[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"localized-prostate-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:localized-prostate-carcinoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,20,0,[8,44,79,103,128,151,179,204,226,246,267,289,316,352,378,399,420,450,478,506],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100529790","focal-ablation-with-focal-cryotherapy-or-hifu-for-the-treatment-of-men-with-localized-prostate-cancer-100529790",false,"NCT06178354","Focal Ablation With Focal Cryotherapy or HIFU for the Treatment of Men With Localized Prostate Cancer","A Pragmatic Phase 2 Study of Focal Ablation (Focal Cryotherapy or High Intensity Frequency Ultrasound) in Men With Clinically Localized Prostate Cancer","Inclusion Criteria:\n\n* Ability to understand and willingness to sign an informed consent form\n* Clinically localized grade group 1, 2, or 3 prostate cancer and unilateral magnetic resonance imaging (MRI) visible lesion(s). Up to 3 lesions will be allowed for focal treatment\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (Karnofsky ≥ 70%)\n* Patients ≥ 18 years of age at time of consent\n* Life expectancy ≥ 5 years\n* Ability and stated willingness to adhere to the study visit schedule and other protocol procedures\u002Frequirements for the duration of the study\n\nExclusion Criteria:\n\n* Nodal or distant metastases\n* Prior treatment for prostate cancer\n* Anticipated treatment with any cancer intervention, including radiation, hormonal therapy or surgery ≤ 6 months prior to focal therapy in this study\n* Known contraindications to general anesthesia\n* Uncorrectable coagulopathy\n* Significant active cardiac disease within the previous 6 months including: New York Heart Association (NYHA) class 4 congestive heart failure (CHF), unstable angina, or myocardial infarction\n* Any condition that would prohibit the understanding or rendering of informed consent\n* Any condition that in the opinion of the investigator would interfere with the participant's safety or compliance while on trial","MALE","18 Years",{"count":19,"type":20},100,"ESTIMATED","INTERVENTIONAL",[23],"NA","This clinical trial evaluates the effectiveness of focal ablation with either focal cryotherapy or high intensity frequency ultrasound for the treatment of men with localized prostate cancer. Focal cryotherapy kills tumor cells by freezing them. High intensity frequency ultrasound uses highly focused ultrasound waves to produce heat and destroy tumor cells.",[26,27,28,29,30],"Localized Prostate Carcinoma","Stage I Prostate Cancer AJCC v8","Stage II Prostate Cancer AJCC v8","Stage IIIA Prostate Cancer AJCC v8","Stage IIIB Prostate Cancer AJCC v8","RECRUITING","2026-06-25",{"date":34,"type":35},"2026-06-30","ACTUAL",{"date":37,"type":35},"2023-11-09",{"date":39,"type":20},"2029-06",{"name":41,"class":42},"University of California, Davis","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":43},"100641941","phase-2-study-of-psma-targeted-therapy-and-androgen-receptor-suppression-in-low-volume-metastatic-prostate-cancer-sparkle-trial-100641941","NCT07650240","Study of PSMA-targeted Therapy and Androgen Receptor Suppression in Low-volume Metastatic ProstatE Cancer: SPARKLE Trial","A Phase II Randomized Trial of Intermittent Androgen Deprivation Therapy Alone or Combined With [177Lu]Lu-PSMA-617, With or Without Abiraterone and Prednisone, in Patients With Low-Volume Metastatic Hormone-Sensitive Prostate Cancer","SPARKLE","Inclusion Criteria:\n\n* Male patients aged 18 years or older\n* Signed informed consent must be obtained prior to participation in the study\n* Histologically confirmed adenocarcinoma of the prostate\n* Prior treatment with radical prostatectomy or radiation therapy for localized disease is required\n* Prior treatment with ADT or androgen receptor pathway inhibitor (ARPI) or cytotoxic chemotherapy is permitted if:\n\n  * The last treatment \\> 12 months from enrollment on the trial\n  * The duration of treatment is less than 3 months and no evidence of disease progression on treatment\n* Disease detected on PSMA PET\u002FCT scan \\[PSMA-avid low volume metastasis (LVM)\\]. Patients with standardized uptake value maximum (SUVMax) lesion\u002Fliver \\>1 \\[molecular imaging PSMA (miPSMA) score of 2\\] or lesion\u002Fparotid \\> 1 (miPSMA score of 3) would be included. PET scanners used in the study will comply with current guidelines established by the European Association of Nuclear Medicine (EANM) Research Limited (Ltd) (EARL) for harmonizing PET\u002FCT image acquisition and reconstruction\n* Patients with hormone sensitive low volume metastatic disease (LVM); either de novo metastatic or recurrent disease. LVM, as assessed on PSMA PET\u002FCT is defined as:\n\n  * =\\\u003C 10 total metastatic spots\n\n    * Lymph nodes with short axis of =\\\u003C 2.5 cm\n    * Total tumor volume (TTV) \\\u003C 200 mL\n  * =\\\u003C 4 bone metastases\n  * No brain or liver metastases\n* Eastern Cooperative Oncology Group (ECOG) performance 0 - 2\n* Hemoglobin \\>= 9 g\u002FdL\n* Platelet count \\>= 100,000\u002Fmm\\^3\n* Absolute neutrophil count \\>= 1,500\u002Fmm\\^3\n* Serum bilirubin =\\\u003C 1.5 x upper limit of normal (ULN)\n* Alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) =\\\u003C 2.5 x ULN\n* Serum creatinine =\\\u003C 1.5 x ULN or an estimated glomerular filtration rate (eGFR) \\>= 50 mL\u002Fmin\u002F1.73m\\^2\n* Able to start therapy within 28 days of screening\n* Expected life expectancy \\> 6 months\n\nExclusion Criteria:\n\n* PSMA-undetectable disease defined as rising prostate specific antigen (PSA) with absence of PSMA-positive lesions in PSMA PET\u002FCT imaging\n* PSMA-negative disease defined as lesions detected on imaging that are deemed concerning for active cancer metastasis with PSMA SUVmax less than liver and meeting specific size criteria: lymph nodes with short axis of \\>= 2.5 cm, visceral lesions with a solid appearance (soft tissue density) \\>= 1 cm, and bone metastases with a measurable soft tissue component \\>= 1 cm\n* Patient with in-field failure (disease recurrence in prostate bed after primary definitive prostatectomy or radiotherapy)\n* Patient with spinal metastatic disease-causing cord compression\n* Patient with prior disease progression on ADT \\[castration resistance prostate cancer (CRPC)\\]\n* Prior treatment with ADT or cytotoxic chemotherapy or ARPI within less than 12 months from enrollment on the trial\n* Prior treatment with ADT or ARPI or cytotoxic chemotherapy is permitted only if more than 3 months treatment duration and no evidence of disease progression on treatment\n* Patients with severe \\[Common Terminology Criteria for Adverse Events (CTCAE) grade \\> 2\\] xerostomia\n* Patients with well documented history of myelosuppression or renal disease that might impair their participation in the trial per medical advice\n* Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, participants with a prior history of malignancy that has been adequately treated non-melanoma skin cancer, superficial bladder cancer are eligible\n* Estimated life expectancy \\\u003C 6 months\n* Concurrent serious medical co-morbidities as determined by study investigator and expected to impair participation in the study\n\n  * Subjects with female partners of reproductive potential are required to use effective, medically acceptable methods of birth control (e.g., spermicide in conjunction with a barrier such as a condom or sexual abstinence) while on this study, and for 14 weeks after the last dose of 177Lu-PSMA-617",{"count":53,"type":20},202,[55],"PHASE2","This phase II trial tests leuprolide acetate alone versus in combination with 177Lu-PSMA-617, with or without abiraterone acetate and prednisone, for the treatment of hormone-sensitive prostate cancer has spread to a limited number of anatomic sites at the time of initial diagnosis (de novo low volume metastasis) or that has come back after a period of improvement (recurrent). Standard of care treatment for prostate cancer usually includes androgen deprivation therapy, with or without abiraterone acetate and prednisone. Leuprolide acetate is a form of androgen deprivation therapy. It blocks the body from making testosterone (a male hormone) and estradiol (a female hormone). It may stop the growth of prostate cancer cells that need testosterone to grow. 177Lu-PSMA-617 is a type of radioconjugate drug. Upon administration, vipivotide tetraxetan targets and binds to prostate specific membrane antigen (PSMA)-expressing tumor cells. Upon binding, PSMA-expressing tumor cells are destroyed by 177Lu through the specific delivery of radiation. PSMA, a tumor-associated antigen and type II transmembrane protein, is overexpressed on prostate tumor cells. Abiraterone acetate is a type of anti-androgen drug. It blocks tissues from making androgens (male hormones), such as testosterone. This may cause the death of cancer cells that need androgens to grow. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Giving 177Lu-PSMA-617 in combination with leuprolide acetate, with or without abiraterone acetate and prednisone, may be more effective at treating patients with recurrent or de novo low volume metastatic hormone-sensitive prostate cancer than giving leuprolide acetate alone.",[58,59,60,61,62,63,64,26,65,66,67,68],"Recurrent Prostate Adenocarcinoma","Stage IVB Prostate Cancer AJCC v8","Castration-Sensitive Prostate Cancer","Metastatic Hormone-sensitive Prostate Cancer (mHSPC)","Prostate Cancer","Prostate Adenocarcinoma","Adenocarcinoma of the Prostate","Metastatic Prostate Cancer","Metastatic Prostate Adenocarcinoma","Advanced Prostate Cancer","Advanced Prostate Adenocarcinoma","NOT_YET_RECRUITING","2026-06-15",{"date":72,"type":35},"2026-06-17",{"date":74,"type":20},"2026-07-01",{"date":76,"type":20},"2030-12-30",{"name":78,"class":42},"Mayo Clinic",{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":21,"phases":89,"briefSummary":90,"conditions":91,"keywords":92,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":43},"100642245","phase-2-mri-based-focal-intraprostatic-simultaneous-integrated-boost-sib-intensification-with-de-escalated-adaptive-risk-sbrt-for-patients-with-low-to-intermediate-risk-prostate-cancer-100642245","NCT07644598","MRI-based Focal Intraprostatic Simultaneous Integrated Boost (SIB) Intensification With De-escalated Adaptive-risk SBRT for Patients With Low to Intermediate Risk Prostate Cancer","A Phase II Study of MRI-based Focal Intraprostatic SIB (Simultaneous Integrated Boost) Intensification With De-escalated Adaptive-risk SBRT for Patients With Low to Intermediate Risk Prostate Cancer","MIDAS","Inclusion Criteria:\n\n1. Patients age 18 or older.\n2. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n3. Patients with histologically confirmed adenocarcinoma of the prostate who have not received prior pelvic radiation therapy or prostatectomy.\n4. Patients with low to intermediate risk group defined by the NCCN (National Comprehensive Cancer Network) guidelines as follows:\n\n   * Low risk prostate cancer:\n\n     * cT1-cT2a (AJCC; 8TH edition, 2017)\n     * Grade Group 1 (GG1)\n     * PSA \\\u003C10 ng\u002FmL\n   * Intermediate risk prostate cancer:\n\n     * cT2b-cT2c (AJCC; 8TH edition, 2017)\n     * Grade Group 2 (GG2) or Grade Group 3 (GG3)\n     * PSA 10-20 ng\u002FmL\n5. Patients with unfavorable intermediate risk prostate cancer defined by the NCCN guidelines are recommended to undergo a PSMA (Prostate-Specific Membrane Antigen) PET, then the PSMA PET must show localized disease.\n6. Patients must have preferably undergone a standard of care pretreatment MRI fusion biopsy\\* to identify visible intraprostatic lesions and confirm the absence of regional or distant metastatic disease, with criteria as follows:\n\n   * Ability to undergo an MRI fusion biopsy;\n   * Prostate size \\\u003C100 cc on any diagnostic MRI;\n   * Presence of a visible prostatic lesion:\n\n     * PIRADS (Prostate Imaging-Reporting and Data System) 4+ lesion, and\u002For\n     * PIRADS 3 lesion with evidence of grade group 2-3\n   * Less than or equal to 4 lesions in total allowed;\n   * Lesion may contact the capsular edge, \"possible\" extracapsular extension (ECE) permitted; \\*MRI fusion biopsy is preferred but if the positive core is in the same region as the target on the MRI based on a systemic biopsy, the patient can be included.\n7. Genitourinary function with a baseline score ≤20 as defined by any pre-treatment IPSS questionnaire.\n8. Patients are mandated to get a fiducial placement. Optional proper rectal spacer placement is recommended as determined by the treating radiation oncologist based upon whether there is overt rectal wall invasion from the hydrogel spacer or if there is minimal to no separation of the prostate-rectal interface measured at the prostate mid-gland.\n9. Patients with a life expectancy of greater than 5 years as assessment by the investigator. Life expectancy can be estimated using any 1 of the following tools:\n\n   * The Social Security Administration tables: https:\u002F\u002Fwww.ssa.gov\u002FOACT\u002FSTATS\u002Ftable4c6.html\n   * The WHO's Life Tables by country: https:\u002F\u002Fapps.who.int\u002Fgho\u002Fdata\u002Fview.main.60000?lang=en\n   * The Memorial Sloan Kettering Male Life Expectancy tool: https:\u002F\u002Fwww.mskcc.org\u002Fnomograms\u002Fprostate\n   * If using a life expectancy table, life expectancy should be adjusted using the clinician's assessment of overall health as follows: best quartile of health - add 50%; worst quartile of health - subtract 50%; and middle two quartiles of health - no adjustment. See the NCCN Prostate Cancer Guidelines for more information.\n10. Patients who agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agree to refrain from donating sperm, as defined below:\n\n    * With a female partner of childbearing potential who is not pregnant, men who are not surgically sterile must remain abstinent or use a condom plus an additional contraceptive method, which together result in a failure rate of \\\u003C 1% per year, during the treatment period and for 1 year after treatment per local and institutional guidelines. Men must refrain from donating sperm during this same period.\n    * With a pregnant female partner, men must remain abstinent or use a condom during the treatment period per local and institutional guidelines to avoid potential exposure to the embryo.\n    * 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 post-ovulation methods) and withdrawal are not adequate methods of contraception.\n11. Patients who are able to give informed consent.\n\nExclusion Criteria:\n\n1. Patients with evidence of disease Grade Group 4 (GG4) or higher.\n2. Patients with PSA \\>20 ng\u002FmL.\n3. Patients with evidence of clinical stage T3a+ or gross extracapsular extension on the diagnostic MRI.\n4. Patients who received prior or concurrent androgen deprivation therapy for prostate cancer.\n5. Patients with more than 4 disease foci identifiable on MRI.\n6. Patients with evidence of metastatic disease on imaging (e.g., bone scan, PSMA PET scan, or MRI\u002FCT scan).\n7. Patients with ineligibility to undergo an MRI due to:\n\n   * The presence of a cardiac pacemaker, defibrillator, or other implanted metallic or electronic device which is considered MRI unsafe;\n   * Severe claustrophobia;\n   * Inability to lie flat for the duration of the study;\n   * Metallic implant or device in the pelvis that might distort the local magnetic field and compromise quality of MRI;\n   * Any other reason as determined by the investigator or treating physician.\n8. Patients with an I-PSS score \\>20 as defined by any pre-treatment IPSS questionnaire.\n9. Patients with a prior history of transurethral resection of the prostate, TURP, Urolift, or other similar trans-urethral LUTS management procedure within the last 6 months.\n10. Patients with a prior history of severe urethral stricture.\n11. Patients with a prior history of pelvic irradiation.\n12. Patients unable to meet dosimetric constraints\n13. Patients with a prior history of non-cutaneous solid malignancy within the last 5 years.\n14. Patients with a history of active and uncontrolled inflammatory bowel disease.\n15. Patients who are unable to comply with follow-up visits and treatment plans.",{"count":88,"type":20},58,[55],"The goal of this clinical trial is to determine the safety of stereotactic body radiation therapy (SBRT) microboost technique in patients with low to intermediate risk prostate cancer. The main question it aims to answer is: Is microboost SBRT with whole gland de-escalation both safe and effective in managing patients with low to intermediate-risk prostate cancer while maintaining acceptable toxicity levels? All patients will receive microboost SBRT at a dose of 45 Gy delivered in 5 fractions in up to 4 MRI-defined lesions. Patients (Arm 1) with highest grade disease in the microboost target lesion in the absence of GG2-3 beyond the microboost target (only GG1 disease can be present outside of the microboost region) will receive whole gland de-escalation at a dose of 30 Gy delivered in 5 fractions. Patients (Arm 2) with highest grade disease outside of the target lesion will receive whole gland de-escalation at a dose of 35 Gy delivered in 5 fractions. Participants will be treated every other day over a two week period and then follow up after radiation treament for up to 5 years. Participants will be asked to complete questionnaires and provide blood and urine samples for research purposes.",[62,26],[93],"Localized prostate cancer","2026-06-08",{"date":96,"type":35},"2026-06-12",{"date":98,"type":20},"2026-09",{"date":100,"type":20},"2035-01",{"name":102,"class":42},"Georgetown University",{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":21,"phases":112,"briefSummary":113,"conditions":114,"keywords":115,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":43},"100490408","two-fraction-hdr-monotherapy-for-localized-prostate-cancer-100490408","NCT05665738","Two-fraction HDR Monotherapy for Localized Prostate Cancer","Two-fraction High Dose Rate Brachytherapy as Monotherapy Delivered Three Hours Apart in Localized Prostate Cancer: A Pilot Study","Inclusion Criteria:\n\n1. Participants must have histologically or cytologically confirmed diagnosis of prostate adenocarcinoma.\n2. National Comprehensive Cancer Network low to intermediate risk stratification.\n3. No prior treatment for prostate cancer and no prior androgen deprivation therapy.\n4. Age \\>=18 years.\n5. Eastern Cooperative Oncology Group (ECOG) performance status \\\u003C2 (Karnofsky \\>60%.\n6. Eligible to undergo High dose rate (HDR) brachytherapy as monotherapy as determined by the treating radiation oncologist.\n7. Ability to understand and the willingness to sign a written informed consent document.\n8. Human immunodeficiency virus (HIV)-infected individuals on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n9. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n10. Individuals with a history of hepatitis C virus (HCV) 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.\n11. Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n\nExclusion Criteria:\n\n1. Any prior treatment for prostate cancer.\n2. Any prior androgen deprivation therapy.\n3. Is currently receiving any other investigational agents.\n4. Abnormal pre-brachytherapy assessment raising concern for undergoing HDR brachytherapy procedure.\n5. Contraindications to general anesthesia.\n6. Contraindications to radiotherapy.\n7. Prior cryosurgery or cryotherapy to the prostate.\n8. Prior transurethral resection of the prostate within the previous 6 months.",{"count":111,"type":20},17,[23],"This is a single center single arm prospective pilot study investigating the safety of high dose rate (HDR) brachytherapy as monotherapy delivered in 2 fractions 3 hours apart. HDR monotherapy has been established as safe and effective in this context, however previous studies have delivered 2 fractions on separate days, or at least 6 hours apart. Clinically, this regimen, if shown to be safe and effective in future studies, has the potential to reduce operative resources and logistical stresses on brachytherapy departments.",[63,26],[116,117,118],"Brachytherapy","Radiotherapy","High Dose Rate","2026-06-04",{"date":121,"type":35},"2026-06-05",{"date":123,"type":35},"2024-09-11",{"date":125,"type":20},"2029-02-28",{"name":127,"class":42},"University of California, San Francisco",{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":21,"phases":137,"briefSummary":139,"conditions":140,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":144,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},"100442721","early-phase-1-immunological-effects-of-vitamin-d-replacement-among-blackafrican-american-prostate-cancer-patients-100442721","NCT05045066","Immunological Effects of Vitamin D Replacement Among Black\u002FAfrican American Prostate Cancer Patients","MC210501 Differences in Immunological Effects of Vitamin D Replacement Among Black\u002F African American (AA) Prostate Cancer Patients With Localized Versus Metastatic Disease","Inclusion Criteria:\n\n* Pre-Registration:\n\n  * African American males, age \\>= 18 years\n  * Patients with a previous history of localized or metastatic or locally recurrent prostate cancer\n* Registration:\n\n  * Patients with Vitamin D levels below 30 ng\u002Fml\n\nExclusion Criteria:\n\n* Pre-Registration:\n\n  * Known hypersensitivity to vitamin D\n  * End stage renal failure on dialysis\n  * Liver cirrhosis\n  * Currently taking a vitamin D or multivitamin supplement, that has more than 400 IU\u002F10mcg of vitamin D daily for the past month\n  * Legal inability or restricted legal ability, medical or psychological conditions not allowing proper study completion or informed consent signature\n  * Chemotherapy or surgery or radiation within the last 3 weeks prior to blood collection\n  * History of hypercalcemia\n* Registration:\n\n  * Chemotherapy or surgery or radiation within the last 3 weeks prior to blood collection",{"count":136,"type":20},220,[138],"EARLY_PHASE1","This early phase I is to find out how common vitamin D insufficiency is among African American patients with a history of prostate cancer that has not spread to other parts of the body (localized) or has spread to other places in the body (metastatic) and how vitamin D insufficiency affects the immune system. This study also aims to find out if replacing vitamin D results in normalization of the immune function. Information from this study may benefit prostate cancer patients by identifying vitamin D insufficiency which in several studies had been found to contribute to more aggressive prostate cancers.",[26,141,142,143],"Stage IV Prostate Cancer AJCC v8","Locally Recurrent Prostate Carcinoma","Metastatic Prostate Carcinoma",{"date":94,"type":35},{"date":146,"type":35},"2021-12-29",{"date":148,"type":20},"2029-08-31",{"name":78,"class":42},2,{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":16,"minAge":159,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":21,"phases":162,"briefSummary":163,"conditions":164,"keywords":165,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":178},"100516364","phase-2-psma-guided-ablation-of-the-prostate-100516364","NCT06003556","PSMA-Guided Ablation of the Prostate","PSMA-Guided Ablation of the Prostate: A Multicenter Randomized Controlled Trial","P-GAP","Inclusion Criteria:\n\n1. Age \\> 50\n2. Clinical stage \\\u003C T2b\n3. PSA \\\u003C 15\n4. Combined targeted and systematic MRI-guided biopsy shows unilateral Gleason Grade Group 2 or 3 prostate cancer\n\nExclusion Criteria:\n\n1. Unable to obtain consent\n2. Weight \\>250 kg (weight limitation of scanners)\n3. Unable to lie flat for 30 minutes to complete the PET imaging\n4. Lack of intravenous access\n5. eGFR \\\u003C 40 mL\u002Fmin\u002F1.73 m2 and\u002For a history of a severe reaction to CT contrast\n6. Prior androgen deprivation therapy or radiation therapy to prostate gland","50 Years",{"count":161,"type":20},138,[55],"The goal of this phase 2 multicenter randomized controlled trial is to study the accuracy of second generation prostate specific membrane antigen (PSMA) positron emission tomography (PET; utilizing 18F-PSMA-1007) compared to standard of care multiparametric MRI and MRI targeted-prostate biopsy for staging in patients diagnosed with unilateral prostate cancer who are eligible for focal therapy.\n\nThe main question it aims to answer is:\n\nCan PSMA PET improve diagnostic accuracy for the primary staging of Prostate Cancer for patients undergoing focal therapy thereby reducing residual and recurrence disease?\n\nParticipants who are eligible by current standard of care diagnostic workup will undergo 1:1 randomization to PSMA PET scan or no further imaging. Those diagnosed with bilateral disease by PSMA PET will be ineligible for focal therapy and be referred for radical therapy. Men with unilateral disease on PSMA PET and those randomized to no further imaging will then undergo focal therapy. All men undergoing focal therapy will receive PSMA PET, MRI, and combined targeted and systematic biopsy 12 months after ablation. The primary outcome will be the detection of Gleason Grade Group 2 or higher prostate cancer in men 12 months after hemigland ablation.",[62,26],[62,166,167,168],"PSMA Pet","Focal Therapy","Localized Prostate Cancer","2026-06-02",{"date":171,"type":35},"2026-06-03",{"date":173,"type":35},"2024-04-02",{"date":175,"type":20},"2029-02-26",{"name":177,"class":42},"University of Alberta",4,{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":185,"eligibilityCriteria":186,"healthyVolunteers":11,"sex":16,"minAge":187,"maxAge":188,"enrollmentInfo":189,"targetDuration":4,"studyType":21,"phases":190,"briefSummary":191,"conditions":192,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":150},"100554521","golf-recreational-exercise-for-enhanced-survivorship-in-prostate-cancer-survivors-100554521","NCT06500169","Golf Recreational Exercise for Enhanced Survivorship in Prostate Cancer Survivors","Golf Recreational Exercise for Enhanced Survivorship in Prostate Cancer Survivors Undergoing Hormone Therapy (GREENS)","GREENS","Inclusion Criteria:\n\n* First time, primary diagnosis of prostate cancer (PCa)\n* Currently receiving androgen deprivation therapy (ADT) and\u002For androgen receptor blocker) for more than 6 months\n* Older adult male: 55-85 years old\n* The ability to stand independently without external support\n* No or minimal golf experience (played \\\u003C 5 times in the past 10 years)\n* English speaking\n\nExclusion Criteria:\n\n* Second cancer diagnosis (excluding non-invasive skin cancers) or bone metastases\n* Prostatectomy less than 6 months prior to study enrollment (prostatectomy is not a requirement for study entry)\n* Symptomatic cardiovascular disease, active angina, uncontrolled hypertension (systolic blood pressure (SBP) \\> 160 or diastolic blood pressure (DBP) \\> 90, high resting pulse heart rate (HR) \\> 90), symptomatic orthostatic hypotension\n* Unstable asthma, exacerbated chronic obstructive pulmonary disease (COPD\\]\n* History of injury or orthopedic operation within the last 6 months\n* Movement disorders (e.g., Parkinson's disease (PD) or other neurological disorders), hemiparesis or paraparesis\n* Severe vision or hearing problems","55 Years","85 Years",{"count":5,"type":20},[23],"This clinical trial evaluates a golf recreational exercise program for enhancing survivorship in underrepresented prostate cancer survivors. Golf is a multimodal recreational activity that requires participants to utilize all muscle groups to perform the golf swing, walk over hilly and uneven terrain, maintain balance during putting and squat-like tasks. Physical activity and exercise are beneficial to physical function, cognitive function, psychosocial health, and overall quality of life during prostate cancer survivorship. These aspects of health are impacted by prostate cancer treatment, especially androgen deprivation therapy. Additionally, supervised, group-based activity programs facilitate participation in physical activity. Researchers want to examine the changes in functional abilities, psychosocial health, and quality of life following participation in in a golf program designed for prostate cancer survivors.",[26,193,194,28,195],"Locally Advanced Prostate Carcinoma","Stage I Prostate Cancer American Joint Committee on Cancer (AJCC) v8","Stage III Prostate Cancer AJCC v8","2026-05-29",{"date":171,"type":35},{"date":199,"type":35},"2023-09-01",{"date":201,"type":20},"2027-12-31",{"name":203,"class":42},"University of Southern California",{"id":205,"slug":206,"hasResults":11,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":211,"targetDuration":4,"studyType":21,"phases":213,"briefSummary":215,"conditions":216,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":43},"100572444","phase-4-testosterone-replacement-therapy-for-the-treatment-of-low-testosterone-in-hypogonadal-men-with-localized-prostate-cancer-on-active-surveillance-100572444","NCT06733350","Testosterone Replacement Therapy for the Treatment of Low Testosterone in Hypogonadal Men With Localized Prostate Cancer on Active Surveillance","Investigating the Effect of Testosterone Replacement Therapy Among Hypogonadal Men With Localized Prostate Cancer on Active Surveillance","Inclusion Criteria:\n\n* Men aged ≥ 18 years\n* Men with localized prostate cancer are eligible for active surveillance (National Comprehensive Cancer Network \\[NCCN\\] very low, low, and intermediate favorable risk group)\n* Participant must understand the investigational nature of this study and sign an independent ethics committee\u002Finstitutional review board approved written informed consent form prior to receiving any study related procedure\n\nExclusion Criteria:\n\n* Patients with NCCN intermediate unfavorable, high risk, or very high-risk localized prostate cancer\n* For men being considered for Group 2 (TRT), Patients with contraindications to TRT, which include,\n\n  * Locally advanced or metastatic prostate cancer\n  * Male breast cancer\n  * Men with an active desire to have children\n  * Hematocrit levels \\> 54% or baseline hematocrit of 48-50%\n  * Uncontrolled or poorly controlled congestive heart failure\n  * IPSS (International Prostate Symptom Score) score \\> 19\n  * Family history of venous thromboembolism\n* Unwilling or unable to follow protocol requirements\n* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to participate in the study",{"count":212,"type":20},600,[214],"PHASE4","This phase IV trial studies the effects of testosterone replacement therapy (TRT) on treatment outcomes in hypogonadal men with prostate cancer that has not spread to other parts of the body (localized) and who are on active surveillance (AS). AS in prostate cancer involves closely watching the patient's condition through regular physical exams and blood tests, but not giving treatment unless there are changes in test results. It can be a practical alternative to treatment in localized prostate cancer. Hypogonadal men have low testosterone associated with symptoms such as low libido and erectile problems. TRT can be used to treat hypogonadism by increasing testosterone levels, which may improve associated symptoms. TRT is often not used in men with prostate cancer due to concerns it may lead to the cancer growing or spreading. This may lead hypogonadal men to have a poor quality of life or to discontinue AS. TRT may improve treatment and quality of life outcomes in hypogonadal men with localized prostate cancer on active surveillance.",[26,27,28,195],"2026-05-13",{"date":219,"type":35},"2026-05-14",{"date":221,"type":35},"2025-01-15",{"date":223,"type":20},"2029-01-15",{"name":225,"class":42},"Roswell Park Cancer Institute",{"id":227,"slug":228,"hasResults":11,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":4,"eligibilityCriteria":232,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":233,"targetDuration":4,"studyType":21,"phases":235,"briefSummary":236,"conditions":237,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":43},"100627997","phase-2-assessing-efficacy-of-neoadjuvant-adt-in-localized-high-risk-prostate-cancer-patients-utilizing-18f-flotufolastat-psma-petct-100627997","NCT07455903","Assessing Efficacy of Neoadjuvant ADT in Localized High-Risk Prostate Cancer Patients Utilizing 18F-Flotufolastat PSMA PET\u002FCT","Assessing the Efficacy of Neoadjuvant Androgen Deprivation Therapy (ADT) Utilizing 18F-Flotufolastat PSMA PET\u002FCT in Patients With High-Risk Localized Prostate Cancer (LHRPC)","Inclusion Criteria:\n\n* Signed informed consent must be obtained prior to participation in the study.\n* Males aged ≥18 years.\n* ECOG performance status ≤ 1\n* Histologically confirmed adenocarcinoma of the prostate in a patient amenable to radical prostatectomy\n* Pathologically proven prostate adenocarcinoma with ≥ 1 High-risk feature based on NCCN guidelines.\n\n  1. cT3-cT4\n  2. International Society of Urological Pathology (ISUP) Grade group 4 (Gleason score 8) or grade group 5 (Gleason score 9-10)\n  3. PSA \\>20 ng\u002FmL\n* Clinically negative lymph nodes as established by PSMA PET\u002FCT imaging. Patients who are node positive by PSMA PET\u002FCT (e.g., N1), but whose nodes do not meet traditional size criteria for positivity (e.g., they measure ≥ 10mm on either the CT or MRI portion of the PET or on a dedicated CT or MRI) will not be considered N1 and would be eligible for this study.\n* Patient is willing to use barrier-method of contraception along with another effective contraceptive method if engaged in sexual activity with a pregnant person or individual of childbearing potential (until 1 week after completing 18F-flotufolastat PSMA PET\u002FCT Scans.\n* Clinical laboratory values during screening:\n\n  1. Hemoglobin ≥ 10.0 g\u002FdL\n  2. Absolute neutrophil count (ANC) ≥ 1.8 × 10⁹\u002FL\n  3. Platelets ≥ 100 × 10⁹\u002FL\n\nExclusion Criteria:\n\n* Known allergies, hypersensitivity, or intolerance to 18F-flotufolastat.\n* Unable to receive androgen deprivation therapy.\n* Prostate cancer with significant neuroendocrine or other rare variant pathology\n* Evidence of metastatic disease involving bone, viscera, or lymph nodes superior to the bifurcation of the common iliac arteries on PSMA PET\u002FCT\n* Renal impairment (glomerular filtration rate \\\u003C30 mL\u002Fmin)\n* History of prior radiation therapy for prostate cancer\n* Any of the following within 6 months prior to the first dose of study treatment: severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, clinically significant ventricular arrhythmias, or New York Heart Association Class II to IV heart disease.\n* Uncontrolled severe hypertension, persistent uncontrolled diabetes, oxygen-dependent lung disease, chronic liver disease, or untreated HIV infection.\n* Other malignancies other than prostate cancer in the past 5 years\n\n  a. Cured basal cell or squamous cell skin cancers can be enrolled.\n* Severe or uncontrolled concurrent infections are not eligible.\n* Treated with concomitant cytotoxic cancer therapy for any other primary site.\n* Patients who are unable to complete the study requirements of 2nd PSMA imaging or surgery for the primary endpoints.\n* Any condition that, in the opinion of the investigator, would preclude participation in this study.",{"count":234,"type":20},50,[55],"The purpose of this research study is to test the efficacy of ADT on prostate-specific membrane antigen (PSMA), a marker of prostate cancer, before and after scheduled ADT. Follow up will be 48 months your prostate removal to do a blood test and log if any new or worsening symptoms have occurred as a part of your standard-of-care (SOC).",[62,26],"2026-05-12",{"date":217,"type":35},{"date":241,"type":35},"2026-04-23",{"date":243,"type":20},"2030-10",{"name":245,"class":42},"Baptist Health South Florida",{"id":247,"slug":248,"hasResults":11,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":4,"eligibilityCriteria":252,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":253,"targetDuration":4,"studyType":21,"phases":255,"briefSummary":256,"conditions":257,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":43},"100249488","early-phase-1-pilot-study-of-mr-imaging-with-pyruvate-13c-to-detect-high-grade-prostate-cancer-100249488","NCT02526368","Pilot Study of (MR) Imaging With Pyruvate (13C) to Detect High Grade Prostate Cancer","A Pilot Study of Magnetic Resonance (MR) Imaging With Hyperpolarized Pyruvate (13C) to Detect High Grade Localized Prostate Cancer","Inclusion Criteria:\n\n* Biopsy-proven adenocarcinoma of the prostate. Biopsy may be performed outside of University of California, San Francisco (UCSF), if detailed results of sextant biopsy are available. For Cohort A only, a minimum of 20 participants out of a planned enrollment of 50 patients must have high-risk disease as defined by primary Gleason score of 4 or 5 on prior prostate biopsy.\n* Cohort A only: Planned radical prostatectomy at UCSF within 12 weeks following protocol MRI\u002FMRSI.\n* Cohort B only: HIFU focal therapy completed within 18 months of protocol MRI\u002FMRSI, and planned systematic and MR-guided biopsy at UCSF within 12 weeks following protocol MRI\u002FMRSI.\n* The participant is able and willing to comply with study procedures and provide signed and dated informed consent\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n\nExclusion Criteria:\n\n* Participants who because of age less than 18 years old, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.\n* Participants unwilling or unable to undergo MR imaging, including patients with contraindications to MRI, such as cardiac pacemakers or non-compatible intracranial vascular clips.\n* Participants who cannot tolerate or have contra-indications to endorectal coil insertion; for example, participants with a prior abdominoperineal resection of the rectum or latex allergy.\n\nNote: The use of an endorectal coil may be waived at the discretion of the Principal Investigator upon review of available imaging with radiology, in which case this exclusion criterion will not apply.\n\n* Patients with contra-indications to injection of gadolinium contrast; for example patients with prior documented allergy or those with inadequate renal function.\n* Metallic hip implant or any other metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging.\n* Cryosurgery, surgery for prostate cancer, prostatic or pelvic radiotherapy prior to study enrollment. For Cohort B, HIFU focal therapy is allowed. No limit on number of prior prostate biopsies; prior transurethral prostatic resection (TURP) is not allowed.\n* Current or prior androgen deprivation therapy. For Cohort A, a history of use of a 5-alpha reductase inhibitor is allowed, provided it was discontinued at least one month prior to study entry. For cohort B, a history of use of 5-α reductase inhibitor is allowed, provided it is discontinued at least 14 days to protocol MRI\u002FMRSI.\n* Poorly controlled hypertension, with blood pressure at study entry \\> 160\u002F100; the addition of anti-hypertensives to control blood pressure is allowed for eligibility determination.\n* Congestive heart failure or New York Heart Association (NYHA) status \\>= 2.\n* A history of clinically significant electrocardiography (EKG) abnormalities, including QT prolongation, a family history of prolonged QT interval syndrome, or myocardial infarction (MI) within 6 months of study entry; patients with rate-controlled atrial fibrillation\u002Fflutter will be allowed on study.",{"count":254,"type":20},80,[138],"This pilot clinical trial studies how well magnetic resonance spectroscopic imaging (MRSI) with hyperpolarized carbon 13 (13C) pyruvate alone or in combination with 13C 15N2 Urea works in finding prostate cancer that exhibits poorly differentiated or undifferentiated cells (high-grade) and that is restricted to the site of origin, without evidence of spread (localized) in patients undergoing radical prostatectomy. Diagnostic procedures, such as MRSI with hyperpolarized carbon (13C) pyruvate, may aid in the diagnosis of prostate cancer and in discriminating high-grade from low-grade prostate cancer and benign adjacent prostate tissue",[62,26],"2026-04-24",{"date":260,"type":35},"2026-04-30",{"date":262,"type":35},"2016-03-22",{"date":264,"type":20},"2026-12-31",{"name":266,"class":42},"Ivan de Kouchkovsky, MD",{"id":268,"slug":269,"hasResults":11,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":4,"eligibilityCriteria":273,"healthyVolunteers":11,"sex":16,"minAge":274,"maxAge":188,"enrollmentInfo":275,"targetDuration":4,"studyType":21,"phases":276,"briefSummary":277,"conditions":278,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":43},"100546042","accuracy-of-18f-rhpsma-73-pet-mri-for-prediction-of-lymph-node-metastasis-in-localized-high-risk-prostate-cancer-100546042","NCT06389786","Accuracy of 18F-rhPSMA-7.3 PET\u002F MRI for Prediction of Lymph Node Metastasis in Localized High-Risk Prostate Cancer","MC230504 Safe Omission of Pelvic Lymph Node Dissection (SOuND ) During Radical Prostatectomy: Diagnostic Accuracy of rhPSMA-7.3(18F) PET\u002FCT, mpMRI and Patient Clinical Factors to Predict Lymph Node Metastasis","Inclusion Criteria:\n\n* Male subjects ≥ 30 and ≤ 85 years old\n* Primary diagnosis of prostate cancer selected for surgical intervention (radical prostatectomy with extended lymph node dissection)\n* Primary diagnosis of untreated American Urological Association (AUA) guidelines high-risk localized prostate cancer, hormone-naïve prostate cancer via contrast enhanced prostate MRI + tissue sampling\n* Planned elective radical prostatectomy with extended pelvic lymph node dissection\n* Clinical oligometastatic disease with ≤ 3 nodes positive on preoperative standard of care imaging of prostate region within 6 months of surgery\n* Patient agrees to comply with the investigator instructions\n* Patient agrees to comply with the follow-up surveillance schedule\n* Have ability to provide full written consent\n\nExclusion Criteria:\n\n* High-risk cancer planned for neoadjuvant therapy\n* Patients with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to initial screening, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study\n* Patients that have had prior hormonal therapy such as Lupron or oral antiandrogens ≤ 12 weeks prior to registration\n* Clinical oligometastatic disease with \\> 3 nodes positive preoperative standard of care imaging of prostate region\n* Previous history of pelvic radiation\n* Patients with obesity defined as body mass index (BMI) \\> 40 kg\u002Fm\\^2\n* History of prior laparoscopic inguinal hernia repair with mesh\n* Scheduled at the time of screening to undergo chemotherapy, radiation, hormone therapy, or open surgery during the study period\n* Inability to lie still for 75 minutes during 18F-rhPSMA-7.3 PSMA PET-MRI imaging\n* Any neurologic disorder or psychiatric disorder that might confound postsurgical assessments\n* Has any condition(s), which seriously compromises the subject's ability to participate in this study, sign consent, or has a known history of poor adherence with medical treatment\n* Received administration of an investigational drug within 30 days prior to study registration, and\u002For has planned administration of another investigational product or procedure during participation in this study","30 Years",{"count":234,"type":20},[23],"This clinical trial evaluates the use of an imaging scan (18F-rhPSMA-7.3 positron emission tomography \\[PET\\]\u002Fmagnetic resonance imaging \\[MRI\\]) for identifying patients who are at risk of having their disease spread to the lymph nodes in those undergoing radical prostatectomy for prostate cancer that has not spread to other parts of the body (localized). Prostate specific membrane antigen (PSMA) PET\u002Fcomputed tomography (CT) has emerged as an option to stage newly diagnosed high risk prostate cancer patients. PSMA PET\u002FCT has demonstrated improved diagnostic accuracy for identifying metastasis. PET is procedure in which a small amount of radioactive glucose (sugar) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is used. Because cancer cells often use more glucose than normal cells, the pictures can be used to find cancer cells in the body. MRI is procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. These pictures can show the difference between normal and diseased tissue. This study may help researchers learn whether 18F-rhPSMA-7.3 PET\u002F MRI may improve predicting which patients are at risk of lymph node metastases and who are suitable candidates for pelvic lymph node dissection in patients with localized high-risk prostate cancer undergoing radical prostatectomy.",[26,279,27,28,195,280],"Oligometastatic Prostate Carcinoma","Stage IVA Prostate Cancer AJCC v8","2026-04-01",{"date":283,"type":35},"2026-04-06",{"date":285,"type":35},"2024-06-11",{"date":287,"type":20},"2027-05-31",{"name":78,"class":42},{"id":290,"slug":291,"hasResults":11,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":295,"eligibilityCriteria":296,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":297,"targetDuration":4,"studyType":21,"phases":299,"briefSummary":301,"conditions":302,"keywords":306,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":43},"100597119","phase-1-comparison-of-177lu-psma-617-and-225ac-psma-617-100597119","NCT07054346","Comparison of 177Lu-PSMA-617 and 225Ac-PSMA-617","Comparison of 177Lu-PSMA-617 and 225Ac-PSMA-617 in a Prostatectomy Model (LUTACT Trial)","LUTACT","Inclusion Criteria:\n\n1. Histologically confirmed prostate adenocarcinoma.\n2. Willing to undergo prostatectomy with or without lymph node dissection, and candidate for prostatectomy as determined by urologic oncology.\n3. High-risk disease as defined as meeting 1 or more of the 3 following criteria:\n\n   1. Gleason score of 4+5 disease or higher.\n   2. Pelvic nodal metastases on PSMA PET.\n   3. Extracapsular extension or seminal vesicle invasion on MRI.\n4. No evidence of distant metastatic disease as determined by PSMA PET. Nodal disease below the iliac bifurcation (clinical stage N1) is allowed.\n5. Maximum Standardized Uptake Value (SUVmax) in the primary tumor greater than 10 on PSMA PET using Gallium-68 (68Ga)-PSMA-11 or piflufolastat F 18 (18F-DCFPyL).\n6. Target tumor in the prostate measuring greater than 1.5 cm on MRI.\n7. Age ≥18 years.\n8. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%),\n9. Demonstrates adequate organ function as defined below:\n\n   1. Platelets ≥100,000\u002FmcL, independent of transfusions or growth factors within 3 months of treatment start.\n   2. Hemoglobin ≥10 g\u002FdL, independent of transfusions or growth factors within 3 months of treatment start.\n   3. Absolute Neutrophil Count (ANC) ≥1,500\u002Fmicroliter (mcL).\n   4. Creatinine clearance Glomerular filtration rate (GFR) ≥ 60 mL\u002Fmin\u002F1.73 m\\^2 , calculated using the Cockcroft-Gault equation.\n   5. Albumin ≥2.5 g\u002FdL.\n   6. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤3.0 x ULN.\n   7. Total bilirubin (TBIL) ≤2 x the institutional upper limit of normal (ULN). For participants with known Gilbert's Syndrome ≤3 x ULN is permitted.\n10. Ability to understand and the willingness to sign a written informed consent document.\n11. Participants must provide consent to comply to recommended radioprotection precautions during study.\n12. Participants must use adequate contraception and not donate sperm while on study drug and for at least 14 weeks after the last study treatment.\n\nExclusion Criteria:\n\n1. Has received prior prostate cancer therapy.\n\n   a. Prior 5-alpha reductase inhibitors (e.g. finasteride, dutasteride) allowed if discontinued at least 3 weeks prior to treatment start.\n2. Has participated in a study of an investigational therapeutic product and received study treatment or used an investigational device within four weeks of the first dose of treatment.\n3. Dry mouth that impacts the eating of food (i. e. requiring mouthwash prior to eating).\n4. Concurrent serious (as determined by the principal investigator) medical conditions including but not limited to New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, known active hepatitis B or C or other significant co-morbid conditions that in the opinion of the investigator would impair study participation or cooperation.\n5. Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, participants with a prior history of malignancy that has been adequately treated and who have been disease free, treatment free for more than 3 years prior to randomization, or participants with adequately treated non-melanoma skin cancer, superficial bladder cancer are eligible.\n6. Individuals with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.\n7. Prior external beam radiation therapy (EBRT) to the prostate or prostate bed.\n\nAdditional exclusion criteria applicable only to participants undergoing intraarterial administration of PSMA RLT:\n\n1. Severe allergy to iodinated contrast.\n2. Severe atherosclerosis from prior CT imaging study, or greater than 10 pack-year smoking history if no prior imaging available.",{"count":298,"type":20},45,[300],"PHASE1","There is evidence that Actinium-225 Prostate-Specific Membrane Antigen (225Ac-PSMA) has a potentially higher level of efficacy than 177 Lutetium Prostate-Specific Membrane Antigen (177Lu-PSMA) as a radioligand therapy. This single center, pilot study will compare differences in the mechanisms of actinium-225 and lutetium-177 radioligand therapies (RLT) in participants with high or very high risk localized or locoregional prostate cancer planning on undergoing a prostatectomy.",[62,303,304,26,305],"Prostate Cancer (Diagnosis)","High-risk Prostate Cancer","Very High Risk Prostate Carcinoma",[307],"Radioligand Therapy","2026-03-26",{"date":281,"type":35},{"date":311,"type":35},"2025-07-08",{"date":313,"type":20},"2028-04-30",{"name":315,"class":42},"Thomas Hope",{"id":317,"slug":318,"hasResults":11,"nctId":319,"briefTitle":320,"officialTitle":321,"acronym":322,"eligibilityCriteria":323,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":324,"targetDuration":4,"studyType":326,"phases":4,"briefSummary":327,"conditions":328,"keywords":332,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":343,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":351},"100580196","online-adaptive-stereotactic-body-radiotherapy-for-localized-prostate-cancer-x-smile-100580196","NCT06834152","Online Adaptive Stereotactic Body Radiotherapy for Localized Prostate Cancer (X-SMILE)","Online Adaptive Stereotactic Body Radiotherapy for Localized Prostate Cancer in Patients With Lower Urinary Tract Symptoms and\u002For Prostate Hyperplasia (X-SMILE)","X-SMILE","Inclusion Criteria:\n\n* histologically confirmed localized prostate cancer\n* planned treatment is SBRT according to standard of care and consists of definitive CT or MRI online adaptive SBRT of the prostate according to the PACE trial which includes a total dose to clinical target volume 1 (CTV1, i.e. prostate and proximal 1 cm of the seminal vesicle) of 40.0 Gy in 5 weekly fractions (single dose of 8.0 Gy) and total dose to planning target volume 1 (PTV1) of 37.5 Gy in 5 weekly fractions (single dose of 7.5 Gy) with a compromise for bowel sparing allowed. For patients with unfavorable intermediate to very high-risk disease (according to NCCN guidelines) a total dose to the planning target volume 2 (PTV2, i.e. proximal 1-2 cm of the seminal vesicle) of 32.5 Gy in 5 weekly fractions (single dose of 6.5 Gy) will be delivered.\n* intermediate to (very) high risk localized prostate cancer (≤ cT3a and Gleason score ≤ 9 and\u002For PSA ≤ 20 ng\u002Fml)\n* prostate volume \\> 60 cc and\u002For IPSS \\> 12;\n\nExclusion Criteria:\n\n* Very high risk localized prostate cancer with indication for ADT and ARPI (i.e. Gleason ≥ 8 and cT3a)\n* Involvement of seminal vesicles (cT3b)\n* Contraindications against definitive CT or MRI-adaptive radiotherapy of the prostate, e.g. inflammatory bowel disease (IBD); previous radiotherapy in the pelvis, previous local radiotherapy of the prostate, contraindication for MRI or CT;\n* Patients with severe genitourinary symptoms (e.g. recent urinary retention ≥ grade 3 according CTCAE v.5.0);\n* Lymph node metastases or distant metastases (i.e. no localised prostate cancer);\n* Participation in a clinical trial which might influence the results of this project.",{"count":325,"type":20},75,"OBSERVATIONAL","The aim of this phase II international multicenter study is to evaluate the safety, feasibility, and efficacy of CT or MRI-adaptive SBRT, delivered in five weekly fractions, in patients with newly diagnosed localized prostate cancer who have lower urinary tract symptoms and\u002For prostatic hyperplasia.",[26,329,330,331],"Prostate Cancer (Adenocarcinoma)","Prostate Hyperplasia","Lower Urinary Track Symptoms",[333,334,335,336,337,338,339,340,341],"radiotherapy","SBRT","MRI","CT","stereotactic radiotherapy","localized prostate cancer","lower urinary tract symptoms","prostate hyperplasia","prostate cancer","2026-02-04",{"date":344,"type":35},"2026-02-09",{"date":346,"type":35},"2024-03-01",{"date":348,"type":20},"2031-06-30",{"name":350,"class":42},"University of Zurich",3,{"id":353,"slug":354,"hasResults":11,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":358,"eligibilityCriteria":359,"healthyVolunteers":11,"sex":360,"minAge":17,"maxAge":4,"enrollmentInfo":361,"targetDuration":4,"studyType":326,"phases":4,"briefSummary":362,"conditions":363,"keywords":364,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":43},"100531528","multi-omic-approach-to-study-hdr-brachytherapy-for-favorable-risk-and-low-tier-intermediate-risk-prostate-cancer-100531528","NCT06200974","Multi-omic Approach to Study HDR Brachytherapy for Favorable Risk and Low Tier Intermediate Risk Prostate Cancer","Multi-omic Approach to Study High Dose Rate (HDR) Brachytherapy for Favorable Risk and Low Tier Intermediate Risk Prostate Cancer","BrachyTRACKS","Inclusion Criteria:\n\n* Favorable risk and intermediate-risk prostate cancer with estimated life expectancy of at least 10 years.\n* Clinical stage T1c-T2b, PSA \\\u003C 20, Gleason \\\u003C 8\n* ECOG 0-1\n* Low tier intermediate-risk prostate cancer is defined by: a single NCCN intermediate risk factor (either Gleason 7(3+4) and PSA \\\u003C 10 ng\u002Fml OR Gleason 6 and PSA 10-20 ng\u002Fml)\n* Extensive favorable-risk disease is defined as: clinical stage T1c-T2a, PSA \\\u003C 10, Gleason 6, ≥ 50% of biopsy cores containing cancer, PSA density \\> 0.2 ng\u002Fcc,\n* Selected intermediate risk patients not defined above\n\n  * T1c\u002FT2a\n  * PSA \\\u003C 10 and Gleason 4+3\n  * PSA \\> 10 (\\\u003C 20) and Gleason 3+4\n  * PSA 10-15 ng\u002Fml and Gleason 4+3 and \\\u003C 33% cores involved\n  * Max tumor length in any core 10 mm\n* No androgen deprivation therapy (ADT)\n* Signed study specific informed consent.\n\nExclusion Criteria:\n\n* Prior radical surgery for carcinoma of the prostate,\n* Prior pelvic radiation\n* Prior chemotherapy for prostate cancer,\n* Claustrophobic or unable to undergo MRI\n* Patients unsuitable for general anesthesia, on blood thinners which cannot be stopped for 24 hours, or who have contraindications to radiotherapy such as systemic sclerosis, or inflammatory bowel disease","ALL",{"count":19,"type":20},"This is an observational single-center trial for patients with localized prostate cancer suitable for High Dose Rate (HDR) brachytherapy as monotherapy. This study takes a multi-omics approach to study the mechanism of action of HDR brachytherapy through metabolomics, immunological, transcriptomics, and spectroscopic profiling. The results of this study will clarify the optimal dose for HDR prostate brachytherapy by documenting the dose-response relationship seen in the changing tumor metabolites after HDR brachytherapy and investigate the immunogenicity of HDR brachytherapy.",[26],[116,365,118,366,367,368],"TRACKS","Prostate cancer","favorable risk","intermediate risk","2026-01-29",{"date":371,"type":35},"2026-02-02",{"date":373,"type":35},"2024-02-01",{"date":375,"type":20},"2038-02-01",{"name":377,"class":42},"British Columbia Cancer Agency",{"id":379,"slug":380,"hasResults":11,"nctId":381,"briefTitle":382,"officialTitle":383,"acronym":4,"eligibilityCriteria":384,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":385,"targetDuration":4,"studyType":21,"phases":387,"briefSummary":388,"conditions":389,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":397,"locationsCount":351},"100567951","addressing-health-literacy-with-a-tailored-survivorship-care-plan-100567951","NCT06674863","Addressing Health Literacy With a Tailored Survivorship Care Plan","Addressing Health Literacy With a Tailored Survivorship Care Plan to Improve Access in Underserved African American Prostate Cancer Patients","Inclusion Criteria:\n\n* Black and African American men who are disease-free after completing primary surgery and\u002For radiation treatment for localized or oligometastatic prostate cancer between 1 to 4 years prior to enrollment. (Race\u002Fethnicity per medical records and self report)\n* Patients who are still receiving adjuvant androgen deprivation therapy following primary radiation with non-palliative intent may be included\n\nExclusion Criteria:\n\n* Dementia or cognitive impairment per provider clinical assessment\n* Unable to give informed consent in the judgement of the patient's oncology provider\n* Recurrent prostate cancer after primary treatment\n* Less than 18 years of age at the time of informed consent\n* Diagnosis of active second malignancy requiring treatment\n* Individuals who are not able to clearly understand English since the outcome measures require understanding of English",{"count":386,"type":20},150,[23],"This clinical trial compares the impact of a tailored survivorship care plan (SCP) to a standard SCP on the understanding of and access to survivorship care in black or African American patients with prostate cancer that has not spread to other parts of the body (localized) or that has spread from where it first started (primary site) to a limited number of places in the body (oligometastatic). SCPs summarize treatment history and recommendations for monitoring and maintaining health, and may also include potential long term effects of treatments received. The intention of a SCP is to help patients participate in their own health care. However, many patients have below basic levels of health literacy, meaning, they have a lower ability to obtain, communicate, process and understand basic health information and services to make health decisions. In fact, poor health literacy has been linked with worse quality of life in prostate cancer survivors. A tailored SCP includes the addition of an educational supplement based on lower reading and writing skills (low literacy) and may address health literacy barriers to understanding of treatment options and side effects. A standard SCP uses a template based on the American Society of Clinical Oncology (ASCO) guidelines for prostate cancer. A tailored SCP with low literacy educational supplements may be more effective compared to a standard SCP in improving understanding and access to survivorship care in black or African American patients with localized or oligometastatic prostate cancer.",[26,279,59],"2025-12-05",{"date":392,"type":35},"2025-12-09",{"date":394,"type":35},"2025-11-07",{"date":396,"type":20},"2030-12-31",{"name":398,"class":42},"Emory University",{"id":400,"slug":401,"hasResults":11,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":405,"eligibilityCriteria":406,"healthyVolunteers":11,"sex":16,"minAge":407,"maxAge":4,"enrollmentInfo":408,"targetDuration":4,"studyType":21,"phases":410,"briefSummary":411,"conditions":412,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":413,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":43},"100588351","feasibility-and-effect-of-wrapping-nerves-with-a-multi-layer-perinatal-tissue-allograft-during-prostatectomy-100588351","NCT06940271","Feasibility and Effect of Wrapping Nerves With a Multi-Layer Perinatal Tissue Allograft During Prostatectomy","RAP: Prospective Pragmatic Multi-Site Trial Evaluating the Feasibility and Effect of Wrapping the Cavernous Nerves With a Novel Multi-Layer Perinatal Tissue Allograft During Prostatectomy","RAP","Inclusion Criteria:\n\n* Male subjects with age ≥ 45\n* Primary diagnosis of prostate cancer selected for surgical intervention (radical prostatectomy)\n* Primary diagnosis of organ confined (i.e. localized) untreated prostate cancer\n* Planned elective radical prostatectomy with bilateral nerve sparing technique\n* Negative urinalysis within 30 days prior to date of surgery\n* Patient has no erectile dysfunction (SHIM score ≥ 19) at the time of consultation\n* Willing to comply with instruction of the investigator\n* Willing to comply with follow-up surveys\n* Ability to provide written consent\n* Negative urinary tract infection at the time of consultation\n* Interest in penetrative sexual intercourse\n\nExclusion Criteria:\n\n* High-risk cancer planned for neoadjuvant therapy, full or partial excision of neurovascular bundles\n* Unable to comply with learning and documenting penile rehabilitation, including oral 5-phosphodiesterase inhibitor use, vacuum pump therapy use, and\u002For injectable medications\n* History of \\>14 days treatment with immunosuppressants (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to initial screening, or who receive such medications during the screening period\n* Prior hormonal therapy such as Lupron or oral anti-androgens\n* Poor urinary control at baseline requiring the use of pads for leakage\n* Previous history of pelvic radiation\n* Previous history of simple prostatectomy or transurethral prostate surgery\n* Patients with obesity defined as body mass index (BMI) \\> 40 kg\u002Fm\\^2\n* History of open pelvic surgery ≤ 5 prior to registration (except for hernia repair)\n* Scheduled to undergo chemotherapy, radiation, hormone therapy, or open surgery during the study period\n* Any neurologic disorder or psychiatric disorder that might confound postsurgical assessments\n* Has any condition(s) which seriously compromises the subject's ability to participate in this study, sign consent, or has a known history of poor adherence with medical treatment\n* In the opinion of the principal investigator (PI), has a history of drug or alcohol abuse ≤ 12 months prior to registration\n* Allergic to aminoglycoside antibiotics (such as gentamicin and\u002For streptomycin)\n* Received administration of an investigational drug within 30 days prior to registration, and\u002For has planned administration of another investigational product or procedure during participation in this study","45 Years",{"count":409,"type":20},25,[23],"This clinical trial studies whether a new multi-layer perinatal tissue allograft, MLG-Complete (Trademark), can be used to improve complications after nerve-sparing robot-assisted radical prostatectomy (RARP) in patients with prostate cancer that has not spread to other parts of the body (localized). Two major complications that can happen after complete surgical removal of the prostate (radical prostatectomy) include erectile dysfunction and urinary incontinence, both of which greatly affect a patient's quality of life and social well-being. The goal of nerve-sparing radical prostatectomy is to preserve erectile and urinary function, but damage to the surrounding nerves and blood vessels can still occur causing the patient to experience the complications. An allograft is the transplant of an organ, tissue, or cells from one individual to another individual of the same species who is not an identical twin. The MLG-Complete allograft is made up of perinatal tissue and is placed on the nerve bundles during a nerve-sparing RARP. It is meant to serve as a barrier and provide coverage to the nerve bundles from the surrounding environment, which may improve post-nerve-sparing RARP complications.",[26,27,28,195],{"date":414,"type":35},"2025-11-10",{"date":416,"type":35},"2025-08-14",{"date":418,"type":20},"2030-07-30",{"name":78,"class":42},{"id":421,"slug":422,"hasResults":11,"nctId":423,"briefTitle":424,"officialTitle":425,"acronym":426,"eligibilityCriteria":427,"healthyVolunteers":428,"sex":16,"minAge":17,"maxAge":429,"enrollmentInfo":430,"targetDuration":4,"studyType":21,"phases":432,"briefSummary":433,"conditions":434,"keywords":437,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":442,"startDateStruct":444,"completionDateStruct":446,"leadSponsor":448,"locationsCount":43},"100499706","ultra-hypofractionnated-radiotherapy-with-hdr-brachytherapy-boost-100499706","NCT05786742","Ultra Hypofractionnated Radiotherapy With HDR Brachytherapy Boost.","ULTRA-HYPO Fractionated (UHF) Compared to Moderate-HYPO Fractionated (MHF) Prostate IGRT With HDR Brachytherapy BOOST : A Phase 1-2 Study.","HYPO-5","Inclusion Criteria:\n\n* Biopsy proven Prostate adenocarcinoma\n* Stage T1c, T2 (Annex 2)\n* Stage Nx or N0\n* Stage Mx or M0\n* PSA \\\u003C 20ng\u002Fml\n* Gleason Score 6 or 7\n* Having the ability to sing a written consent\n\nExclusion Criteria:\n\n* Age \\\u003C 18ans\n* Clinical Stage T3 or T4\n* Stage N1\n* Stage M1\n* PSA \\> 20\n* Gleason Score 8 to 10\n* IPSS Score \\> 20 alpha-blocking medication.\n* Prior pelvic radiotherapy.\n* History of active collagenosis (Lupus, Sclerodermia, Dermatomyosis)\n* Past history of Inflammatory Bowell Disease\n* Bilateral hip prosthesis",true,"95 Years",{"count":431,"type":20},205,[23],"Phase 1-2 study, comparing ultra-hypofractionnated (UH) to a moderately hypofractionnated (MH) radiation therapy, with image guided HDR prostate brachytherapy. Using iso-equivalent doses, a non-inferiority analysis will be done in order to prove UH non-inferior to MH, toxicity wise. Acceptability, tolerability, acute and late toxicity will be reported. MRI visible dominant intra-prostatic lesion will be outlines and variability between radiation oncologists and radiologists will be reported. As secondary objective, biochemical and clinical failure free survival will be reported at 5 \\& 10 years.",[62,435,436,116,117,26],"Radiotherapy Side Effect","Hypofractionation",[438,439,440],"hypo fractionation","brachytherapy","Ultra Hypo fractionation","2025-09-07",{"date":443,"type":35},"2025-09-09",{"date":445,"type":35},"2014-04",{"date":447,"type":20},"2033-12",{"name":449,"class":42},"CHU de Quebec-Universite Laval",{"id":451,"slug":452,"hasResults":11,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":456,"eligibilityCriteria":457,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":458,"targetDuration":4,"studyType":21,"phases":460,"briefSummary":461,"conditions":462,"keywords":463,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":476,"locationsCount":43},"100511230","24-gy-in-one-fraction-urethral-sparing-hdr-like-sbrt-for-prostate-cancer-100511230","NCT05936736","24 Gy in One Fraction Urethral-sparing \"HDR Like\" SBRT for Prostate Cancer","24 Gy in One Fraction Urethral-sparing \"High-Dose-Rate Like\" Stereotactic Body RadioTherapy for Prostate Cancer: a Single-center Non-randomized Prospective Clinical Study (PRO-FAST)","PRO-FAST","Inclusion Criteria:\n\n* Histological diagnosis of prostate adenocarcinoma, International Society of Urological Pathology (ISUP) grade groups 1-5\n* Patients over 18 years of age\n* Signed informed consent\n* Negative lymph nodes confirmed by imaging (PSMA PET\u002FCT and\u002For pelvic MRI with and without contrast medium) where recommended by guidelines (intermediate and high risk patients, according to National Comprehensive Cancer Network (NCCN) guidelines) in the previous 3 months\n* Clinical M0 (PSMA PET\u002FCT and\u002For bone scan and\u002For pelvic MRI with and without contrast medium in suspected patients and unfavorable intermediate and high risk patients, according to NCCN guidelines), in the previous 3 months\n* Acceptable uroflowmetry: peak urine flow index (peak flow preferably ≥ 15 ml\u002Fs), post voiding residue (PVR) ≤50 cc. If lower, acceptable if, by carrying out 3 months of neoadjuvant hormone therapy + alpha-lytic for the reduction of prostate volume, uroflowmetry is reset to at least ≥ 12 ml\u002Fs.\n* PS (ECOG) ≤2\n* No previous pelvic radiotherapy\n* Other conditions necessary for the correct execution of the proposed treatment (ability to fill in the questionnaires for the evaluation of the Quality of Life EORTC QLQ-C30, EORTC QLQ-PR25, IPSS, IIEF-5, EPIC 26)\n\nExclusion Criteria:\n\n* Serious systemic diseases\n* Psychic or other disorders that may prevent the patient from signing the informed consent\n* Previous invasive cancer, except skin cancer (excluding melanoma) unless patient free of disease for at least 3 years (e.g. carcinoma in situ of the oral cavity or bladder)\n* Lymph node disease (N1)\n* Evidence of distant metastases (M1)\n* IPSS questionnaire data \\> 20 points\n* Uroflowmetry with maximum basal flow ≤ 11 ml\u002Fsec and\u002For PVR \\>100 ml\n* Concomitant urinary\u002Fgastrointestinal inflammatory diseases (e.g. ulcerative colitis, Crohn's disease)\n* Overactive bladder\n* Impossibility of implantation of fiducials\n* Inability or refusal to place bladder catheter for simulation CT and MR\n* Inability to perform simulation MRI\n* Contraindication for hormonal treatment for patients with unfavorable intermediate, high or very high risk disease\n* Non-compliance with dose limits established in the treatment plan",{"count":459,"type":20},70,[23],"Patients with prostate cancer who are candidates for stereotactic radiotherapy to the prostate and seminal vesicles will undergo staging exams, which will include prostate specific membrane antigen (PSMA) positron emission tomography-computed tomography (PET-CT). If the PET scan is negative and the uroflowmetry is acceptable, the patients will perform the treatment, after fiducial implantation, simulation CT and magnetic resonance (MR), in a single fraction, delivered with a high-dose-rate (HDR)-like urethral sparing technique. In 70 patients, acute and late toxicity, biochemical control, overall survival, cancer specific-survival, and quality of life (through specific questionnaires) will be evaluated.",[26],[62,464,465,466,467,468],"Single fraction SBRT","Urethral sparing HDR like","PSMA PET\u002FCT","Organ movement","Radiomics","2025-06-06",{"date":471,"type":35},"2025-06-08",{"date":473,"type":35},"2023-11-08",{"date":475,"type":20},"2030-05",{"name":477,"class":42},"IRCCS San Raffaele",{"id":479,"slug":480,"hasResults":11,"nctId":481,"briefTitle":482,"officialTitle":482,"acronym":4,"eligibilityCriteria":483,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":484,"enrollmentInfo":485,"targetDuration":4,"studyType":21,"phases":487,"briefSummary":488,"conditions":489,"keywords":490,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":497,"lastUpdatePostDateStruct":498,"startDateStruct":500,"completionDateStruct":502,"leadSponsor":504,"locationsCount":43},"100534429","extraperitoneal-single-port-robotic-assisted-radical-prostatectomy-rarp-versus-transperitoneal-multi-port-rarp-in-the-treatment-of-prostate-cancer-sino-top-100534429","NCT06238713","Extraperitoneal SINgle-port rObotic-assisted Radical Prostatectomy (RARP) Versus Transperitoneal Multi-port RARP in the Treatment Of Prostate Cancer (SINO-TOP)","Inclusion Criteria:\n\n1. Men aged 18 years ≤ age ≤ 75 years;\n2. Prostate biopsy within 6 months with diagnosis of organ-localized prostate cancer with preoperative staging of T1c to T2b,N0M0;.\n3. Gleason Score\\\u003C8.\n4. PSA\\\u003C20ng\u002Fml.\n5. Pathologic diagnosis of prostate follicular adenocarcinoma or prostate ductal adenocarcinoma;\n6. The patient has healthy sexual function before surgery and intention for sexual activities after surgery;\n7. Physiological condition acceptable for laparoscopic surgery;\n8. Willing to cooperate and complete the study follow-up and related examinations;\n9. The subject or his agent voluntarily participates in this trial and signs the written informed consent;\n10. The questionnaire can be completed in Chinese.\n11. The patient has been informed of the trial;\n\nExclusion Criteria:\n\n1. High-risk and non-organ localized prostate cancer (clinical stage ≥ T2c, GS ≥ 8, PSA \\> 20ng\u002Fml);\n2. Special type of prostate cancer， such as neuroendocrine etc.;\n3. History of previous abdominal surgery and radiotherapy which may affect abdominal incision and Port placement;\n4. Recent surgery of rectum, perianal abscess or around fistula and perineal area;\n5. Patients who have undergone previous electro-prostatectomy\u002Fenucleation of the prostate;\n6. Non-recurrent patients with less than 12 months of follow-up;\n7. ECOG\\>1.\n8. Combination of other systemic tumors;\n9. had received any type of preoperative antitumor therapy;\n10. Suffering from poor general condition with the presence of one of the following conditions: including severe mental disorders, cardiovascular disease, active infections, bone marrow transplantation within 3 months, or significant abnormalities in organ function;\n11. Participation in other clinical studies or previous treatment with any gene therapy product within the last 3 months;\n12. Other conditions that the researchers believe may affect the experimental results or are unethical;","75 Years",{"count":486,"type":20},480,[23],"This study is a two-arm, multicenter, randomized controlled clinical trial on whether single-port extraperitoneal VIP RARP is non-inferior to multi-port transperitoneal RARP in terms of functional recovery rate and other key metrics.",[63,26],[62,491,492,493,494,495,496],"Robotic-assisted Radical Prostatectomy","da Vinci surgical robot","Potency","Non-inferiority","RCT","Continence","2024-08-02",{"date":499,"type":35},"2024-08-05",{"date":501,"type":35},"2024-01-08",{"date":503,"type":20},"2025-12",{"name":505,"class":42},"Shanghai Changzheng Hospital",{"id":507,"slug":508,"hasResults":11,"nctId":509,"briefTitle":510,"officialTitle":511,"acronym":512,"eligibilityCriteria":513,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":514,"targetDuration":4,"studyType":21,"phases":516,"briefSummary":517,"conditions":518,"keywords":519,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":526,"startDateStruct":528,"completionDateStruct":530,"leadSponsor":532,"locationsCount":43},"100555910","two-fraction-ultrahypofractionated-radiotherapy-with-focal-boost-for-intermediate-risk-localized-prostate-cancer-100555910","NCT06518226","Two-Fraction Ultrahypofractionated Radiotherapy With Focal Boost for Intermediate Risk, Localized Prostate Cancer","Two-Fraction Ultrahypofractionated Radiotherapy With Focal Boost for Intermediate Risk, Localized Prostate Cancer (TURBO): Phase 2, Randomized Controlled Clinical Trial","TURBO","Inclusion Criteria:\n\n* Age ≥18 years\n* Histopathological confirmation of prostate adenocarcinoma requiring radical treatment\n* European Association of Urology (EAU) intermediate risk prostate cancer, defined as Prostate Specific Antigen (PSA) level of \\\u003C 20 ng\u002Fml, Gleason score ≤ 7, cT1c-cT2b\u002FiT3a (non-bulky, \\\u003C 20mm)\n* Written informed consent\n* Ability and willingness to comply with Patient Reported Outcome Measure (PROM) questionnaires schedule throughout the study\n* Inclusion in the Multi-OutcoMe EvaluatioN of radiation Therapy Using the MR-Linac Study (MOMENTUM)\n\nExclusion Criteria:\n\n* Contraindications to MRI\n* International Prostate Symptom Score (IPSS) of 15 or higher\n* Prostate volume \\> 80 cc\n* Comorbidities which predispose to significant toxicity (e.g., inflammatory bowel disease)\n* Metal pelvic implants which cause artefact on MR-imaging sequences\n* Previous radical prostatectomy\n* Previous pelvic radiotherapy\n* Previous invasive malignancy within the last 5 years, excluding basal cell carcinoma of the skin",{"count":515,"type":20},160,[23],"The goal of this clinical trial is to assess the non-inferiority irradiating low and intermediate risk, localized prostate cancer in two fractions of radiotherapy, compared to five fractions of radiotherapy which is the standard of care. The main question it aims to answer are:\n\n\\- Do participants in the interventional arm have more physician-reported grade 2 or higher acute Common Terminology Criteria for Adverse Events (CTCAE) genitourinary (GU) side effects?\n\nParticipants in the intervention arm will receive two fractions of radiotherapy, in which the prostate is irradiated with 12 Gy per fraction and the tumor receives a boost of up to 13.5 Gray (Gy), over the course of 8 days. Those in the control arm will receive five fractions of radiotherapy of 7.25 Gy each to the prostate, without a boost to the tumor, over the course of 16-18 days.",[62,63,26],[520,521,522,523,524],"MR-guided adaptive radiotherapy","MRgRT","Quality of life","Patient-reported outcomes","Ultrahypofractionation","2024-07-18",{"date":527,"type":35},"2024-07-24",{"date":529,"type":35},"2024-03-28",{"date":531,"type":20},"2031-02-01",{"name":533,"class":42},"UMC Utrecht"]