis: 45 Gy\n\nShorter treatment (Arm B):\n\n20 sessions (about 4 weeks) Prostate bed: 52.5 Gy Pelvis: 43 Gy\n\nBoth groups may also receive hormone therapy (ADT) for 6-24 months.\n\nMain Goal To check if the shorter treatment causes no more side effects (urinary or bowel problems) than the standard treatment, while keeping cancer control similar.\n\nOther Things to be Measured\n\nCancer control (PSA levels, spread of disease) Survival Quality of life (urinary, bowel, sexual health questionnaires)\n\nWho can join?\n\nMen who:\n\nHad prostate surgery Have a detectable PSA (≥0.2 ng\u002FmL) No distant metastasis Are in good general health (ECOG 0-2)\n\nHow long will the study last?\n\nAbout 12 years total:\n\n2 years to enroll patients 10 years of follow-up",[457,458,27,28,459,460],"Reccurent\u002FMetastatic Solid Tumor Disease","Prostate Cancer (Post Prostatectomy)","Neoplasm Recurrence, Local","Biochemical Recurrence of Malignant Neoplasm of Prostate",[462,463,464,465,466,467,468,469,470,471,472,473],"Radiotherapy, Adjuvant","Radiotherapy, Intensity-Modulated","Radiotherapy, High-Dose Hypofractionated","Pelvic Radiotherapy","Androgen Deprivation Therapy","Randomized Controlled Trials","Noninferiority Trials","Quality of Life","Treatment Outcome","Gastrointestinal Diseases \u002F chemically induced","Urinary Tract Diseases \u002F chemically induced","Radiation Injuries",{"date":276,"type":33},{"date":476,"type":33},"2026-05-13",{"date":478,"type":21},"2036-02",{"name":480,"class":85},"CHU de Quebec-Universite Laval",4,{"id":483,"slug":484,"hasResults":12,"nctId":485,"briefTitle":486,"officialTitle":487,"acronym":4,"eligibilityCriteria":488,"healthyVolunteers":12,"sex":48,"minAge":18,"maxAge":4,"enrollmentInfo":489,"targetDuration":4,"studyType":22,"phases":491,"briefSummary":492,"conditions":493,"keywords":495,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":501,"lastUpdatePostDateStruct":502,"startDateStruct":503,"completionDateStruct":505,"leadSponsor":507,"locationsCount":508},"100615767","care-tool-study-aim-3-100615767","NCT07296887","CARE Tool Study Aim 3","Implement and Evaluate the CARE Tool in a Randomized Trial","Inclusion Criteria for Implementation champions:\n\n\\- Members of the cancer care team (e.g., physicians, nurses, research coordinators, financial navigators, social workers) that work with patients receiving treatment for gynecologic, lung, prostate, or colorectal cancer; or members of the billing team and employee of Siteman Cancer Center, Barnes Jewish Hospital, Washington University, Delbert Day Cancer Institute at Phelps Health, or Alton Memorial Hospital\n\nExclusion Criteria for Implementation champions:\n\n* Implementation champions are ineligible if they are non-employees of Siteman Cancer Center, Barnes Jewish Hospital, Washington University, Delbert Day Cancer Institute at Phelps Health, or Alton Memorial Hospital\n* Do not treat patients for gynecologic, prostate, lung, or colorectal cancer\n\nInclusion Criteria for Patients:\n\n* Age 18 and over\n* Primary or recurrent diagnosis of gynecologic, prostate, lung, or colorectal cancer in the last 12 months\n* Receiving cancer treatment from Siteman Cancer Center, Delbert Day Cancer Institute at Phelps Health, or Alton Memorial Hospital\n* Self-reported ability to read and speak English\n\nExclusion Criteria for Patients:\n\n* Under the age of 18\n* Not diagnosed with gynecologic, prostate, lung, or colorectal cancer within the previous 12 months from recruitment\n* Not receiving care at Siteman Cancer Center, Delbert Day Cancer Institute at Phelps Health, or Alton Memorial Hospital\n* Cannot give consent due to cognitive or emotional barriers",{"count":490,"type":21},430,[207],"This study is a multi-site randomized trial to study the implementation of the CARE Tool and evaluate the CARE Tool. The CARE Tool is a web-based tool that gives people information about cancer care costs, health insurance, and resources to help with costs. Overall, the study aims to help patients with cancer overcome barriers they face navigating insurance and accessing financial resources.",[494,27,258,257],"Gynecologic Cancer",[496,497,498,499,500],"Insurance","Insurance coverage","Cancer","Cost of medical care","Financial toxicity","2026-06-27",{"date":276,"type":33},{"date":504,"type":33},"2026-04-08",{"date":506,"type":21},"2028-07-31",{"name":443,"class":85},3,{"id":510,"slug":4,"hasResults":12,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":511,"targetDuration":4,"studyType":183,"phases":4,"briefSummary":184,"conditions":512,"keywords":513,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":501,"lastUpdatePostDateStruct":514,"startDateStruct":515,"completionDateStruct":516,"leadSponsor":517,"locationsCount":86},"100484444",{"count":182,"type":21},[27,186],[188,189,190],{"date":362,"type":33},{"date":193,"type":33},{"date":195,"type":21},{"name":113,"class":114},{"id":519,"slug":520,"hasResults":12,"nctId":521,"briefTitle":522,"officialTitle":523,"acronym":4,"eligibilityCriteria":524,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":525,"targetDuration":4,"studyType":22,"phases":527,"briefSummary":528,"conditions":529,"keywords":530,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":534,"lastUpdatePostDateStruct":535,"startDateStruct":536,"completionDateStruct":537,"leadSponsor":539,"locationsCount":86},"100634697","phase-1-a-phase-1-study-of-bpx-601-car-t-cell-therapy-in-adult-participants-with-prostate-cancer-that-has-returned-is-resistant-to-treatment-and-has-spread-100634697","NCT07543055","A Phase 1 Study of BPX-601 CAR T-Cell Therapy in Adult Participants With Prostate Cancer That Has Returned, is Resistant to Treatment and Has Spread","A Phase 1, Open-Label, Dose-Escalation Study of BPX-601, an Anti-PSCA CAR T Cell Drug Product, in Relapsed\u002FRefractory Metastatic Castration-Resistant Prostate Cancer","Key Inclusion Criteria:\n\n1. Histologically or cytologically confirmed diagnosis of hormone-refractory adenocarcinoma of the prostate without pure small cell carcinoma\n2. Metastatic, Castration-Resistant Prostate Cancer (mCRPC) with PSA value at screening ≥4 ng\u002FmL that has progressed within 6 months prior to screening, as defined in the protocol\n3. Has received ≥2 lines prior systemic therapy approved in the metastatic and\u002For castration-resistant setting \\[in addition to Androgen Deprivation Therapy (ADT)\\] including at least 1 second-generation anti-androgen therapy (eg, abiraterone, enzalutamide, apalutamide, or darolutamide)\n4. Has had either orchiectomy OR is on Luteinizing Hormone-Releasing Hormone (LHRH) agonist or antagonist therapy with serum testosterone \\\u003C50 ng\u002FdL AND agrees to stay on LHRH agonist or antagonist therapy during the study\n\nKey Exclusion Criteria:\n\n1. Structurally unstable bone lesions suggesting impending fracture\n2. Clinical or radiographic evidence of deep vein thrombosis, pulmonary embolism, or other known thromboembolic event that has not been definitively treated. Participants with prior history of coagulopathy must be on low-molecular weight heparin prophylaxis or prophylactic dose of oral anticoagulant and asymptomatic within 4 weeks of the planned BPX-601 infusion\n3. Inadequate renal function defined by creatinine clearance \\\u003C60 mL\u002Fmin calculated by 24-hour urine collection or using the Cockcroft-Gault formula\n4. Inadequate hepatic function defined by Aspartate aminotransferase (AST) and\u002For Alanine aminotransferase (ALT) \\>2.5 × ULN or \\>5 × ULN, if liver metastases, and\u002For total bilirubin \\>1.5 × ULN, as described in the protocol\n5. Inadequate bone marrow function defined by Absolute Neutrophil Count (ANC) \\\u003C1.5 × 10\\^9\u002FL or platelet count \\\u003C150 × 10\\^9\u002FL. At least 7 days must have passed since the last dose of filgrastim (or 14 days since the last dose of pegfilgrastim) and at least 7 days must have passed since the last platelet transfusion at the time of ANC or platelet count.\n\nNote: Other protocol-defined Inclusion\u002FExclusion criteria apply",{"count":526,"type":21},36,[53],"This study will test a study drug called BPX-601, a CAR-T cell product manufactured from the patient's own T-cells, to see if it can help treat advanced prostate cancer. BPX-601 is a drug that is only used in clinical studies.\n\nThe study is looking at:\n\n* What side effects BPX-601 might cause\n* What is the best dose of BPX-601\n* How well BPX-601 may work to destroy prostate cancer",[27],[531,532,533],"Relapsed\u002FRefractory (R\u002FR)","Metastatic","Castration-Resistant","2026-06-26",{"date":362,"type":33},{"date":280,"type":21},{"date":538,"type":21},"2031-04-25",{"name":540,"class":40},"Regeneron Pharmaceuticals",{"id":542,"slug":543,"hasResults":12,"nctId":544,"briefTitle":545,"officialTitle":546,"acronym":547,"eligibilityCriteria":548,"healthyVolunteers":12,"sex":48,"minAge":18,"maxAge":549,"enrollmentInfo":550,"targetDuration":4,"studyType":183,"phases":4,"briefSummary":551,"conditions":552,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":534,"lastUpdatePostDateStruct":567,"startDateStruct":568,"completionDateStruct":570,"leadSponsor":572,"locationsCount":574},"100602476","destiny-pantumour04-100602476","NCT07124000","DESTINY-PANTUMOUR04","Effectiveness of T-DXd Across HER2-positive Solid Tumors in Patients Who Have Received Prior Systemic Treatment and Have no Satisfactory Alternative Treatment Options: A Hybrid Observational Study","DP-04","Inclusion Criteria:\n\n1. Adults aged ≥18 years\n2. Patients with locally advanced, unresectable, or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment for metastatic or advanced disease and have no satisfactory alternative treatment options as determined by the Investigator (see Exclusion Criterion 1 for excluded solid tumors);\n3. A clinician decision has been made for treatment with T-DXd in accordance with the FDA label;\n4. HER2-positive (IHC 3+) by local testing prior to study enrolment at the time of signed and dated informed consent;\n5. Patients who are willing and able to provide a signed and dated informed consent.\n\nExclusion Criteria:\n\n1. Primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the colon or rectum, NSCLC, adenocarcinoma of the gastric body or gastroesophageal junction or hematological malignancies;\n2. Prior T-DXd therapy;\n3. Patients without a baseline assessment of tumor burden undertaken prior to initiating T-DXd.\n4. Patient is participating in a clinical trial at time of enrolment","130 Years",{"count":401,"type":21},"This study will evaluate the effectiveness of T-DXd in patients with HER2-positive (IHC 3+) locally advanced, unresectable, or metastatic solid tumors who have received prior systemic treatment for metastatic or advanced disease and have no satisfactory alternative treatment options in a real-world setting in the US",[553,306,554,308,310,311,58,555,151,314,556,557,558,559,61,315,27,560,159,317,561,562,563,564,565,566,64],"Adenocarcinoma (NOS)","Bladder Cancer","Gastrointestinal Stromal Tumour","Melanoma","Mouth Cancer","Nasopharangeal Cancer","Neuroendocrine, Gastrointestinal Cancer","Renal Cell Carcinoma","Small Cell Lung Cancer","Testicular Cancer","Throat Cancer","Thyroid Cancer","Urethral Cancer","Vaginal Cancer",{"date":408,"type":33},{"date":569,"type":33},"2025-09-18",{"date":571,"type":21},"2028-03-30",{"name":573,"class":40},"AstraZeneca",17,{"id":576,"slug":577,"hasResults":12,"nctId":578,"briefTitle":579,"officialTitle":580,"acronym":4,"eligibilityCriteria":581,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":582,"targetDuration":4,"studyType":22,"phases":584,"briefSummary":585,"conditions":586,"keywords":590,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":534,"lastUpdatePostDateStruct":606,"startDateStruct":607,"completionDateStruct":609,"leadSponsor":611,"locationsCount":613},"100595161","phase-3-this-study-will-explore-whether-a-combination-of-the-investigational-drug-mevrometostat-pf-06821497-and-enzalutamide-will-work-better-than-taking-enzalutamide-alone-in-participants-with-mcspc-who-are-arpi-nave-100595161","NCT07028853","This Study Will Explore Whether a Combination of the Investigational Drug Mevrometostat (PF-06821497) and Enzalutamide Will Work Better Than Taking Enzalutamide Alone in Participants With mCSPC Who Are ARPI naïve.","A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF MEVROMETOSTAT (PF-06821497) WITH ENZALUTAMIDE IN METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (MEVPRO-3)","Inclusion Criteria\n\n* Male participants aged ≥18 years (or the minimum age of consent in accordance with local regulations) at screening.\n* Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features.\n* Metastatic prostate cancer documented by positive bone scan (for bone disease) or metastatic lesion(s) on CT or MRI (for soft tissue\u002Fvisceral disease).\n* Resolution of acute effects of any prior therapy to either baseline severity or CTCAE Grade ≤1 (except for AEs which do not constitute a safety risk in the investigator's judgement).\n* Participants must have ECOG PS 0 or 1.\n\nExclusion Criteria\n\n* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation\u002Fbehavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.\n* Clinically significant cardiovascular disease.\n* Known or suspected brain metastasis or active leptomeningeal disease.\n* Participants must be treatment naïve at the mCSPC stage, eg, participants cannot have received any cytotoxic chemotherapy with the following exceptions: Treatment with first-generation antiandrogen (ADT) agents is allowed for mCSPC.\n* Previous administration with an investigational product (drug or vaccine) within 30 days.\n* Use of 5-alpha reductase inhibitors is prohibited within 28 days of randomization.\n* Prior surgery from which the participant has not fully recovered at least 28 days prior to randomization\n* Current use or anticipated need for drugs that are known strong CYP3A4\u002F5 inhibitors and inducers (with exception of enzalutamide as part of this study).\n* Inadequate organ function.\n* Known allergic or hypersensitivity reactions to mevrometostat or its excipients or to enzalutamide or its excipients.",{"count":583,"type":21},1000,[24],"This study will explore whether a combination of the investigational drug mevrometostat (PF-06821497) and enzalutamide will work better than taking enzalutamide alone in participants with mCSPC who are ARPI naïve and have not yet received chemotherapy in the mCSPC setting.",[587,588,27,589],"Metastatic Castration Sensitive Prostate Cancer (mCSPC)","Hormone Sensitive Prostate Cancer","Cancer of the Prostate",[588,591,592,593,594,595,596,597,598,432,599,600,601,602,603,604,605],"Mevrometostat","Metastatic castration sensitive prostate cancer","PF-06821497","EZH2","enhancer of zeste homologue-2","enzalutamide","mCSPC","HSPC","castrate sensitive prostate cancer","prostatecancer-study.com","Phase 3","efficacy","safety","pharmacokinetics","pharmacodynamics",{"date":362,"type":33},{"date":608,"type":33},"2025-09-28",{"date":610,"type":21},"2034-12-08",{"name":612,"class":40},"Pfizer",341,{"id":615,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":616,"targetDuration":4,"studyType":22,"phases":617,"briefSummary":25,"conditions":618,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":534,"lastUpdatePostDateStruct":619,"startDateStruct":620,"completionDateStruct":621,"leadSponsor":622,"locationsCount":41},"100587234",{"count":20,"type":21},[24],[27,28],{"date":408,"type":33},{"date":35,"type":33},{"date":37,"type":21},{"name":39,"class":40},{"id":624,"slug":625,"hasResults":12,"nctId":626,"briefTitle":627,"officialTitle":628,"acronym":629,"eligibilityCriteria":630,"healthyVolunteers":12,"sex":17,"minAge":631,"maxAge":4,"enrollmentInfo":632,"targetDuration":4,"studyType":22,"phases":633,"briefSummary":634,"conditions":635,"keywords":636,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":641,"lastUpdatePostDateStruct":642,"startDateStruct":643,"completionDateStruct":644,"leadSponsor":646,"locationsCount":4},"100642481","water-vapor-ablation-for-grade-group-3-prostate-cancer-100642481","NCT07652164","Water Vapor Ablation for Grade Group 3 Prostate Cancer","Vanquish® Water Vapor Ablation for Grade Group 3 PrOstate CanceR: A Multicenter Single Arm Study","VAPOR 3","Inclusion Criteria:\n\n* Participant has been diagnosed with Grade Group 3 (GG3) intermediate risk prostate cancer.\n* ≤20 ng\u002Fml PSA.\n* PSA density ≤0.15\n* ≥50 years of age; with life expectancy of ≥10 years.\n* Clinical cancer stage less than or equal to T2c (tumor may involve both sides of the prostate but without evidence that tumor extends outside of the prostate and with no cancer cells found in nearby lymph nodes) evaluated by PSMA PET scan.\n* Within 6 months prior to signing consent have had a multiparametric MRI.\n\n  1. mpMRI results must show localized disease meaning a single MRI region of suspicion (PI-RADS ≥3 with lesion volume ≤1.5 cc).\n  2. Maximum lesion diameter in any MRI dimension must be ≤11.9 mm.\n* Within 6 months prior to signing consent, have undergone a multiparametric MRI software guided fusion biopsy of the prostate (transrectal or transperineal)\n\n  1. Central Pathology confirmation showing a minimum of 2 cores in aggregate of pattern 4 disease (GG3) in the targeted lesion identified by Central Imaging\n  2. GG1 cores from anywhere in the prostate are acceptable\n  3. Less than 50% of systematic biopsy cores are positive for GGG 1 or 2 disease. For the \\\u003C50% calculation, all systematic positive cores located in the sector(s) containing the target, or in sectors immediately adjacent to the qualifying target, are counted as \"one core.\"\n* Within 6 months prior to signing consent have had a PSMA-PET scan.\n\n  1. PSMA-PET results show no suspicion of metastasis as determined by site read\n  2. Per Radiology Central Imaging, PSMA-PET scan prostate results are concordant with mpMRI results\n  3. If PSMA indicates a hotspot separate from the lesion or planned treatment area, a targeted repeat biopsy is required to rule out ≥ GG2\n* All positive GG2 or GG3 cores must be located in the lesion, or immediately adjacent to the lesion, as determined by pathology report and, if available, the fusion system's tracking, mapping and imaging documentation features.\n* Participant is willing and able to adhere to specific protocol visits and required testing throughout study.\n* Participant is geographically stable and near the site or able and willing to travel back to site for follow-up visits.\n* Participant is able and willing to provide written consent to participate in the study.\n* Participant is willing and able to receive ablative therapy within 90 days after signing consent.\n\nExclusion Criteria:\n\n* Participants with ≥GG4 cores anywhere in the prostate.\n* Participants with GG2 or GG3 cores outside the region of interest.\n* Contraindications per the Vanquish Instructions For Use.\n* Any previous treatment for prostate cancer or any prior surgery, intervention, or minimally invasive therapy (MIST) for the prostate or bladder neck, including but not limited to Vanquish therapy, TUIP, TURP, Aquablation, Green Light, Rezūm, Prostatic Urethral Lift, iTind, Prostatic Arterial Embolization, or microwave therapy.\n* Currently taking medications that have hormonal effects on the prostate or PSA, such as:\n\n  1. 5 alpha reductase inhibitors, if on for \\\u003C 6 months (6-month washout required if participant is able and willing to stop medication)\n  2. Androgen blockers,\n  3. Luteinizing hormone-releasing hormone (LHRH) agonists or antagonists within the past 12 months,\n  4. or Testosterone supplementation (3-month washout required) A participant on BPH medication which does not affect the PSA can be included.\n* Treated within the past 5 years for a lower and\u002For upper urinary tract malignancy.\n* Any cognitive or psychiatric condition that interferes with or precludes direct and accurate communication with the study Investigator regarding the study or affects the ability to complete the study quality of life questionnaires.\n* Participant currently participating in other prostate tissue and\u002For cancer study unless approved by Sponsor in writing.\n* Participant is considered vulnerable such as incarcerated or cognitively impaired.","50 Years",{"count":147,"type":21},[207],"The goal of this study is to evaluate the safety and effectiveness of the Vanquish Water Vapor Ablation System (\"Vanquish\") in participants with Grade Group 3 (GG3) intermediate-risk prostate cancer.\n\nParticipants will undergo therapy with the Vanquish System and complete follow up visits at 7 days, 6 weeks, 6 months, 12 months, 18 months, and 24 months.",[27],[637,638,27,639,640],"Vapor","Ablation","Grade Group 3","Water Vapor","2026-06-25",{"date":408,"type":33},{"date":439,"type":21},{"date":645,"type":21},"2028-09",{"name":647,"class":40},"Francis Medical Inc."]