[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-prostate-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-prostate-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,47,78,106,129,153,177,203,240,265,290,313,335],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100053341","phase-2-il-15-superagonist-with-or-without-vaccine-in-biochemically-recurrent-prostate-cancer-after-previous-stereotactic-body-radiation-therapy-100053341",false,"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.","MALE","18 Years","120 Years",{"count":20,"type":21},65,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","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.",[27,28],"Recurrent Prostate Cancer","Prostate Cancer",[27,30,31,32,33],"IL-15 Superagonist","N-803","ETBX-071","PSA Vaccine","NOT_YET_RECRUITING","2026-07-10",{"date":37,"type":38},"2026-07-13","ACTUAL",{"date":40,"type":21},"2026-07-16",{"date":42,"type":21},"2029-01-30",{"name":44,"class":45},"National Cancer Institute (NCI)","NIH",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":46},"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":55,"type":21},20,[24],"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).",[28,27,59,60,61],"Metastatic Prostate Cancer","Prostate Cancer Recurrent","Prostate Cancer Metastatic",[63,64,65,66,67],"Prostate cancer","Low PSA","PSMA PET","BCR","Bicalutamide","2026-06-29",{"date":70,"type":38},"2026-07-01",{"date":72,"type":21},"2026-07-31",{"date":74,"type":21},"2027-10-31",{"name":76,"class":77},"Washington University School of Medicine","OTHER",{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":86,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":22,"phases":89,"briefSummary":91,"conditions":92,"keywords":93,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":46},"100304716","partial-prostate-salvage-high-dose-rate-brachytherapy-100304716","NCT03246802","Partial Prostate Salvage High Dose Rate Brachytherapy","High Dose Rate Partial Prostate Brachytherapy as Salvage Treatment for Local Failures After Previous External Beam Radiotherapy","SalvageHDR","Inclusion Criteria:\n\n* Age \\>45 and Life expectancy \\>10 years\n* Previous External Beam Radiotherapy (EBRT) or LDR brachytherapy w\n* \\> 3 year interval since EBRT or LDR Brachytherapy\n* No late toxicity from prior EBRT ≥ grade 2\n* PSA \\> nadir + 2 ng\u002Fml and \\\u003C 10 ng\u002Fml\n* PSA Doubling time \\> 6 months\n* Radiographic evidence corresponding with site of recurrence in an under-dosed or untreated site. The recurrence should correspond to the site of original disease or be located in the seminal vesical +\u002F- adjacent prostate as only area of recurrence (i.e. unifocal recurrence).\n* Per Investigator, recurrence is suitable for implant with HDR brachytherapy and patient is suitable for procedure under anesthesia, spinal or general.\n* Negative staging of the abdomen\u002Fpelvis and bones.\n* Willing to provide informed consent\n\nExclusion Criteria:\n\n* Not compliant with criteria above\n* Unable to give informed consent","45 Years",{"count":88,"type":21},30,[90],"NA","A dose-response relationship for radiation in the management of prostate cancer is well established. Local recurrence of prostate cancer after external beam radiotherapy occurs in at least 40% of patients treated because of inability to deliver sufficient dose through external beam techniques. These patients respond well to re-irradiation using brachytherapy with about 50% of selected patients remaining free of recurrence 5 years after salvage. Advanced imaging using multiparametric Magnetic Resonance Imaging (mpMRI) allows identification of the site of recurrence, permitting partial prostate salvage brachytherapy. There is extensive literature on Low Dose Rate salvage brachytherapy but less on High Dose Rate.",[27],[94,95,96],"recurrent prostate cancer","mpMRI","salvage HDR brachytherapy","RECRUITING","2026-06-24",{"date":68,"type":38},{"date":101,"type":38},"2018-01-01",{"date":103,"type":21},"2037-01-01",{"name":105,"class":77},"British Columbia Cancer Agency",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":115,"phases":4,"briefSummary":116,"conditions":117,"keywords":118,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":46},"100462683","tumor-microenvironment-analysis-of-prostate-cancer-metastasis-100462683","NCT05304858","Tumor Microenvironment Analysis of Prostate Cancer Metastasis","Connecting Lineage Target Expression and Immune Tumor Microenvironment Analysis of Prostate Cancer Metastasis","Inclusion Criteria:\n\n* Be willing and able to provide written informed consent for the trial.\n* Age ≥18 years of age on day of signing informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status: 0,1 or 2\n* Histologically proven adenocarcinoma of the prostate. (Rarely pathology is not available but if clinical situation confirms prostate cancer - such as prior response to androgen ablation and\u002For metastatic disease typical of prostate cancer, i.e. involving bone or pelvic\u002Fextra pelvic lymph nodes or para-aortic lymph nodes, AND an elevated serum concentration of prostate-specific antigen (PSA) typical of prostate cancer) pathology is not required and patient can be enrolled after discussed with study PI.\n* Clinical stage N1 or M1\n* Evidence of nodal or distant metastasis by MRI\u002FCT scan, bone scan or positron emission tomography (PET) scan\n* Planned specimen from subjects that undergo core needle biopsy must allow for cores of at least 21 gauge with depth of 5 mm. A goal of 3-8 core specimens (3 to 8 passages of the needle into the lesion) will be sought during the procedure, if felt to be safe by the performing physician.\n* Laboratory tests meet minimum safety requirements:\n* Hemoglobin \\>7mg\u002FdL\n* Platelet count ≥75,000\u002Fmm3\n* Coagulation: prothrombin time (PT)\u002Finternational normalized ratio (INR), Partial thromboplastin time (PTT) ≤ 1.5 upper limit of normal (ULN) (except if on therapeutic anticoagulation in which case the patient can be enrolled if stable and anticoagulation levels are appropriate for their condition per good clinical practice).\n\nExclusion Criteria:\n\n* A psychiatric disorder, medical condition, or other life circumstance, which in the opinion of the investigators, would make it difficult for a patient to successfully complete the informed consent process.\n* Acute illness or any medical condition in the judgment of the study physician making specimen collection inadvisable",{"count":114,"type":21},16,"OBSERVATIONAL","The purpose of this study is to collect prostate cancer tissue from males with metastatic prostate cancers in order to study the tumor microenvironment (TME), which is the area surrounding the tumor including cells, blood vessels, etc., in men with metastatic prostate cancer. The type of research performed on these tissue samples include genetic \\& molecular analyses.",[27],[119,28],"Metastasis","2026-06-03",{"date":122,"type":38},"2026-06-05",{"date":124,"type":38},"2021-09-15",{"date":126,"type":21},"2028-02",{"name":128,"class":77},"Columbia University",{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":136,"targetDuration":4,"studyType":22,"phases":137,"briefSummary":138,"conditions":139,"keywords":141,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":46},"100523529","phase-2-enzalutamide-and-pds01adc-in-pet-positive-recurrent-prostate-cancer-pprpc-without-testosterone-lowering-therapy-100523529","NCT06096870","Enzalutamide and PDS01ADC in PET Positive Recurrent Prostate Cancer (pprPC) Without Testosterone Lowering Therapy","Phase II Trial of Enzalutamide and PDS01ADC in PET Positive Recurrent Prostate Cancer (pprPC) Without Testosterone Lowering Therapy","* INCLUSION CRITERIA:\n* Participant must provide documentation of histologic or cytological confirmation of prostate cancer or tumor sample for diagnosis confirmation. Note: in the absence of pathology or documentation, participant must have a rising PSA, PSMA+ disease, and his history consistent with prostate cancer as documented by the investigator.\n* History of primary treatment for prostate cancer (either surgery or radiation).\n* Prostate-specific antigen (PSA) doubling time within less than 12 months.\n* Testosterone \\>100 ng\u002FdL.\n* Age \\>=18 years.\n* Evidence of prostate cancer on PSMA PET\u002FCT scan.\n* Eastern Cooperative Oncology Group (ECOG) performance status \\\u003C2.\n* Men must agree to use an effective method of contraception (barrier or surgical sterilization) after study entry and for 3 months after completion of enzalutamide or PDS01ADC therapy whatever comes later.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * Absolute neutrophil count (ANC) \\>=1,500\u002Fmicroliter, without granulocyte colony-stimulating factor (G-CSF) support\n  * Platelets \\>=100,000\u002Fmicroliter\n  * Aspartate aminotransferase (AST) \u002FAlanine aminotransferase (ALT) \\\u003C=2.5 x institutional upper limit of normal (ULN)\n  * Hemoglobin (Hgb) \\>= 10 g\u002FdL (packed red blood cell (pRBC) transfusions are not allowed to achieve acceptable Hgb)\n  * Total bilirubin \\\u003C= 1.5 x ULN, OR \\\u003C= 3.0 ULN in participants with Gilbert s syndrome\n  * Serum albumin \\>= 2.8 g\u002FdL\n  * Creatinine \\\u003C 1.5 X institution ULN\n\nOR\n\n--Measured or calculated creatinine clearance (CrCl) (estimated glomerular filtration rate (eGFR) may also be used in place of CrCl) \\> 45 mL\u002Fmin\u002F1.73 m\\^2 for participant with creatinine levels \\> 1.5 x institutional ULN\n\n* Hepatitis B virus (HBV)-infected participants can be enrolled if HBV DNA is undetectable at screening. Hepatitis C virus (HCV)-infected participants can be enrolled if the HCV RNA level is undetectable at screening. Human immunodeficiency virus (HIV)-positive participants can be enrolled if HIV DNA is undetectable.\n* Participants must be able to swallow tablets\u002Fcapsules.\n* Participants must be able to understand and willing 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) if assessment cannot be done by CT scan) per RECIST 1.1 criteria (lymph nodes up to 2.0 cm in the shortest dimension are allowed).\n* Evidence of bone lesions on Tc99 bone scan.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study drugs or imaging agents used in the study.\n* Any medical condition that requires chronic systemic steroid therapy, or any other form of immunosuppressive medication (inhaled and topical steroids are permitted).\n* History of seizures within the last 10 years.\n* Therapy with strong inhibitors or inducers of CYP2C8 or CYP3A4 (https:\u002F\u002Fdruginteractions.medicine.iu.edu\u002FMainTable.aspx) within 5 half-lives prior to the study treatment initiation.\n* Participants with prior malignancy active within 3 years prior to study treatment initiation except for locally curable cancers that have been apparently cured such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the breast.\n* Uncontrolled intercurrent illness that would limit compliance with study requirements.",{"count":20,"type":21},[24],"Background:\n\nProstate cancer may return after treatment in 30,000 to 50,000 people each year. There is no clear best way to treat these people. Better treatments are needed.\n\nObjective:\n\nTo test a study drug (enzalutamide), both alone and combined with a second drug (PDS01ADC), in people with prostate cancer that returned after treatment.\n\nEligibility:\n\nPeople aged 18 years and older with prostate cancer that returned after treatment.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam, with blood tests. All their urine will be collected for 24 hours. They will have imaging scans of their chest, abdomen, pelvis, and bones. Their ability to perform everyday activities will be assessed. They may opt to give a stool sample.\n\nParticipants will be treated in 4-week cycles.\n\nEnzalutamide is a pill taken by mouth once a day, every day. All participants will be given a supply of this drug to take at home.\n\nPDS01ADC is injected under the skin once a month, on the first day of each cycle. Half of the participants will receive both drugs.\n\nAll participants will visit the clinic once a month. Each visit should last no more than 8 hours. Blood and urine tests will be repeated.\n\nAll participants will receive the study treatment for 3 cycles. Some participants may need 3 more cycles of treatment with enzalutamide only. This re-treatment can be done only once.\n\nParticipants will have a follow-up visit 1 month after they finish treatment. After that, they will have visits every 6 weeks for up to 5 years. Imaging scans and blood tests will be repeated.\n\n...",[28,27,140],"PET Positive",[142,27,140,143,144],"Combination Therapy","Enzalutamide","PDS01ADC","2026-05-30",{"date":147,"type":38},"2026-06-02",{"date":149,"type":38},"2024-04-22",{"date":151,"type":21},"2029-12-31",{"name":44,"class":45},{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":22,"phases":162,"briefSummary":164,"conditions":165,"keywords":4,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":176},"100290921","phase-1-clinical-study-to-assess-the-safety-and-efficacy-of-the-spectracure-p18-system-100290921","NCT03067051","Clinical Study to Assess the Safety and Efficacy of the SpectraCure P18 System","Open-label Clinical Study to Assess the Safety and Efficacy of the SpectraCure P18 System (Interstitial Multiple Diode Lasers and IDOSE® Software) and Verteporfin for Injection (VFI) for the Treatment of Recurrent Prostate Cancer","Phase 1 Inclusion Criteria:\n\n1. Males \\> 18 years who have gone through external or internal, high dose rate (brachy) radiation therapy for localized prostate cancer with histopathologically verified local recurrence.\n2. Prostate volume less than 50 cm3 defined by transrectal ultrasound\n3. Subject not eligible for surgery or curative radiotherapy\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n5. Expected survival ≥ 8 months\n6. Sufficient bone marrow reserve as indicated by; granulocyte count ≥ 1500\u002Fmm3, platelet count ≥ 100,000\u002Fmm3\n7. Adequate renal function as defined by creatinine ≤ 1.5 mg \u002Fdl\n8. Adequate hepatic function, based on a total bilirubin ≤ 1.5 mg\u002Fdl, serum glutamate-oxaloacetate transaminase (SGOT) ≤ 3 times the upper limit of normal, and alanine transaminase (ALT) ≤ 3 times the upper limit of normal\n9. Signed Informed Consent\n\nPhase 1 Exclusion Criteria:\n\n1. Patients with locally advanced (AJCC 7th edition T3\u002FT4) or metastatic disease\n2. Patients who have been treated with seed implantation brachytherapy\n3. Gleason score ≥ 8 at initial diagnosis\n4. Less than 1 week since surgery (excluding minimal procedures, e.g. vascular access device insertion)\n5. Concomitant infection\n6. Subjects with other severe concurrent disease that in the judgement of the investigator would make the subject inappropriate for entry into this study\n7. Mental incapacity or psychiatric illness that would interfere with the subject's ability to understand and give informed consent or to complete follow-up visits according to the judgement of the investigator\n8. Contraindication for photosensitizer\n9. Porphyria or other diseases exacerbated by light\n10. Known hypersensitivity to verteporfin for injection (VFI) or to any of the excipients\n11. Known allergies to porphyrins\n12. Tumours known to be eroding into a major blood vessel in or adjacent to the illumination site\n13. On-going therapy with a photosensitizing agent\n14. Enrolment in another therapeutic clinical study within 3 months prior to randomization and throughout the study.\n15. Subjects with a history of CTCAE v4 grade 3 or greater or persistent (\\>1 separate episode or symptoms lasting more than 3 months after initiation of medical intervention) grade 2 proctitis attributed to radiation.\n\nPhase 2 Inclusion Criteria:\n\n1. Subjects \\> 18 years who have gone through external or internal, high dose-rate (brachy) radiation therapy for localized prostate cancer with histopathologically verified local recurrence.\n2. Treatment target volume less than 50 cm3.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. Expected survival ≥ 12 months.\n5. Sufficient bone marrow reserve as indicated by; granulocyte count ≥ 1500\u002Fmm3, platelet count ≥ 100,000\u002Fmm3.\n6. Adequate renal function as defined by creatinine ≤ 1.5 mg \u002Fdl.\n7. Adequate hepatic function, based on a total bilirubin ≤ 1.5 mg\u002Fdl, serum glutamate- oxaloacetate transaminase (SGOT) ≤ 3 times the upper limit of normal, and alanine transaminase (ALT) ≤ 3 times the upper limit of normal.\n8. Signed Informed Consent.\n\nPhase 2 Exclusion Criteria:\n\n1. Subjects with locally advanced (AJCC 7th edition T3\u002FT4), regional pelvic lymph node metastasis, or metastatic disease defined by PSMA PET.\n2. Subjects who have been treated with seed implantation brachytherapy.\n3. Less than 1 week since surgery (excluding minimal procedures, e.g. vascular access device insertion).\n4. Concomitant infection.\n5. Subjects with other severe concurrent disease that in the judgement of the investigator would make the subject inappropriate for entry into this study.\n6. Mental incapacity or psychiatric illness that would interfere with the subject's ability to understand and give informed consent or to complete follow-up visits according to the judgement of the investigator.\n7. Contraindication for photosensitizer.\n8. Porphyria or other diseases exacerbated by light.\n9. Known hypersensitivity to verteporfin for injection (VFI) or to any of the excipients.\n10. Known allergies to porphyrins.\n11. Tumours known to be eroding into a major blood vessel in or adjacent to the illumination site.\n12. On-going therapy with a photosensitizing agent.\n13. Enrolment in another therapeutic clinical study within 3 months prior to randomization and throughout the study.\n14. Subjects with a history of CTCAE v4 grade 3 or greater or persistent (\\>1 separate episode or symptoms lasting more than 3 months after initiation of medical intervention) grade 2 proctitis attributed to radiation.\n15. Contraindication for MRI\u002FGadolinium contrast such as: implants, severe renal impairment (glomerular filtration rate \\[GFR\\] \\\u003C30 mL\u002Fmin\u002F1.73m2, or previous contrast reactions.\n16. On-going or planned hormone therapy.",{"count":161,"type":21},66,[163,24],"PHASE1","The rationale for the study is to obtain safety and efficacy data as well as to establish dose parameters for the SpectraCure P18 System with IDOSE®, with verteporfin for injection (VFI) as photosensitizer for the treatment of recurrent prostate cancer.",[27],"2026-04-27",{"date":168,"type":38},"2026-05-01",{"date":170,"type":38},"2017-03-21",{"date":172,"type":21},"2027-12-31",{"name":174,"class":175},"SpectraCure AB","INDUSTRY",4,{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":22,"phases":187,"briefSummary":188,"conditions":189,"keywords":4,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":202},"100545205","phase-2-stereotactic-body-radiation-therapy-plus-immediate-or-delayed-androgen-receptor-pathway-inhibitor-and-androgen-deprivation-therapy-or-salvage-radiation-therapy-for-the-treatment-of-prostate-cancer-divine-trial-100545205","NCT06378866","Stereotactic Body Radiation Therapy Plus Immediate or Delayed Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy or Salvage Radiation Therapy for the Treatment of Prostate Cancer, DIVINE Trial","MC230502 Dynamic Investigator Initiated Enterprise (DIVINE) in Prostate Cancer","DIVINE","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Disease characteristics:\n\n  * DEVIATE (Groups A and B only):\n\n    * Clinical confirmation of metachronous (metastatic) recurrent hormone-sensitive prostate cancer\n    * Five (5) or fewer metastases with at least one metastasis beyond the pelvis on advanced molecular and\u002For conventional imaging\n    * Serum testosterone \\> 100ng\u002FdL\n  * BRIO (Gropus C \\& D only):\n\n    * Prostate-specific antigen (PSA) between 0.2 and 1.5 ng\u002FmL with PSA above 0.2 on at least two consecutive measurements at least 5 days apart\n    * No local or metastatic recurrence apparent on advanced molecular imaging\n    * Serum testosterone \\> 100 ng\u002FdL\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2\n* Hemoglobin ≥ 8.0 g\u002FdL (obtained ≤ 15 days prior to registration)\n* Absolute neutrophil count (ANC) ≥ 1500\u002Fmm\\^3 (obtained ≤ 15 days prior to registration)\n* Platelet count ≥ 80,000\u002Fmm\\^3 (obtained ≤ 15 days prior to registration)\n* Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x upper limit of normal (ULN) ( ≤ 5 x ULN for patients with liver involvement) (obtained ≤ 15 days prior to registration)\n* Calculated creatinine clearance ≥ 30 ml\u002Fmin using the Cockcroft-Gault formula (obtained ≤ 15 days prior to registration)\n* Provide written informed consent\n* Ability to complete questionnaire(s) by themselves or with assistance\n* Willingness to provide mandatory blood specimens for correlative research\n* Willingness to provide tissue specimens for correlative research\n* Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)\n\nExclusion Criteria:\n\n* Any of the following because this study involves an investigational agent, the genotoxic, mutagenic, and teratogenic effects of which on the developing fetus and newborn are unknown\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential or able to father a child who are unwilling to employ adequate contraception\n* Prior metastasis-directed therapy\n* Any of the following prior therapies:\n\n  * Surgery ≤ 3 weeks prior to registration\n  * Chemotherapy for prostate cancer at any time\n  * Androgen receptor pathway inhibitor such as abiraterone, apalutamide, darolutamide, or enzalutamide in the last 2 years\n* Uncontrolled intercurrent non-cardiac illness including, but not limited to:\n\n  * Ongoing or active infection\n  * Psychiatric illness\u002Fsocial situations\n  * Dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy\n  * Any other conditions that would limit compliance with study requirements\n* Receiving any other investigational agent which would be considered as a treatment for prostate cancer.\n* Failure to recover from acute, reversible effects of prior therapy regardless of interval since last treatment EXCEPTION: Grade 1 peripheral (sensory) neuropathy that has been stable for at least 3 months since completion of prior treatment\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * Ongoing or active infection\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Cardiac arrhythmia\n  * Or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm\n* Other active malignancy ≤ 3 years prior to registration\n\n  * EXCEPTIONS: Curatively treated non-melanotic skin cancer or papillary thyroid cancer\n  * NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment such as chemotherapy or antihormonal therapy for their cancer\n* History of myocardial infarction ≤ 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias",{"count":186,"type":21},532,[24],"This phase II trial studies the effects of stereotactic body radiation therapy (SBRT) and the timing of treatment with androgen receptor pathway inhibitor (ARPI) plus androgen deprivation therapy (ADT) in treating patients with hormone sensitive prostate cancer that has spread from where it first started to other places in the body (metastatic), and that has come back after a period of improvement (recurrent). It also studies the effects of salvage radiation therapy (sXRT) on prostate cancer and to see if radiation to the pelvis helps prevent prostate cancer from spreading elsewhere. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Androgen can cause the growth of prostate cells. ADT lowers the amount of androgen made by the body. This may help stop the growth of tumor cells that need androgen to grow. Androgen receptor pathway inhibitors work by blocking the effects of androgen to stop the growth and spread of tumor cells. sXRT is a targeted radiation treatment for the prostate, typically given when cancer possibly returns after surgery or radiation. Its goal is to destroy any tumor cells in the area. Giving SBRT alone with watchful waiting may be as effective in treating prostate cancer as giving SBRT together with ARPI and ADT and sXRT may be effective in treating prostate cancer and preventing it from spreading elsewhere.",[190,27,191,192],"Recurrent Castration-Sensitive Prostate Carcinoma","Castration-resistant Prostate Cancer","Biochemically Recurrent Prostate Carcinoma","2026-04-17",{"date":195,"type":38},"2026-04-20",{"date":197,"type":38},"2024-06-03",{"date":199,"type":21},"2031-02-28",{"name":201,"class":77},"Mayo Clinic",3,{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":209,"eligibilityCriteria":210,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":211,"targetDuration":4,"studyType":22,"phases":213,"briefSummary":215,"conditions":216,"keywords":220,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":55},"100422969","phase-2-veterans-affairs-seamless-phase-iiiii-randomized-trial-of-standard-systemic-therapy-with-or-without-pet-directed-local-therapy-for-oligometastatic-prostate-cancer-100422969","NCT04787744","Veterans Affairs Seamless Phase II\u002FIII Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer","Veterans Affairs Seamless Phase II\u002FIII Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for OligoRecurrenT Prostate Cancer (VA STARPORT)","VA STARPORT","Inclusion Criteria:\n\nAge 18 years. Ability to provide Informed Consent for participation in the study ECOG Performance Status 2 at time of enrollment. Prostate cancer, confirmed histologically or cytologically. If original documentation of histology and cytology are not available, documentation of prostate cancer satisfies these criteria. If recurrent, prior curative-intent local therapy to all sites of prostate cancer with either upfront radiotherapy or prostatectomy with or without post-operative radiotherapy.\n\nIf recurrent, PSA suspicious for biochemical recurrence after local therapy, with lab value(s) taken prior to start of SST (if current SST has already started) or within 90 days prior to enrollment if not already on SST, and meeting one of the three below categories:\n\nPSA 0.2 ng\u002Fml x 2 after prostatectomy +\u002F- post-operative radiotherapy; Elevation of PSA 2 ng\u002Fml above the nadir after definitive radiotherapy; Or Two consecutively elevated PSAs with evidence of metastasis on the imaging Studies.\n\n-Serum testosterone obtained prior to randomization based on one of the criteria below:\n\nFor patients who have a history of a prior episode of therapy with SST agents for prostate cancer, a total testosterone 100 ng\u002Fdl after completion of the prior episode of SST and before the start of current SST or within 30 days of starting current SST if the patient has already started SST for recurrence.\n\nFor patients who have no prior history of an episode of therapy with SST agents and have already started SST for recurrence, this pre-SST testosterone is not required.\n\nCT or MRI abdomen\u002Fpelvis performed prior to start of SST (if current SST has already started) or within 90 days prior to enrollment if not already on SST. The results from the CT component of the PET\u002FCT can be used to fulfill this criterion. This is optional for patients who have a PSMA PET\u002FCT. Yechnetium (Tc99m-MDP) or sodium fluoride (NaF) bone scan (sodium fluoride preferred) performed prior to start of SST (if current SST has already started), or within 90 days prior to enrollment if not already on SST. This is optional for patients who have a PSMA PET\u002FCT. Prostate PET\u002FCT (currently PSMA, Fluciclovine, choline) performed prior to start of SST (if current SST has already started), or within 90 days prior to enrollment if not already on SST.\n\n1-10 lesions suspicious for nodal recurrence or metastasis from prostate cancer as determined by the investigator based on the above imaging studies.\n\nHas already undergone NPOP sequencing or a plan is in place for NPOP sequencing for prostate cancer.\n\nFor participants on SST at the time of enrollment only:\n\nHas been on SST for 180 days. For participants with local recurrence after curative-intent local therapy on imaging :\n\nPatients with local recurrence in the prostate, SV, or prostate bed are eligible as long as there is at least 1 nodal or distant metastatic recurrence. Biopsy must confirm local recurrence for patients who have had prior curative-intent radiation to the prostate, SV, or prostate bed.\n\nCandidate for salvage local therapy (refer to Section 10.4) as determined by a urologist or radiation oncologist (depending on the respective modality to be used to treat the local recurrence).\n\nFor participants with de novo prostate cancer:\n\nCandidate for prostate-directed radiation.\n\nExclusion Criteria:\n\n* Any current or prior evidence of castration-resistant prostate cancer, defined as two consecutive rises in serum PSA, obtained at a minimum of 1-week interval, with the final PSA value \\>\u002F= 1 ng\u002Fml, while having a total testosterone \\\u003C 50 ng\u002Fdl).\n* Prior malignancy, except the following:\n\n  * Adequately treated non-melanomatous skin cancer;\n  * Adequately treated Stage 0, I, or II cancer from which the patient is currently in complete remission; or\n  * Any other cancer from which the patient has been disease free for three years.\n* Presence of a symptomatic metastasis that requires palliative radiotherapy.\n* Any known brain metastases, presence of leptomeningeal disease, malignant spinal cord compression, or malignant cauda equina syndrome.\n* Prior nodal, bone, or visceral metastasis after curative-intent therapy other than those identified on the enrollment imaging studies which make the patient ineligible for PET-directed local therapy (per investigator discretion).\n* Prior radiation therapy to any sites requiring PET-directed local therapy or salvage local therapy that will lead to prohibitively high risk of toxicity from subsequent local therapy, as determined by the treating radiation oncologist (if radiation is intended as the study local therapy) or surgeon\u002Furologist (if surgery is intended as the study local therapy).\n* Any other previous or current condition, which, in the judgement of the LSI, is likely to interfere with any STARPORT treatments or assessments.",{"count":212,"type":21},464,[24,214],"PHASE3","This is a prospective, open-label, multi-center seamless phase II to phase III randomized clinical trial designed to compare SST with or without PET-directed local therapy in improving the castration-resistant prostate cancer-free survival (CRPC-free survival) for Veterans with oligometastatic prostate cancer. Oligometastasis will be defined as 1-10 sites of metastatic disease based on the clinical determination of the LSI which incorporates all imaging, clinical, and pathologic data available.",[28,217,218,27,59,219],"Oligometastasis","Oligorecurrence","De Novo Prostate Cancer",[28,119,218,221,222,223,217,224,225,226,27,227,228,229],"PET-directed local therapy","Standard Systemic Therapy","SBRT","Oligorecurrent","Metastasis-directed therapy","Salvage Local Therapy","Fluciclovine","PSMA","Choline","2026-04-02",{"date":232,"type":38},"2026-04-08",{"date":234,"type":38},"2021-07-01",{"date":236,"type":21},"2029-03-30",{"name":238,"class":239},"VA Office of Research and Development","FED",{"id":241,"slug":242,"hasResults":11,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":4,"eligibilityCriteria":246,"healthyVolunteers":11,"sex":16,"minAge":247,"maxAge":18,"enrollmentInfo":248,"targetDuration":4,"studyType":22,"phases":250,"briefSummary":251,"conditions":252,"keywords":254,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":4},"100615314","alpha-radiation-emitters-device-dart-for-the-treatment-of-locally-recurrent-prostate-cancer-100615314","NCT07290998","Alpha Radiation Emitters Device (DaRT) for the Treatment of Locally Recurrent Prostate Cancer","A Safety Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Locally Recurrent Prostate Cancer","Inclusion Criteria:\n\n* Histologically and\u002For cytologically proven prostate adenocarcinoma\n* Biochemical recurrence by the Phoenix definition (PSA nadir + 2 ng\u002FmL) and confirmed by a pre-treatment biopsy.\n* Patients eligible for focal salvage brachytherapy\n* Clinical stage T1-T2 on relapse; unilateral extracapsular extension (T3a) on MRI permitted except posteriorly relative to the rectum\n* Pre-salvage PSA level (rPSA) \\\u003C 10 ng\u002Fml\n* Target lesion is technically amenable for Alpha DaRT sources implantation.\n* Targetable lesion by either PSMA PET-CT according to PERCIST v1.0 OR by multiparametric MRI according RECIST v1.1 (Patients who were classified as stage II according to MRI)\n* Lesion size ≤ 5 cm in the longest diameter\n* ECOG Performance Status Scale 0 - 2\n* Life expectancy is more than 6 months\n* WBC ≥ 3500\u002Fµl, granulocyte ≥ 1500\u002Fµl\n* Platelet count ≥60,000\u002Fµl\n* Creatinine ≤1.9 mg\u002FdL\n* AST and ALT ≤ 2.5 X upper limit of normal (ULN)\n* INR \\\u003C 1.4 for patients not on Warfarin\n* Age ≥ 40 years old\n* Subjects are willing and able to sign an informed consent form\n* Patients must agree to use adequate contraception (vasectomy or barrier method of birth control) for 3 months after DaRT insertion\n\nExclusion Criteria:\n\n* Concomitant immunotherapy within the past 4 weeks.\n* Patients with lymph node or metastatic disease\n* Known hypersensitivity to any of the components of the treatment.\n* Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.\n* Patients with prior surgery or low-dose-rate (LDR) brachytherapy as the primary treatment of their prostate cancer.\n* \\[For Stage 1 of the study only\\] Patients with prior high-dose-rate (HDR) brachytherapy or stereotactic body radiation therapy (SBRT) as the primary treatment of their prostate cancer.\n* Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.\n* Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trial or interfere with the study endpoints.\n* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy, low risk prostate cancer, or in situ cervical cancer.\n* Patient requires treatment not specified in this protocol which may conflict with the endpoints of this study including evaluation of response or toxicity of DaRT.\n* Patients do not agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation, and for 3 months after DaRT insertion\n* Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT.\n* High probability of protocol non-compliance (in opinion of investigator).","40 Years",{"count":249,"type":21},12,[90],"This is a multi-center clinical study enrolling up to 12 participants . The primary objective of the study is to evaluate the safety of Alpha DaRT for the treatment of locally recurrent prostate cancer . The secondary objectives of the study is to evaluate the efficacy of the Alpha DaRT sources in locally recurrent prostate cancer patients assessed by biochemical and clinical evaluation of disease progression as well as overall survival",[28,27,253],"Locally Recurrent Prostate Cancer",[255,28,27],"Alpha radiation","2026-03-31",{"date":258,"type":38},"2026-04-06",{"date":260,"type":21},"2026-05",{"date":262,"type":21},"2029-05",{"name":264,"class":175},"Alpha Tau Medical LTD.",{"id":266,"slug":267,"hasResults":11,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":271,"eligibilityCriteria":272,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":273,"targetDuration":4,"studyType":22,"phases":275,"briefSummary":276,"conditions":277,"keywords":278,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":284,"completionDateStruct":285,"leadSponsor":287,"locationsCount":289},"100621038","phase-2-terbinafine-for-biochemically-recurrent-prostate-cancer-terbinapro-100621038","NCT07365423","Terbinafine for Biochemically Recurrent Prostate Cancer (TerbinaPro)","Terbinafine for Biochemically Recurrent Prostate Cancer (TerbinaPro) - A Phase II Drug-repurposing Study","TerbinaPro","Key Inclusion Criteria:\n\n* Patients after definitive treatment for localized prostate cancer and exhaustion of standard curative options (i.e. after prostatectomy and adjuvant \u002Fsalvage radiotherapy; definite radiotherapy, brachytherapy; additional previous Stereotactic Body Radiation Therapy (SBRT) to treat visible oligometastatic disease also allowed as long as confirmed Prostate-specific antigen (PSA) progression is present after SBRT)\n* Non-castrate levels of testosterone (≥ 5 nmol\u002Fl; previous androgen deprivation therapy (ADT) allowed as long as testosterone levels have recovered before study entry)\n* No evidence of distant metastatic disease on conventional imaging (Computed Tomography (CT) and bone scan) or Prostate-Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET) CT.\n* Patients with PSMA positive lymph nodes on PSMA PET CT can still be included if the short axis of the largest lymph node is \\\u003C 20 mm for lymph nodes below aortic bifurcation or \\\u003C 10 mm above the aortic bifurcation.\n* PSA of ≥1 ng\u002Fml after radical prostatectomy or ≥2 ng\u002Fml above the nadir (with recovered testosterone) after primary radiotherapy; confirmation of rising PSA in at least a second measurement at least 2 weeks apart\n* Patient declining start of ADT and \u002For an androgen receptor pathway inhibitor (ARPI) and\u002For judged as not in need of immediate ADT\u002FARPI start by treating physician\n\nKey Exclusion Criteria:\n\n* Pre-existing known chronic or acute liver disease\n* Known history of systemic lupus erythematosus or any form of lupus (including cutaneous, drug-induced, or lupus nephritis)\n* Pure neuroendocrine\u002Fsmall-cell histologic variant of prostate cancer",{"count":274,"type":21},42,[24],"TerbinaPro is a phase II drug-repurposing study evaluating oral Terbinafine in patients with biochemical recurrence of prostate cancer after prior local treatment with curative intent. When local salvage strategies have been exhausted, recurrence usually reflects micro-metastatic disease without clearly visible metastases on imaging. Standard therapy with androgen deprivation or androgen-receptor pathway inhibitors can effectively control disease but is associated with substantial side effects and negative impact on quality of life. Terbinafine is a long-licensed, generic antifungal drug that inhibits squalene epoxidase (SQLE), an enzyme that may play a role in prostate cancer progression. Preclinical and limited clinical data suggest potential anti-cancer activity.",[27],[94,279,280,281],"Terbinafine","phase II","drug-repurposing Study","2026-03-27",{"date":230,"type":38},{"date":260,"type":21},{"date":286,"type":21},"2030-10",{"name":288,"class":77},"Swiss Cancer Institute",11,{"id":291,"slug":292,"hasResults":11,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":4,"eligibilityCriteria":296,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":297,"targetDuration":4,"studyType":22,"phases":299,"briefSummary":300,"conditions":301,"keywords":4,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":311,"locationsCount":46},"100599873","phase-1-trial-of-ptvg-hpnivotargeted-ablation-of-resistant-lesions-in-non-castrate-recurrentompc-100599873","NCT07090148","Trial of pTVG-HP+Nivo+Targeted Ablation of Resistant Lesions in Non-Castrate RecurrentOMPC","Pilot Trial of a DNA Vaccine Encoding Prostatic Acid Phosphatase (pTVG-HP) and PD-1 Blockade, With Targeted Ablation of Resistant Lesions, in Patients With Non-Castrate Recurrent Oligometastatic Prostate Cancer","Inclusion Criteria:\n\n* Participants must be at least 18 years of age with a histologic diagnosis of adenocarcinoma of the prostate\n* Participants must have undergone radical prostatectomy\n* Participants must have completed local therapy by surgery, and any adjuvant\u002Fsalvage radiation therapy (if required), at least 3 months prior to entry, with removal or ablation of all visible disease, including seminal vesical and\u002For local lymph node involvement.\n* Participants must have biochemically recurrent disease defined by the following:\n\n  * PSA doubling time, calculated from most recent 4 serum PSA values (collected up to one year prior to enrollment, at least 2 weeks apart, and all from the same clinical laboratory), must be a positive number (i.e. evidence of PSA rise over time).\n* Participants must have oligometastatic disease, defined as:\n\n  * \\\u003C 3 lesions consistent with metastases as detected by CT of the abdomen\u002Fpelvis and bone scintigraphy (bone scan)\n  * Lesions consistent with metastatic prostate cancer as detected by PSMA PET\u002FCT\n* Participants with a prior history of a second malignancy are eligible provided they have been treated with curative intent and have been free of disease greater than three years. There will be no exclusion for patients with a history of basal cell carcinoma, squamous cell skin cancer, superficial bladder cancer, or other in situ carcinoma that has been adequately treated.\n* Participants who are sexually active must use a reliable form of contraception while on study and for 4 weeks after the last immunization.\n* ECOG performance score \\\u003C 2 and life expectancy of at least 12 months.\n* Participants must have normal hematologic, renal and liver function\n* Participants must be informed of the experimental nature of the study and its potential risks and must sign an IRB-approved written informed consent form indicating such an understanding.\n* Willingness to provide blood samples for immune studies, per study calendar, up to one year after study, even if off treatment.\n\nExclusion Criteria:\n\n* Small cell or other variant prostate cancer histology\n* Participants cannot have evidence of immunosuppression or have been treated with immunosuppressive therapy, such as chemotherapy or chronic treatment dose corticosteroids (greater than the equivalent of 10 mg prednisone per day), within 3 months of the first vaccination.\n* Seropositive for HIV, hepatitis B (HBV) or hepatitis C (HCV) per patient history due to the immunosuppressive features of these diseases.\n* Prior treatment with an LHRH agonist or nonsteroidal antiandrogen, except in the following circumstances: Neoadjuvant\u002Fadjuvant androgen deprivation therapy administered with radiation therapy or at the time of prostatectomy is acceptable, provided that there was no evidence of PSA progression while on treatment. In this situation, patients must not have received more than 24 months of androgen deprivation treatment. Other treatment with androgen deprivation therapy is prohibited.\n* Serum testosterone at screening \\\u003C 50 ng\u002FdL.\n* Participants must not be concurrently taking other medications or supplements with known hormonal effects, including PC-SPES, megestrol acetate, finasteride, ketoconazole, estradiol, or Saw Palmetto. All other medications with possible anti-cancer effects must be discussed with the PI prior to study entry.\n* Participants previously treated with other potential or experimental therapies for prostate cancer must have discontinued these treatments and completed at least a 4 week washout prior to beginning treatment.\n* Participants must not have known psychological or sociological conditions, addictive disorders or family problems, which would preclude compliance with the protocol.\n* Participants with unstable or severe intercurrent medical conditions or laboratory abnormalities that would impart, in the judgment of the PI, excess risk associated with study participation or study agent administration.\n* Participants who have concurrent enrollment on other phase I, II, or III investigational therapeutic treatment studies for prostate cancer cannot be actively receiving treatment and the last dose cannot be within 4 weeks of day 1. They must be in the follow up phase of the study.",{"count":298,"type":21},14,[163],"The goal of this clinical trial is to learn whether an experimental vaccine called pTVG-HP (\"vaccine\" or \"DNA vaccine\"), combined with a drug called nivolumab can increase the cancer-fighting ability of a person's immune cells.\n\nThe main question it aims to answer is whether the combination of medicines can get rid of metastatic tumors in participants with non-castrate, recurrent, oligometastatic prostate cancer.\n\nParticipants will undergo:\n\n* Treatment with pTVG-HP\n* Treatment with Nivolumab\n* Radiation Therapy",[302,303,27,304],"Prostate Cancer Patients","Non-castrate Prostate Cancer","Oligometastatic Prostate Cancer (OMPC)","2026-03-09",{"date":307,"type":38},"2026-03-11",{"date":309,"type":38},"2026-03-03",{"date":286,"type":21},{"name":312,"class":77},"University of Wisconsin, Madison",{"id":314,"slug":315,"hasResults":11,"nctId":316,"briefTitle":317,"officialTitle":318,"acronym":4,"eligibilityCriteria":319,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":320,"targetDuration":4,"studyType":22,"phases":322,"briefSummary":323,"conditions":324,"keywords":325,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":328,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":333,"locationsCount":46},"100323782","phase-2-psma-pet-imaging-for-detecting-early-metastatic-prostate-cancer-in-men-w-high-decipher-test-scores-100323782","NCT03495427","PSMA-PET Imaging for Detecting Early Metastatic Prostate Cancer in Men w\u002F High Decipher Test Scores","The Utility of PSMA-PET Imaging for Detecting Early Metastatic Prostate Cancer in Men With High GC Decipher® Test Scores: A Sub-aim of the VANDAAM Study (MCC #18523)","Inclusion Criteria:\n\n* This study will enroll 60 patients previously enrolled to MCC#18523, \"A Validation Study on the Impact of Decipher® Testing on Treatment Recommendations in African-American and Non-African American Men with Prostate Cancer: (VANDAAM)\" that had high risk Decipher test results (Decipher score \\>0.45).\n* Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1\n* Previously enrolled to MCC#18523\n* Genomic Classifier (GC) testing successfully completed on biopsy and\u002For surgical specimen\n* Decipher score from participation on the MCC#18523 study meets the criteria for high-risk (\\>0.45)\n* Treated with radical prostatectomy (RP) or radiation therapy (RT) (+\u002F- short-term androgen deprivation therapy (ADT)) with ≥2 years follow up\n* Age \\> 18\n\nExclusion Criteria:\n\n* No follow up information available post treatment\n* Unable to undergo PET imaging due to pre-existing comorbidities and\u002For claustrophobia\n* Administration of any radioisotope within 5 physical half-lives OR any IV X-ray contrast medium within 24 hours OR any high-density oral contrast medium (oral water contrast acceptable) within 5 days prior to study drug injection",{"count":321,"type":21},60,[24,214],"This study will enroll 60 patients previously enrolled to MCC#18523, \"A Validation Study on the Impact of Decipher® Testing on Treatment Recommendations in African-American and Non-African American Men with Prostate Cancer: (VANDAAM)\" that had high risk Decipher test results (Decipher score \\>0.45). Patients with a high genomic classifier (GC) score at diagnosis will be approached for formal consenting for PSMA-PET imaging at 2 years post treatment.",[28,27],[326],"radioactive diagnostic imaging","2026-02-26",{"date":329,"type":38},"2026-03-02",{"date":331,"type":38},"2019-12-18",{"date":262,"type":21},{"name":334,"class":77},"H. Lee Moffitt Cancer Center and Research Institute",{"id":336,"slug":337,"hasResults":11,"nctId":338,"briefTitle":339,"officialTitle":340,"acronym":4,"eligibilityCriteria":341,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":342,"targetDuration":4,"studyType":115,"phases":4,"briefSummary":344,"conditions":345,"keywords":346,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":46},"100521490","determining-patterns-in-trial-experiences-of-recurrent-prostate-cancer-patients-100521490","NCT06070272","Determining Patterns In Trial Experiences of Recurrent Prostate Cancer Patients","Investigating the Dynamics of Patient Engagement and Trends in Participation in Recurrent Prostate Cancer Clinical Trials","Inclusion Criteria:\n\n* Patient is at least 18 years of age\n* Diagnosis of recurrent prostate cancer\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Enrolled in another research study\n* Patients with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Inability to provide written informed consent",{"count":343,"type":21},500,"Clinical studies, with a dedicated focus on recurrent prostate cancer, play a pivotal role in evaluating the safety and effectiveness of novel treatments for this condition.\n\nThese trials serve as essential tools to determine whether new medications outperform traditional therapies, providing substantial evidence to endorse their broader utilization.\n\nIt will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future patients with recurrent prostate cancer.",[27],[27],"2023-09-30",{"date":349,"type":38},"2023-10-06",{"date":351,"type":21},"2024-10",{"date":353,"type":21},"2026-10",{"name":355,"class":175},"Power Life Sciences Inc."]