[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"localized-prostate-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:localized-prostate-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,46,78,104,126,162,191,223,244,262,287],{"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":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100451172","phase-2-18f-dcfpyl-imaging-as-a-method-to-assess-treatment-response-to-stereotactic-body-radiation-therapy-100451172",false,"NCT05155046","18F-DCFPyL Imaging as a Method to Assess Treatment Response to Stereotactic Body Radiation Therapy","Phase II Trial of 18F-DCFPyL Imaging as a Method to Assess Treatment Response to Stereotactic Body Radiation Therapy","* INCLUSION CRITERIA:\n* Biopsy proven localized prostate cancer in whom stereotactic body radiation treatment (SBRT) with or without neoadjuvant androgen deprivation therapy (ADT) is planned for definitive management (NIH laboratory of pathology confirmation is not required).\n* Must have at least 1 MRI detected, biopsy proven localized prostate cancer.\n* Age \\>= 18 years\n* ECOG performance status \\\u003C= 2\n* For individuals with evidence of human immunodeficiency virus (HIV) infection, individuals must be on effective anti-retroviral therapy with undetectable viral load within the prior 6 months are eligible.\n* For individuals with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* For individuals with a history of hepatitis C virus (HCV), the infection must have been treated and cured. For individuals with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Ability of subject to understand and the willingness to sign a written informed consent document.\n* Men must agree to use adequate contraception with their partner (hormonal or barrier method of birth control; abstinence) for the duration of study participation and 2 months after the last 18F-DCFPyL scan.\n\nEXCLUSION CRITERIA:\n\n* Receiving prior androgen deprivation therapy, radiotherapy, or surgery for prostate cancer.\n* Any condition that is likely to interfere with study procedures or results.\n* Individuals in whom pelvic nodal irradiation is planned.\n* Serum creatinine \\> 2 times the upper limit of normal.\n* Weighing \\> 350 lbs (weight limit for scanner table), or unable to fit in imaging gantry.\n* Evidence of tumor spread beyond the prostate\u002Fseminal vesicles (lymph nodes, metastases).\n* Contraindications to radiation or SBRT.","MALE","18 Years","120 Years",{"count":20,"type":21},130,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Background:\n\nIdentifying medium- and high-risk prostate cancer early may allow for treatments to work. But identification can be hard. Researchers want to see if a radiotracer used during PET scans can help.\n\nObjective:\n\nTo test how an imaging agent called 18F-DCFPyL detects response to standard prostate cancer treatment.\n\nEligibility:\n\nPeople ages 18 and older with newly diagnosed prostate cancer who have no evidence of distant metastatic disease and plan to get stereotactic body radiation therapy (SBRT) with or without androgen deprivation therapy (ADT).\n\nDesign:\n\nParticipants will be screened with:\n\nMedical history\n\nPhysical exam\n\nBlood tests\n\nMRI\n\nParticipants will have baseline MRI and PET\u002FCT scans. For the MRI, they may get a contrast agent by IV injection. For the PET\u002FCT scan, they will get an IV injection of 18FDCFPyL. About 1 to 2 hours later, they will get the PET\u002FCT scan. During the scans, participants will lie on their back and remain still for 45 minutes to 1 hour. These scans will be repeated at different points during the study.\n\nParticipants will get SBRT with or without ADT.\n\nParticipants will complete questionnaires about their quality of life.\n\nParticipants will be asked about any symptoms they are having. They will also be asked about medications they are using. They may have a physical exam.\n\nParticipants will give blood and urine samples. They will give a tumor sample from a biopsy they have had in the past.\n\nAfter treatment, participants will have follow-up visits. These will occur 1 month after treatment, then every 3 months for a year, and then every 6 months for 1 more year.",[27],"Localized Prostate Cancer",[27,29,30,31,32],"Radiotherapy","Prostate Specific Membrane Antigen","Androgen Deprivation Therapy","longitudinal quality of life","RECRUITING","2026-06-23",{"date":36,"type":37},"2026-06-24","ACTUAL",{"date":39,"type":37},"2022-08-31",{"date":41,"type":21},"2029-12-31",{"name":43,"class":44},"National Cancer Institute (NCI)","NIH",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100643140","water-iv-pca-as-sub-study-100643140","NCT07650448","WATER IV PCa (AS Sub-study)","WATER IV Prostate Cancer: Aquablation Versus Active Surveillance for the Treatment of Localized Prostate Cancer","Inclusion Criteria:\n\n1. Biological male with age ≥ 45 years at the time of consent\n2. Biopsy positive Grade Group 2 prostate cancer or biopsy positive Grade Group 1 MRI visible lesion (PI-RADS\u002FLikert ≥ 3)\n3. First prostate cancer diagnoses within 18 months (545 days) of consent\n4. Are candidates for active surveillance\n5. Clinical Stage ≤ T2c\n6. PSA \\\u003C 15 ng\u002Fml\n7. Prostate volume ≥25 ml\n\nExclusion Criteria:\n\n1. Any prior or current local or systemic treatment for prostate cancer, including but not limited to surgery, radiation therapy (external or brachytherapy), tissue ablation, hormone therapy or chemotherapy.\n2. Patients with previous surgical or minimally invasive treatment of benign prostatic hyperplasia within the prior 3 months of study treatment.\n3. Evidence of lymph node, bone metastasis, extracapsular extension or seminal vesicle invasion.\n4. Patient is unwilling to accept a blood transfusion if required.\n5. Any condition or history of illness or surgery that may pose an additional risk to patients undergoing the Aquablation or radical prostatectomy procedure such as:\n\n5a. Medical conditions that preclude the use of anesthesia; 5b. Any condition or history of active rectal inflammatory bowel disease or other factors which might increase the risk of rectal injury (i.e. fistula formation); 5c. Patient is unable to stop anticoagulants or antiplatelet agents prior to study treatment per standard of care; 5d. Any other condition or history of infection, illness or surgery that in the opinion of the investigator might affect the outcome of the study procedure, study conduct, and study results; or pose additional risks to the patient (e.g., other cancer, active urethral stricture disease).\n\n6\\. Patients who are unable to provide informed consent due to cognitive impairment, legal status (such as incarceration), or other factors limiting autonomy or unwilling or unable to follow study instructions including randomization and complete all required study visits through 10 years. This includes individuals with severe cognitive disabilities, those under legal guardianship, or those currently incarcerated.\n\n7\\. Patient currently participating in other studies unless approved by Sponsor in writing.\n\n8\\. More than one complete biopsy beyond the diagnostic biopsy comprising both a systematic biopsy and biopsy of any MRI visible lesion (PI-RADS\u002FLikert ≥ 3).\n\n9\\. GG2 disease with PSA ≥ 10 OR stage ≥ T2b OR ≥ 50% of biopsy cores positive (multiple cores taken from any MRI visible lesion are counted as one continuous core).","45 Years",{"count":55,"type":21},333,[57],"NA","The WATER IV study is a multicenter, prospective, randomized clinical trial that aims to evaluate the safety and efficacy of Aquablation therapy in men with localized prostate cancer.",[27],[61,62,63,64,65,66],"Aquablation","AquaBeam","HYDROS","Active Surveillance","Prostate Cancer","Aquablation Therapy","NOT_YET_RECRUITING","2026-06-18",{"date":34,"type":37},{"date":71,"type":21},"2026-09",{"date":73,"type":21},"2038-12",{"name":75,"class":76},"PROCEPT BioRobotics","INDUSTRY",17,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":103},"100348780","phase-2-neoadjuvant-atezolizumab-based-combination-therapy-in-men-with-localized-prostate-cancer-prior-to-radical-prostatectomy-100348780","NCT03821246","Neoadjuvant Atezolizumab-Based Combination Therapy in Men With Localized Prostate Cancer Prior to Radical Prostatectomy","An Open-Label Multi-Center Phase II Study of Neoadjuvant Atezolizumab-Based Combination Therapy in Men With Localized Prostate Cancer Prior to Radical Prostatectomy","Inclusion Criteria:\n\n1. Histologically confirmed adenocarcinoma of the prostate.\n\n   a. Subjects with small cell or neuroendocrine PC are not eligible.\n2. Eligible for radical prostatectomy as determined by urologic oncology surgeon, and subject consents to proceeding with radical prostatectomy.\n\n   a. Deemed by urologic oncology surgeon to be appropriate for a \"window-of-opportunity\"study.\n3. Only patients with high-risk disease are eligible for the safety lead-in for each cohort. Patients with intermediate-risk disease will be included after interim analyses is complete for the corresponding cohort and the PI has determined that it is safe to do so.\n4. Availability of a representative tumor specimen that is suitable for the planned study analyses, as determined by the Principal Investigator.\n\n   1. A formalin-fixed paraffin-embedded (FFPE) tumor specimen in a paraffin block (preferred) or at least 15 slides containing unstained, freshly cut, serial sections should be submitted along with an associated pathology report prior to study treatment. If only 10-14 slides are available, the patient may still be eligible for the study, after Principal Investigator approval has been obtained.\n   2. If archival tumor tissue is unavailable or is determined to be unsuitable for required testing, tumor tissue must be obtained from a biopsy performed at screening. Refer to Section 6.3 for additional information on tumor specimens collected at screening.\n5. Subjects have not received any prior systemic or locally directed therapy for PC (see exclusion criteria).\n6. Age \\>= 18 years\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n8. Requirements for organ and marrow function:\n\n   * Hemoglobin \\>= 9 g\u002FdL\n   * \\- Participants must not have been transfused within 2 weeks prior to screening to meet this criterion\n   * Absolute neutrophil count \\>= 1,500\u002Fmicroliter (uL) without granulocyte colonystimulating factor support\n   * Absolute lymphocyte count \\>= 500\u002FuL\n   * Platelets \\>= 100,000\u002FuL without transfusion\n   * Total bilirubin \\\u003C 1.5 x institutional upper limit of normal (ULN) (known Gilbert disease: \\\u003C 3 x ULN)\n   * Alkaline phosphatase \\\u003C 2 x institutional ULN\n   * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase (SGOT)) =\\\u003C 2 x institutional ULN\n   * Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase (SGPT)) =\\\u003C 2 x institutional ULN\n   * International normalized ratio (INR) or activated partial thromboplastin time (aPTT) \\\u003C 1.5 x institutional ULN for subjects not receiving therapeutic anticoagulation\n   * Creatinine clearance \\>= 30 mL\u002Fmin (calculated using the Cockcroft-Gault formula)\n   * Serum creatinine \\\u003C=1.6 mg\u002FdL (141 μmol\u002FL) in female patients and ≤1.9 mg\u002FdL (168 μmol\u002FL) in male patients . Patients with serum creatinine values exceeding limits may be eligible for the study if their estimated glomerular filtration rates (GFR) are \\>30\n9. Testosterone level \\> 150 ng\u002FdL.\n10. Contraception: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm as defined below:\n\n    1. With female partners of childbearing potential: men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \\\u003C 1% per year during the treatment period and for 4 months after the last dose of study treatment. Men must refrain from donating sperm during the same period\n    2. With pregnant female partners: men must remain abstinent or use a condom during the treatment period and for 4 months after the last dose of study treatment to avoid exposing the embryo\n    3. Abstinence: the reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception\n11. For patients receiving therapeutic anticoagulation: stable anticoagulant regimen \\> 3 months.\n12. Ability to understand a written informed consent document, and the willingness to sign it.\n13. Ability to comply with the study protocol, in the investigator's judgment.\n\nExclusion Criteria:\n\n1. Evidence of metastatic disease as determined by standard staging scans.\n\n   a. Staging scans should be performed per urologic standard of care for patients undergoing radical prostatectomy \\[per American Urological Association (AUA)\u002FNational Comprehensive Cancer Network (NCCN) guidelines\\].\n2. Not a candidate for radical prostatectomy as determined by treating urologic oncology surgeon.\n3. Any prior systemic therapy for PC, including antiandrogens, androgen deprivation therapy \\[gonadotropin-releasing hormone (GnRH) agonist or antagonist\\], chemotherapy, targeted therapy, immunotherapy, OR radiopharmaceuticals.\n\n   a. Subjects who are on finasteride or dutasteride must discontinue therapy and undergo a washout period of 6 weeks to become eligible for the study. Screening procedures should begin following the washout period.\n4. Prior radiotherapy for PC.\n5. Any history of prior malignancy, except:\n\n   1. Non-melanoma skin cancer treated with curative intent\n   2. Carcinoma-in-situ (CIS) treated with curative intent, without evidence of recurrence or disease progression for 3 years\n   3. Appropriately treated Stage I uterine cancer\n   4. All other cancer: treated with curative intent and without evidence of disease on standard of care follow-up for 5 years\n6. 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, Sjogren's syndrome, Guillain-Barre syndrome, or multiple sclerosis, with the following exceptions:\n\n   1. Subjects with a history of autoimmune-related hypothyroidism who are on thyroid-replacement therapy, with a stable dose \\> 3 months, are eligible for the study\n   2. Subjects with controlled type 1 diabetes mellitus who are on an insulin regimen, with a Glycated hemoglobin (hemoglobin A1C) \\\u003C 7.0 are eligible for the study. All subjects with controlled type 2 diabetes mellitus are eligible for the study\n   3. Subjects with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded from the study) are eligible for the study provided all of the following conditions are met:\n\n      * Rash covers \\\u003C 10% of body surface area\n      * Disease is well controlled at baseline and requires only low-potency topical steroids\n      * 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\n7. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or any evidence of active, non-infectious pneumonitis requiring corticosteroids.\n8. History of prior positive human immunodeficiency virus (HIV) test.\n9. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (chronic or acute).\n\n   1. Subjects with a past or resolved HBV infection are eligible for this study.\n   2. HCV positivity is defined as having a positive HCV antibody test followed by a positive HCV ribonucleic acid (RNA) test at screening; the HCV RNA test will only be performed for subjects who have a positive HCV antibody test.\n10. Significant cardiovascular disease, such as New York Heart Association class III or greater cardiac disease, myocardial infarction, or cerebrovascular accident within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina.\n11. Active chronic obstructive pulmonary disease (COPD) requiring use of home oxygen (O2) or systemic steroid therapy \\> 10 mg prednisone (or equivalent) daily.\n12. Asthma requiring systemic corticosteroids \\> 10 mg prednisone (or equivalent) daily. Inhaled corticosteroids for the treatment of asthma are permitted.\n13. Major surgical procedure (including joint surgery) other than for diagnosis within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the course of the study.\n\n    a. Placement of central venous access catheter (e.g., port or similar) is not considered a major surgical procedure and is therefore permitted.\n14. 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.\n15. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications.\n16. Prior allogeneic stem cell or solid organ transplantation.\n17. Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during the course of the study or within 5 months after the last dose of atezolizumab. Note: Because IL-6 inhibition may interfere with the normal immune response to new antigen, patients should be brought up to date on all recommended vaccinations, except for live vaccines, prior to initiation of therapy with tocilizumab to maximize vaccine response.\n18. Treatment with investigational therapy within 28 days prior to initiation of study treatment.\n19. Prior treatment with adenosine-axis inhibitors, cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies, including anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), ant-PD-1, and anti-PD-L1 therapeutic antibodies.\n20. Treatment with systemic immunostimulatory agents \\[including, but not limited to, interferon and interleukin 2 (IL-2)\\] within 4 weeks or five half-lives of the drug (whichever is longer) prior to initiation of study treatment.\n21. Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor (TNF)- agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during the course of the study, with the following exceptions:\n\n    1. Patients who receive 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. Patients who receive mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma (=\\\u003C 10 mg prednisone or equivalent), or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency (=\\\u003C 10 mg prednisone or equivalent) are eligible for the study.\n22. History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins.\n23. Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation.\n24. Known allergy or hypersensitivity to any of the study drugs of their excipients.\n25. Previous treatment with any cell-depleting therapies, including investigational agents or approved therapies, some examples include: CAMPATH, anti-cluster of differentiation 4 (CD4), anti-cluster of differentiation 5 (CD5), anti-cluster of differentiation 3 (CD3), anti-Cluster of Differentiation 19 (CD19) and anti-Cluster of Differentiation 20 (CD20) within 5 years prior to first dose of study treatment.\n26. Treatment with intravenous gamma globulin, plasmapheresis or Prosorba column within 6 months of baseline.\n27. Previous treatment with tocilizumab (an exception to this criterion may be granted for single dose exposure upon application to the Sponsor-Investigator on a case-by-case basis).\n28. Any previous treatment with alkylating agents such as chlorambucil, or with total lymphoid irradiation within 5 years prior to first dose of study treatment.\n29. History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies.\n30. Evidence of serious uncontrolled concomitant, nervous system, pulmonary, renal, hepatic, endocrine (include uncontrolled diabetes mellitus) or gastrointestinal disease (including complicated diverticulitis, ulcerative colitis, or Crohn's disease).\n31. Any history of recent serious bacterial, viral, fungal, or other opportunistic infections.\n32. Primary or secondary immunodeficiency (history of or currently active) unless related to primary disease under investigation.\n33. Any medical or psychological condition that in the opinion of the principal investigator would interfere with safe completion of the trial.\n34. Pregnant women or nursing (breast feeding) mothers.\n35. Neuropathies or other conditions that might interfere with pain evaluation unless related to primary disease under investigation.\n36. Patients with lack of peripheral venous access\n\n    Additional Exclusion Criteria for Cohort B (atezolizumab + etrumadenant):\n37. Treatment with known P-glycoprotein (P-gp) substrates with a narrow therapeutic window, administered orally (e.g., digoxin) within 4 weeks (for investigational drugs when half-life is unknown or not accurately determined) or 5 drug-elimination half-lives of the drug (when half-life is determined), whichever is longer, or if it is a marketed drug, then 5 drug-elimination half-lives of the drug, prior to initiation of study treatment.\n38. Treatment with known strong CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, phenobarbital, and St. John's Wort) and strong CYP3A4 inhibitors (eg,clarithromycin, grapefruit juice, itraconazole, ketoconazole, posaconazole, telithromycin,and voriconazole) within 4 weeks (for investigational drugs when half-life is unknown or not accurately determined) or 5 drug-elimination half-lives of the drug (when half-life is determined), whichever is longer, or if it is a marketed drug, then 5 drug-elimination half-lives of the drug, prior to initiation of study treatment.\n39. Treatment with known breast cancer resistance protein (BCRP) substrates with a narrow therapeutic window, administered orally (e.g., prazosin, rosuvastatin) within 4 weeks (for investigational drugs when half-life is unknown or not accurately determined) or 5 drug-elimination half-lives of the drug (when half-life is determined), whichever is longer, or if it is a marketed drug, then 5 drug-elimination half-lives of the drug, prior to initiation of study treatment.\n\n    Additional Exclusion Criteria for Cohort C (atezolizumab + tocilizumab):\n40. Known active infection or history of recurrent bacterial, viral, fungal, mycobacterial or other infections, including, but not limited to, TB (i.e., has signs and symptoms of TB) and atypical mycobacterial disease, hepatitis B and C, and herpes zoster, but excluding fungal infections of nail beds.",{"count":86,"type":21},68,[24],"This phase II trial studies how well atezolizumab works alone or in combination with etrumadenant or tocilizumab in treating men with localized prostate cancer before radical prostatectomy. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Androgens can cause the growth of prostate cancer cells. IL-6 is expressed by prostate cancer and within the tumor microenvironment and shown to enhance prostate cancer and disease progression. Treatment with an anti-IL-6 antibody such as tocilizumab may inhibit cancer progression. Giving atezolizumab in combination with etrumadenant or tocilizumab may work better in treating prostate cancer.",[90,65,27],"Prostate Adenocarcinoma",[92],"Neoadjuvant therapy","2026-06-02",{"date":95,"type":37},"2026-06-04",{"date":97,"type":37},"2019-10-30",{"date":99,"type":21},"2027-04-30",{"name":101,"class":102},"David Oh","OTHER",2,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":113,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":45},"100579499","phase-3-is-adaptive-sbrt-for-prostate-vs-image-guided-radiotherapy-a-true-evolution-aspire-100579499","NCT06825091","Is Adaptive SBRT for Prostate vs Image-guided Radiotherapy a True Evolution (ASPIRE)","ASPIRE","Inclusion Criteria:\n\n1. Age \\>18 years\n2. Histologic diagnosis of prostate adenocarcinoma\n3. Localized prostate cancer\n4. Low risk, intermediate risk, or high risk allowed\n5. Patient planned for prostate SBRT\n\nExclusion Criteria:\n\n1. Planned for elective nodal irradiation\n2. Contraindications to radiotherapy\n3. Patients with bilateral hip replacements, as they are ineligible for adaptive treatments at present time (either MR-guided or CT-guided)",{"count":112,"type":21},320,[114],"PHASE3","The ASPIRE study is a Phase III randomized, single-center study designed to evaluate whether adaptive stereotactic body radiotherapy (SBRT) offers superior clinical benefits compared to standard image-guided SBRT for patients with localized prostate cancer. It aims to explore whether adaptive SBRT can improve urinary outcomes while maintaining effective cancer control.\n\nThis interventional study is randomized, single-institution, and includes 320 participants with localized prostate cancer. Patients will be stratified based on fractionation schedules (5 vs. 7 fractions), use of rectal spacers, androgen deprivation therapy (ADT), and baseline alpha receptor antagonist use. Participants will be randomized to receive either adaptive SBRT or standard image-guided SBRT, with both arms adhering to established dosing protocols.\n\nInclusion criteria includes an age greater than 18 years, diagnosed with localized prostate adenocarcinoma, and an ECOG performance status of 0-1, Eligible for prostate SBRT. The exclusion criteria includes patients who plan for elective nodal irradiation and contraindications to radiotherapy or MRI (for MR-Linac patients).",[27,117],"Stereotactic Body Radiotherapy","2026-05-29",{"date":93,"type":37},{"date":121,"type":37},"2025-02-04",{"date":123,"type":21},"2030-02-04",{"name":125,"class":102},"University Health Network, Toronto",{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":22,"phases":136,"briefSummary":137,"conditions":138,"keywords":143,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":158,"leadSponsor":160,"locationsCount":45},"100625701","phase-2-pro-boost-lc-whole-gland-boost-strategies-versus-sbrt-monotherapy-in-psma-staged-localized-and-locally-advanced-prostate-cancer-100625701","NCT07426055","PRO-BOOST-LC: Whole-Gland Boost Strategies Versus SBRT Monotherapy in PSMA-Staged Localized and Locally Advanced Prostate Cancer","PRO-BOOST-LC: A Prospective, Multi-arm Phase II\u002FIII Clinical Trial Evaluating the Efficacy and Safety of Whole-Gland Boost Using HDR Brachytherapy, LDR Brachytherapy, or Single-Fraction SBRT Following an Ultrahypofractionated EBRT (VMAT) Backbone (5 Gy x 5 Fractions) Compared to Standard SBRT Monotherapy in Patients With Localized and Locally Advanced Prostate Cancer Staged With PSMA PET\u002FCT","PRO-BOOST-LC","Inclusion Criteria:\n\n* Male patients aged ≥18 years.\n* Histologically confirmed adenocarcinoma of the prostate.\n* Localized or locally advanced prostate cancer classified as cT1-4, cN0, cM0.\n* Negative pelvic nodal and distant metastatic disease on baseline PSMA PET.\n* NCCN favourbale or unfavourbale intermediate-, high-, or very high-risk disease.\n* Candidate for definitive radiotherapy with curative intent.\n* ECOG performance status 0-2.\n* Baseline PSA available prior to randomization.\n* Ability to undergo external beam radiotherapy and brachytherapy or SBRT according to protocol.\n* Planned androgen deprivation therapy (ADT) permitted according to protocol-defined risk group.\n* Ability to understand and willingness to sign written informed consent.\n\nExclusion Criteria:\n\n* Evidence of pelvic nodal (cN1) or distant metastatic disease (cM1) on baseline imaging.\n* Prior definitive local treatment for prostate cancer, including prostatectomy, brachytherapy, or definitive external beam radiotherapy.\n* Prior pelvic radiotherapy for any malignancy.\n* Prior systemic therapy for prostate cancer other than protocol-allowed neoadjuvant ADT.\n* History of other active malignancy requiring systemic treatment (except adequately treated non-melanoma skin cancer).\n* Contraindications to radiotherapy or anesthesia required for brachytherapy procedures.\n* Severe uncontrolled comorbidities that would preclude protocol treatment.\n* Inability to comply with study procedures or follow-up schedule.",{"count":135,"type":21},1200,[24,114],"PRO-BOOST-LC is a prospective, multicenter, randomized clinical trial designed for patients with localized prostate cancer who do not have evidence of lymph node or distant metastases based on modern PSMA PET imaging.\n\nProstate cancer is one of the most common cancers in men. For patients with disease confined to the prostate, radiotherapy is a well-established and effective curative treatment option. Over the past decades, research has shown that delivering higher radiation doses to the prostate can improve cancer control and reduce the risk of disease recurrence. However, higher radiation doses may also increase the risk of side effects affecting urinary, bowel, and sexual function. For this reason, different radiation techniques have been developed to safely deliver higher doses while protecting surrounding healthy organs.\n\nSeveral approaches to radiation dose escalation are currently used in clinical practice. These include stereotactic body radiotherapy (SBRT), which delivers radiation in a small number of highly precise treatments, as well as brachytherapy, where radioactive sources are placed directly inside the prostate for a short time (high-dose-rate brachytherapy) or permanently (low-dose-rate brachytherapy). Although all these approaches are accepted and widely used, it is not known which strategy provides the best balance between cancer control, treatment-related side effects, and long-term quality of life, particularly when modern imaging techniques are used to accurately stage the disease.\n\nThe PRO-BOOST-LC study aims to directly compare different radiation dose escalation strategies using a standardized treatment framework. All participants enrolled in the study will have localized prostate cancer staged with PSMA PET imaging to exclude metastatic disease. Participants will then be randomly assigned to one of four treatment groups. One group will receive SBRT alone to the prostate. The other three groups will receive a short course of external beam radiotherapy followed by an additional focused radiation boost delivered using one of three methods: high-dose-rate brachytherapy, low-dose-rate brachytherapy, or SBRT. All treatment approaches used in this study are established methods routinely applied in clinical practice.\n\nRandomization ensures that each participant has an equal chance of being assigned to any of the treatment groups. This allows the study to fairly compare outcomes between the different strategies. The main objective of the trial is to determine whether adding a radiation boost improves treatment outcomes compared with SBRT alone. The primary outcome measure is failure-free survival, which includes cancer recurrence, disease progression, the need for additional cancer treatment, or death from any cause. Secondary outcomes include the development of distant metastases, overall survival, treatment-related side effects, and patient-reported quality of life.\n\nParticipants will be closely monitored throughout the study. Before treatment, patients will undergo clinical evaluation, blood tests including prostate-specific antigen (PSA), imaging studies, and quality-of-life assessments. During and after treatment, participants will attend regular follow-up visits. These visits will include clinical examinations, PSA testing, assessment of treatment-related side effects, and completion of standardized questionnaires evaluating urinary, bowel, and sexual function, as well as overall quality of life. Imaging studies, including PSMA PET scans, will be performed when clinically indicated to assess for possible disease recurrence or progression.\n\nThe study is designed to follow participants for many years in order to capture both early and long-term outcomes. By using modern radiotherapy techniques, standardized treatment protocols, and comprehensive follow-up, PRO-BOOST-LC aims to generate high-quality evidence that will help guide future treatment decisions for patients with localized prostate cancer. The results of this trial are expected to improve understanding of how best to use radiation dose escalation to maximize cancer control while minimizing side effects and preserving quality of life in the era of advanced imaging and precision radiotherapy.\n\nParticipation in this study does not involve experimental or unproven treatments. All radiation techniques used in PRO-BOOST-LC are approved, widely available, and considered standard of care in many treatment centers worldwide. The study focuses on optimizing how these existing techniques are combined and delivered, rather than introducing new drugs or devices. Participation may involve additional follow-up assessments and questionnaires compared with routine care, but treatment decisions are made within established clinical practice guidelines. Patients may or may not directly benefit from participation, but the information gained from this study may help improve future treatment strategies for men with localized prostate cancer.",[139,140,141,142,27],"Prostate Cancer (Adenocarcinoma)","Prostate Brachytherapy","Stereotactic Body Radiation Therapy (SBRT)","Dose Escalation: Solid Tumors",[29,117,144,145,146,147,148,149,150,151,152,153],"SBRT","Brachytherapy","High-Dose-Rate Brachytherapy","Low-Dose-Rate Brachytherapy","Dose Escalation","Ultrahypofractionation","PSMA PET","Prostate-Specific Membrane Antigen","Metastasis-Free Survival","Failure-Free Survival","2026-03-19",{"date":156,"type":37},"2026-03-23",{"date":154,"type":37},{"date":159,"type":21},"2035-12",{"name":161,"class":102},"Affidea Nu-med Center of Oncological DIagnostics and Therapy",{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":22,"phases":171,"briefSummary":172,"conditions":173,"keywords":175,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":45},"100590389","oxybutynin-er-to-promote-early-continence-recovery-after-robotic-prostatectomy-a-randomized-controlled-trial-100590389","NCT06966778","Oxybutynin ER to Promote Early Continence Recovery After Robotic Prostatectomy: A Randomized Controlled Trial","A Double Blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy of Oxybutynin Chloride Extended-Release Tablets to Improve Early Continence Recovery After Robotic Prostatectomy","Inclusion Criteria:\n\n* Diagnosis: Patients with localized prostate cancer who are scheduled to undergo robot-assisted radical prostatectomy (RARP).\n* Age: Participants must be 18 years or older, with no upper age limit.\n* Consent: Participants must provide written informed consent before undergoing any study procedures.\n* Ability to Follow Protocol: Participants must be able to follow the protocol procedures throughout the study.\n\nExclusion Criteria:\n\n* Surgical Complications: Participants who experience surgical complications during or after RARP requiring extraordinary medical or surgical treatment.\n* Other Urinary Conditions: Participants with other diseases causing lower urinary tract symptoms (LUTS) or bladder pain, including:\n* \\- Benign prostatic hyperplasia (BPH), chronic prostatitis, interstitial cystitis, painful bladder syndrome, or urinary tract infection.\n* \\- Overactive bladder or any other condition affecting bladder function.\n* Chronic Medication: Participants with long-term use of medications such as:\n* \\- Alpha-blockers, antimuscarinics, or anticholinergics.\n* Glaucoma: Participants with narrow-angle glaucoma.\n* Urinary Retention: Participants with a history of urinary retention.\n* Gastrointestinal Motility Issues: Participants with severe conditions affecting gastrointestinal motility.\n* Concurrent Medications: Participants who are taking medications that are prohibited by the study protocol (e.g., cholinergic drugs, azole antifungals, smooth muscle relaxants).",{"count":170,"type":21},135,[57],"The goal of this double-blind, randomized, placebo-controlled study is to evaluate whether oxybutynin chloride extended-release tablets can improve early continence recovery after robot-assisted radical prostatectomy (RARP) in patients with localized prostate cancer.\n\nThe main questions it aims to answer are:\n\n\\[Does oxybutynin chloride improve continence recovery after RARP compared to a placebo?\\] \\[What are the predictors of continence recovery?\\]\n\nResearchers will compare the treatment group (oxybutynin chloride 10 mg\u002Fday) with the control group (placebo) to assess differences in continence outcomes.\n\nParticipants will:\n\n\\[Take the assigned medication (oxybutynin chloride or placebo) daily for 1-3 months until continence recovery.\\] \\[Complete surveys (e.g., IPSS, IIEF, ICIQ) at several time points post-surgery, including before surgery, 10 days after Foley catheter removal, and up to 12 months.\\] \\[Record any adverse events or concomitant medication use.\\]\n\nSafety and tolerability will be monitored, and statistical analyses will determine the efficacy and predictors of continence. The study adheres to ethical principles, local regulations, and GCP guidelines.",[27,174],"Postoperative Urinary Incontinence",[27,176,177,174,178,179,180,181],"Robot-Assisted Radical Prostatectomy (RARP)","Early Continence Recovery","Oxybutynin Chloride","Extended-Release Tablets","Double-Blind Randomized Study","Placebo-Controlled Trial","2026-03-12",{"date":184,"type":37},"2026-03-16",{"date":186,"type":37},"2025-09-15",{"date":188,"type":21},"2028-12-31",{"name":190,"class":102},"National Taiwan University Hospital",{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":197,"eligibilityCriteria":198,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":199,"targetDuration":4,"studyType":22,"phases":201,"briefSummary":202,"conditions":203,"keywords":206,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":45},"100525078","the-precision-study-3-fractions-of-prostate-sbrt-and-raypilot-hypocath-image-guidance-100525078","NCT06117059","The PRECISION Study: 3 Fractions of Prostate SBRT and RayPilot HypoCath Image Guidance","The PRECISION Study: A Phase II Study of 3 Fractions of Prostate SBRT With RayPilot System and HypoCath Image Guidance for Men With NCCN Low or Intermediate Risk Prostate Cancer","PRECISION","Inclusion Criteria:\n\n* low and favorable intermediate NCCN Criteria patients\n* Prostate volume under 80cc\n* IPSS under 20\n* Q-max above 10cc per second and urinary residual less than 150mls\n* No TURP\n* No hip replacements\n* No previous radiotherapy to the pelvis\n* No active second malignancy except skin SCC or BCC for the last 2 years\n* No history of inflammatory bowel disease\n* No co-morbid illness that would make compliance to treatment difficult\n* Able to give informed consent\n\nExclusion Criteria:\n\n* T3a or above\n* Gleason 4+3=7\n* PSA\\>20ng\u002Fml",{"count":200,"type":21},100,[57],"The investigators want to investigate whether it is possible to reduce the number of curative radiotherapy doses from 5 to only 3 for men with localized early prostate cancer. The aim of the study is to ensure that the side effects of the 3-dose treatment are the same or potentially lower than those already published when using the 5-dose treatment as used in the UK PACE-B trial (NCT01584258). The name of this type of radiotherapy is Stereotactic Body Radiotherapy (SBRT) or participants may see it referred to as Stereotactic Ablative Radiotherapy (SABR). The study is a two-stage single arm Phase II study open to those Centres that use the RayPilot HypoCath tumour tracking system (Micropos Medical). This commercially available system was not available at the time of the original PACE-B study. The system acts like a Global Positioning Device (GPS) to continuously track the prostate position during radiotherapy. If the prostate moves more than 2mm (about 0.08 in) from its intended position during the treatment, then the radiotherapy team are alerted, and the treatment halted until the prostate moves back into the correct position. The ability to understand exactly where the prostate is throughout the treatment ensures the intended dose hits the cancer and does not accidentally increase the dose to the nearby bladder and rectum. The system is a modification of a standard urinary catheter which sits within the bladder with the GPS placed within the wall of the catheter as it passes through the prostate. The investigators are not testing the system as it is commercially available but using it to improve the accuracy of radiotherapy delivery, reducing the number of days of treatment, minimizing side effects and helping ease the burden on busy radiotherapy Departments.",[27,204,205],"Low Risk Prostate Cancer","Intermediate Risk Prostate Cancer",[144,207,208,209,210,211,212],"SABR","PROSTATE CANCER","RayPilot","HypoCath","Continuous tracking","3 fractions","2026-01-08",{"date":215,"type":37},"2026-01-12",{"date":217,"type":37},"2024-11-01",{"date":219,"type":21},"2027-11-01",{"name":221,"class":222},"NHS Lothian","OTHER_GOV",{"id":224,"slug":225,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":230,"targetDuration":4,"studyType":22,"phases":232,"briefSummary":233,"conditions":234,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":45},"100541124","radical-hypofractionated-radiotherapy-for-localized-prostate-cancer-100541124","NCT06325774","Radical Hypofractionated Radiotherapy for Localized Prostate Cancer","Safety and Efficacy Study of Hypofractionated Radiotherapy for Localized Prostate Cancer: a Single-arm Clinical Trial","Inclusion Criteria:\n\n* Age: ≥18 years old;\n* European Cooperative Oncology Group score(ECOG):≤ 2;\n* Patients with pathologically diagnosed prostate cancer;\n* Clinical stage was cTanyN0M0 any Gleason \u002F ISUP group;\n* Expected survival time \\>5 years;\n* The patient has no contraindications to radiotherapy and is suitable and willing to undergo radiotherapy;\n* Patients who voluntarily accept the experimental study protocol after being informed about the existing treatment options;\n\nExclusion Criteria:\n\n* Patients who have received any other early treatment for prostate cancer, including radiotherapy, chemotherapy, focal therapy, etc;\n* a previous history of pelvic and abdominal radiotherapy;\n* Prior hormonal therapy (castration or antiandrogen);\n* Patients with other malignancies and acute or chronic infections such as human immunodeficiency virus (HIV) (+), hepatitis C virus (HCV) (+) and\u002For positive syphilis;\n* Patients that the investigator considers unsuitable to participate in the clinical trial; patients with other serious systemic diseases, evaluation and compliance of the trial, including severe respiratory, circulatory, neurological, mental, digestive, endocrine, immune, urinary, and other systemic diseases;\n* Patients with contraindications related to radiotherapy;\n* Participate in other clinical trials that are mutually exclusive with the study intervention within 4 weeks prior to the start of the study;\n* Patients unable to provide written informed consent or demonstrate poor treatment compliance",{"count":231,"type":21},20,[57],"The aim of this trial is to study the safety outcomes of hypofractionated radiotherapy in treating patients with localized prostate cancer.\n\nHypofractionated radiotherapy delivers higher doses of radiotherapy in a shorter time period, may enabling the killing of more tumor cells with fewer side effects.\n\nAccumulating evidence has proven the safety and feasibility of hypofractionated radiotherapy for localized prostate cancer.But for localized prostate cancer,the optimal dose per fraction of hypofractionated radiotherapy is still on its way.",[27],"2024-08-22",{"date":237,"type":37},"2024-08-26",{"date":239,"type":21},"2024-09-01",{"date":241,"type":21},"2031-09-01",{"name":243,"class":102},"Changhai Hospital",{"id":245,"slug":246,"hasResults":11,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":4,"eligibilityCriteria":250,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":251,"targetDuration":4,"studyType":22,"phases":253,"briefSummary":254,"conditions":255,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":256,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":45},"100541141","hypofractionated-post-prostatectomy-radiotherapy-hyportfor-localized-prostate-cancer-100541141","NCT06325995","Hypofractionated Post-prostatectomy Radiotherapy (HYPORT)for Localized Prostate Cancer","Safety and Efficacy Study of Hypofractionated Post-prostatectomy Radiotherapy (HYPORT)for Localized Prostate Cancer: a Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* European Cooperative Oncology Group score(ECOG):≤ 2;\n* Patients with pathologically confirmed prostate cancer and completed radical resection of prostate cancer;\n* Postoperative pathological staging of AJCC version 8 pT 3a, pT 3b, pT 4, margin (+), or N1; or serum PSA≥0.1 ng\u002Fml 6 weeks after surgery; or serum PSA \\\u003C0.1 ng\u002Fml 6 weeks after surgery, subsequent follow-up process revealed two consecutive sustained PSA increases (≥0.1 ng \u002F ml) and no clinical imaging (Whole Body Scan (ECT), magnetic resonance imaging (MRI),68Ga PSMA PET \u002F CT, etc.) signs of metastasis;\n* Expected survival time \\>5 years;\n* Patients who voluntarily accept the experimental study protocol after informing the existing treatment options;\n\nExclusion Criteria:\n\n* poor recovery of postoperative urinary control;\n* a previous history of pelvic and abdominal radiotherapy;\n* Participate in other clinical trials that are mutually exclusive with the study intervention within 4 weeks prior to the start of the study;\n* Patients with other malignancies and acute or chronic infections such as human immunodeficiency virus (HIV) (+), hepatitis C virus (HCV) (+) and\u002For positive syphilis;\n* Patients that the investigator considers unsuitable to participate in the clinical trial; patients with other serious systemic diseases, evaluation and compliance of the trial, including severe respiratory, circulatory, neurological, mental, digestive, endocrine, immune, urinary, and other systemic diseases;\n* Patients with contraindications related to radiotherapy;\n* Written informed consent could not be provided, and treatment compliance was poor.Patients unsuitable for participation in this clinical trial as per the judgement of the investigator.",{"count":252,"type":21},428,[57],"The aim of this trial is to compare the safety outcomes of Hypofractionated postprostatectomy radiotherapy (HYPORT) and Conventionally fractionated postprostatectomy radiotherapy(COPORT) in treating patients with localized prostate cancer.\n\nAccumulating evidence has proven the safety and feasibility of HYPORT for localized prostate cancer.But for localized prostate cancer,the optimal dose per fraction of HYPORT is still on its way.\n\nIt is not yet known whether giving HYPORT(57.5-65 Gy in 23-26 daily fractions of 2.5 Gy ) with or COPORT may work better in treating patients with prostate cancer.",[27],{"date":237,"type":37},{"date":258,"type":37},"2024-02-01",{"date":260,"type":21},"2031-02-01",{"name":243,"class":102},{"id":263,"slug":264,"hasResults":11,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":268,"eligibilityCriteria":269,"healthyVolunteers":11,"sex":16,"minAge":270,"maxAge":4,"enrollmentInfo":271,"targetDuration":4,"studyType":273,"phases":4,"briefSummary":274,"conditions":275,"keywords":276,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":45},"100543953","clinical-study-of-hifu-for-localized-prostate-cancer-100543953","NCT06362577","Clinical Study of HIFU for Localized Prostate Cancer","Post-marketing Clinical Study of Transrectal High-intensity Focused Ultrasound for Localized Prostate Cancer","HIFU","Inclusion Criteria:\n\n1. Men over the age of Forty;\n2. Localized prostate cancer for which transperineal template prostate biopsy or MRI targeted biopsy combined with systematic biopsy is performed;\n3. Ti-T2cN0M0 disease stage; Serum psa \\&amp;lt; 20 ng\u002Fml; Gleason score ≤7(3+4 or 4+3 or lower); Or the researcher evaluates the medium-low risk prostate cancer within T2 stage without lymph node and distant metastasis; Treatment was performed using Sonablate® transrectal high intensity focused ultrasound (HIFU) or robot-assisted laparoscopic radical prostatectomy (RALP)\n\nExclusion Criteria:\n\n* Either must be \\&amp;#34;No\\&amp;#34; or the patient cannot be enrolled.\n\n  1. The active stage accompanied by other genitourinary system infections 100 days before surgery;\n  2. Men who have previously received radiation therapy;\n  3. Laboratory-assessed abnormalities of renal function in the heart and liver prior to surgical treatment: ALT, AST, or serum alkaline phosphatase levels above the upper limit of 3-fold normal, coagulation disorders, other malignancies (history of other malignancies other than basal cell carcinoma or squamous skin carcinoma. Patients with a pre-operative history of malignancy that has not recurred in the last 5 years (superficial bladder cancer normally clears in 2 years) are permitted;\n  4. The presence of a metal implant\u002Fstent in the urethra;\n  5. Patients whose lesions were located at the anterior tip of the prostate and in front of the urethra, and other locations where the focus could not be reached or the acoustic channels were blocked by important organs;\n  6. Those who were considered by the investigator to be unsuitable to participate in this clinical trial (such as patients with mental or emotional problems, patients with hearing, speaking, reading, and writing disorders, and poor compliance).","40 Years",{"count":272,"type":21},60,"OBSERVATIONAL","In this study, the safety and effectiveness data of Sonablate system, a transrectal high-intensity focused ultrasound therapeutic instrument, in the treatment of localized prostate cancer were collected, and the treatment conditions of patients with other methods (such as radical prostatectomy) were compared and analyzed. Observe the differences in treatment effect, survival rate, postoperative PSA, recurrence and complications.\n\nTo analyze and compare the clinical outcome, postoperative complications and tumor control of HIFU and robot-assisted laparoscopic radical prostatectomy for localized prostate cancer, and to explore the effectiveness and safety of HIFU in the treatment of localized prostate cancer, so as to provide an alternative treatment for localized prostate cancer.",[27],[268,277],"Localized prostate cancer","2024-08-13",{"date":280,"type":37},"2024-08-15",{"date":282,"type":37},"2024-05-21",{"date":284,"type":21},"2026-12-31",{"name":286,"class":102},"RenJi Hospital",{"id":288,"slug":289,"hasResults":11,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":4,"eligibilityCriteria":293,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":294,"enrollmentInfo":295,"targetDuration":4,"studyType":22,"phases":297,"briefSummary":298,"conditions":299,"keywords":300,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":45},"100440057","phase-2-functional-image-guided-carbon-ion-irradiation-with-simultaneous-integrated-boost-for-prostate-cancer-100440057","NCT05010343","Functional Image-Guided Carbon Ion Irradiation With Simultaneous Integrated Boost for Prostate Cancer","Functional Image-Guided Carbon Ion Irradiation With Simultaneous Integrated Boost for Prostate Cancer: a Phase II Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* Pathologically confirmed adenocarcinoma of prostate\n* Stage cT1-3N0M0 localized prostate cancer\n* performed PSMA PET\u002FCT and mpMRI before treatment\n* No lymph nodes or distant metastasis\n* Age ≥ 45 and \\\u003C 85 years of age\n* Karnofsky Performance Score ≥70\n* No previous pelvic radiation therapy (RT)\n* No previous prostatectomy\n* No previous invasive cancer (within 5 years before the prostate cancer diagnosis)\n* Ability to understand character and individual consequences of the clinical trial\n* Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial\n\nExclusion Criteria:\n\n* No pathologically confirmed adenocarcinoma of the prostate\n* Pelvic lymph node metastasis (N1)\n* Distant metastasis (M1)\n* Previous pelvic radiotherapy\n* Previous prostatectomy","85 Years",{"count":296,"type":21},140,[24],"This is a phase II randomized controlled clinical trial to assess the toxicities and clinical efficacy of prostate specific membrane antigen (PSMA) positron emission tomography \u002F computed tomography (PET\u002FCT) and multi- parameter Magnetic Resonance Imaging (MRI) guided simultaneous integrated boost for prostate cancer.",[27],[301,302,303,304],"carbon ion irradiation","Simultaneous Integrated Boost","PSMA PET\u002FCT","mpMRI","2021-11-12",{"date":307,"type":37},"2021-11-15",{"date":309,"type":37},"2020-10-15",{"date":311,"type":21},"2028-07-01",{"name":313,"class":102},"Shanghai Proton and Heavy Ion Center"]