[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prostate-ca\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prostate-ca":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,46,75,105,139,166,189,208,234,257,283,307,325],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"100642128","prostate-mri-analysis-by-radiologists-and-artificial-intelligence---disease-identification-and-guided-management-100642128",false,"NCT07647445","Prostate MRI Analysis by Radiologists and Artificial Intelligence - Disease Identification and Guided Management","A Study Assessing Whether Artificial Intelligence is Non-inferior to Radiologists in the Diagnosis of Clinically Significant Prostate Cancer.","PARADIGM","Inclusion Criteria:\n\n1. Men at least 18 years of age referred with clinical suspicion of prostate cancer\n2. Serum PSA ≤ 20 ng\u002FmL\n3. Fit to undergo all procedures listed in the protocol\n4. Able to provide written informed consent\n\nExclusion Criteria:\n\n1. Prior prostate biopsy\n2. Prior prostate MRI on a previous encounter\\*\n3. Prior treatment for prostate cancer\n4. Contraindication to MRI (e.g. claustrophobia, pacemaker)\n5. Metalwork that would give rise to artefact on MRI (e.g. hip prosthesis, pelvic\u002Fspinal metalwork)\n6. Contraindication to prostate biopsy\n7. Unfit to undergo any procedures listed in protocol\n\n   * An MRI on a previous encounter means a previous prostate MRI which has been seen by a doctor and has been used to inform patient management at the time of the original MRI.","MALE","18 Years",{"count":20,"type":21},500,"ESTIMATED","INTERVENTIONAL",[24],"NA","Prostate cancer is the most common male cancer in 112 countries and makes up 7% of global cancer cases, and is the second leading cause of cancer-related deaths in men.\n\nNormally, men with suspected prostate cancer undergo a prostate MRI, and then a Radiologist would review this scan to identify any suspicious areas for cancer within the prostate. Prostate MRI interpretation, however, is an expert skill with a steep learning curve, and internationally, there is a growing shortage of Radiologists.\n\nThe PARADIGM trial aims to assess if AI can perform just as well as Radiologists in interpreting prostate MRI scans to identify prostate cancer. Enrolled participants will undergo a prostate MRI, which is the normal method used for investigating suspected prostate cancer. AI and a Radiologist will both interpret the MRI, without knowledge of each other's interpretation. Once both reports have been made, the Radiologist will be asked to produce a third, combined report.\n\nIf there is a suspicious area in the prostate identified either by AI or the Radiologist, targeted biopsies will be performed. If there are no suspicious areas on the MRI and if you are at low risk of harbouring cancer, which occurs in about 30% of men, then no biopsy will be taken at all.",[27],"Prostate CA",[29,30,31,32,33],"MRI","Prostate","Cancer","AI","Artificial Intelligence","NOT_YET_RECRUITING","2026-06-29",{"date":37,"type":38},"2026-06-30","ACTUAL",{"date":40,"type":21},"2026-10",{"date":42,"type":21},"2029-01",{"name":44,"class":45},"University College, London","OTHER",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100580317","phase-2-phase-ii-randomized-trial-of-2-versus-5-fraction-prostate-stereotactic-ablative-radiotherapy-for-intermediate-risk-prostate-cancer-100580317","NCT06835725","Phase II Randomized Trial of 2 Versus 5 Fraction Prostate Stereotactic Ablative Radiotherapy for Intermediate Risk Prostate Cancer","PHASE II RANDOMIZED TRIAL OF 2- VS 5-FRACTION PROSTATE STEREOTACTIC ABLATIVE RADIOTHERAPY","ADAPT-25","Inclusion Criteria:\n\n* • Age 18 or older.\n\n  * Able to provide informed consent.\n  * ECOG performance status 0 - 2.\n  * Fit for all protocol treatment and follow-up.\n  * Life Expectancy \\> 5 years.\n  * Histologically confirmed adenocarcinoma of the prostate, NCCN low or intermediate risk, with biopsy performed within the last 18 months:\n\nLow risk = cT1-T2a,Gleason ≤ 6, and PSA \\\u003C 10ng\u002FmL. Intermediate risk = at least one of: cT2b\u002FT2c, PSA 10-20ng\u002FmL, or Gleason 7, but not high risk.\n\n* 6 months of Androgen Deprivation Therapy (ADT) is permitted for those with NCCN unfavorable intermediate risk disease (aka high-tier intermediate risk disease), defined as intermediate risk disease with one or more of: two or three intermediate risk features, Gleason 4+3, or ≥50% biopsy cores positive.\n* For those with NCCN unfavorable intermediate risk disease, it is permitted for ADT to have been initiated prior to study enrollment provided it is possible for radiotherapy to be completed before completion of 6 months of ADT.\n* Prostate volume \\\u003C100cc based on imaging or digital rectal examination.\n* PSA within 90 days prior to registration. If ADT is started before registration, then the PSA must have been done no more than 90 day prior to the date of the first ADT injection.\n* CT abdomen and pelvis within the 6 months prior to registration (may be omitted for NCCN low risk participants). If particpant started on ADT prior to registration, CT should be done before first ADT injection.\n* Bone scan within the 6 months prior to of registration (may be omitted for NCCN low risk participants). If particpant started on ADT prior to registration, bone scan should be done before first ADT injection.\n* Must be appropriate for and willing to undergo implantation of prostate fiducial markers and Space OAR Hydrogel.\n\nExclusion Criteria:\n\nClinical stage cT3 or greater. Gleason score 8 or greater. PSA \\> 20ng\u002FmL or greater. NCCN high or very high risk. Pelvic nodal metastases. Distant metastases. Previous malignancy within the last 5 years except basal or squamous cell carcinomas of the skin.\n\nPrevious pelvic radiotherapy. Any prior active local treatment for prostate cancer. Participants previously on active surveillance are eligible if they continue to meet all other eligibility criteria.\n\nUnilateral or Bilateral hip prostheses. Medical conditions likely to make radiotherapy inadvisable (e.g., inflammatory bowel disease).\n\nMedical condition that would make implantation of fiducial markers or hydrogel rectal spacer unsafe, in the opinion of the treating physician (e.g., pelvic or prostate abscess).\n\nMedical condition or implant that prohibits MRI (e.g. pacemaker) Trans-urethral resection of the prostate (TURP), GreenLight Laser or Holmium Laser Prostate procedure within 6 months of radiotherapy.",{"count":55,"type":21},100,[57],"PHASE2","Prostate cancer is a common cancer, and a significant cause of cancer death in men. There are many potentially curative treatment options for prostate cancers that have not spread. A relatively recent option is called prostate stereotactic ablative radiotherapy (SABR). SABR is a form of external beam radiotherapy, where patients receive a small number (5-7) of treatments (also called fractions) of radiation delivered in a highly accurate and precise fashion. Standard prostate SABR is generally given in 5 fractions and has been shown to be at least as effective as conventional external beam radiotherapy. Disease control with SABR appears excellent, and it compares favorably to surgery in terms of side effects and quality of life.\n\nIn theory, reducing the number of fractions from 5 to 2 may improve disease control and reduce side effects, in addition to providing added convenience for patients. Small studies suggest prostate SABR in 2 fractions may be highly effective and well tolerated. However, there is little available data comparing 2 and 5 fraction SABR head to head to tell us which is superior.\n\nTwo fraction SABR involves delivery of 2 large dose fractions of radiotherapy which could result in significant side effects if proper precautions are not taken. The use of continuous tracking of the prostate gland position during treatment delivery reduces the risk of missing the prostate or overdosing organs near by. Such tracking has been shown to reduce bladder side effects. Also, the use of a rectal spacer placed between the prostate and rectum has been shown to reduce bowel side effects. Also, advanced artificial intelligence (AI)-directed computer applications could potentially improve the targeting of radiation during each treatment.\n\nThe ADAPT-2 study is a randomized phase II trial comparing standard 5-fraction SABR with an experimental 2-fraction approach in men with intermediate risk prostate cancer. All treatment, whether 5 or 2-fractions, will use continuous prostate tracking (also called triggered imaging) and a rectal spacer (called Space OAR Hydrogel) to minimize side effects. The trial will also evaluate the potential of a new AI-guided dose guidance application to see if it can improve current methods of targeting SABR each day. This aspect of the study will be offline; that is, the AI application will not be used to actually target treatment for the trial patients. Rather, daily targeting of SABR will use standard conventional means, and the AI application will be studied in a simulated fashion to determine it is useful and can be incorporated into workflow.\n\nThe main goal of the ADAPT-25 study is to compare the long-term side effects and quality of life between 5- and 2-fraction prostate SABR. Secondary goals will be to compare the long-term disease control between 5-and 2-fraction prostate SABR, and to evaluate whether a novel AI-directed dose guidance application can be used to better target SABR by reducing doses to neighboring organs, and whether it can be easily fit into prostate SABR workflow.",[27],[61,62,63],"stereotactic radiotherapy","SBRT","SABR","RECRUITING","2026-06-22",{"date":67,"type":38},"2026-06-24",{"date":69,"type":38},"2025-09-04",{"date":71,"type":21},"2033-04-30",{"name":73,"class":45},"British Columbia Cancer Agency",2,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":88,"conditions":89,"keywords":90,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":104},"100591947","trans-and-non-binary-prostate-specific-antigen-reference-interval-determination-study-100591947","NCT06987045","Trans and Non-binary Prostate-Specific Antigen Reference Interval Determination Study","TransPRIDE","Inclusion Criteria:\n\n* • Aged \\>40\n\n  * Transgender or non-binary (identify with a gender other than the one assigned at birth)\n  * With a prostate\n  * Fulfills at least one of the following 3 criteria with regards to gender-affirming medical care:\n\n    * Taking oestradiol for at least the last 3 months\n    * Taking anti-androgens for at least the last 3 months\n    * Ever had bilateral orchidectomy\n  * Eligible for National Health Service (NHS) treatment\n\nExclusion Criteria:\n\n* • History of prostate cancer (Prostate cancer) at any time\n\n  * History of prostate surgery at any time\n  * History of prostate radiotherapy at any time\n  * History of benign prostatic hypertrophy (enlarged prostate) at any time\n  * Vaginoplasty within 12 months\n  * Orchidectomy or vulvoplasty within three months\n  * Sexually Transmitted Infection (STI) within 6 weeks of blood sample\n  * Active urinary infection or within 6 weeks of blood sample\n  * Prostatitis within 6 weeks of blood sample\n  * Urological intervention (e.g. prostate biopsy) within 6 weeks of blood sample\n  * Unwilling to give consent\n  * Lacking capacity to give consent\n  * In the secure estate",true,"ALL","40 Years","100 Years",{"count":20,"type":21},"OBSERVATIONAL","The prostate specific antigen (PSA) blood test can help diagnose prostate problems, including cancer.\n\nThe prostate is an organ in the pelvis. It is found in cisgender men, transgender (trans) women and some non-binary people.\n\nAnyone with a prostate can get prostate cancer. The prostate remains after genital (lower) surgery. The hormones and surgeries that trans women and non-binary people might have can lower the PSA. We do not have good data on the normal PSA levels are for this group\n\nTransPRIDE is a research study that will help us find the normal levels of PSA in trans women and non-binary people with prostates.\n\nResearchers will ask 500 trans women and non-binary people with prostates to take part. They will need to be aged 40 or over. They will need to be on hormones or have had lower surgery. They will be called after 6 months to recheck their health. If a person has a high PSA, they may be sent for more tests.\n\nKnowing the normal PSA level for trans women and non-binary people will help doctors to find and treat their prostate cancer more quickly.",[27],[91,92,93,94],"Prostate Cancer","Transwomen","Non-binary","prostate","2026-06-03",{"date":97,"type":38},"2026-06-04",{"date":99,"type":38},"2026-04-04",{"date":101,"type":21},"2028-03-31",{"name":103,"class":45},"Queen Mary University of London",1,{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":22,"phases":114,"briefSummary":116,"conditions":117,"keywords":120,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":104},"100564618","phase-1-neoadjuvant-darolutamide-and-relugolix-combination-preceding-radical-prostatectomy-for-prostate-cancer-100564618","NCT06631521","Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer","Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for High Risk Localized and Locally Advanced Prostate Cancer: A Phase I\u002FIb Trial","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed adenocarcinoma of the prostate\n2. ECOG performance status 0-1\n3. Ability to swallow oral medications and comply with study procedures and requirements.\n4. Males ≥18 years\n5. Participants must have adequate organ and marrow function as below:\n\n   1. Absolute neutrophil count (ANC) ≥1,500\u002Fmm3 or ≥1.5 x 109\u002FL;\n   2. Platelets ≥100,000\u002Fmm3 or ≥100 x 109\u002FL;\n   3. Hemoglobin ≥8 g\u002FdL (may have been transfused).\n   4. Estimated creatinine clearance ≥30 mL\u002Fmin as calculated using the Cockcroft-Gault equation.\n   5. Total serum bilirubin \\<1.5 x upper limit of normal (ULN), less than 2.0 x ULN if suspected Gilbert's syndrome;\n   6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 2.5 x ULN.\n6. Must be a candidate for RP\n7. Clinical stage cT2-4, N0-1\n8. Mandatory to identify tumor availability (≥10 FFPE slides, 5 µM thickness \\& 1 stained H\\&E slide OR tumor block)\n9. High-risk PCa defined as one of the following-\n\n   * Gleason score (GS) ≥ 4 + 3 with ≥ 6 positive systematic biopsies (SB)\n   * GS ≥ 4 + 3 with ≥ 3 SB and prostate-specific antigen (PSA) ≥ 20 ng\u002FmL\n   * GS ≥ 9 in ≥ 1 SB or targeted biopsies (TB) -≥ 2 SB or TB with continuous GS ≥ 8, each with ≥ 80% involvement.\n\nExclusion Criteria:\n\n1. Histologic variants including neuroendocrine differentiation, small cell, sarcomatoid, ductal adenocarcinoma, squamous or transitional cell carcinoma) comprising more than 50% of the sample as determined by pathology review\n2. Participants who have had chemotherapy or radiotherapy within 4 weeks prior to planned cycle 1 day 1 of study treatment.\n3. Participants who have received anti-neoplastic intervention or experimental antineoplastic therapy within 14 days of planned cycle 1 day 1 of study therapy.\n4. Participants who are receiving any other investigational agents.\n5. Participants who have previously received darolutamide, relugolix, LHRH agonist\u002Fantagonist or another novel androgen blocking therapy (abiraterone, apalutamide, enzalutamide) within 1 year are excluded (prior bicalutamide that was discontinued ≥14 days prior to planned cycle 1 day 1 is allowed).\n6. Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e. have residual toxicities ≥Grade 2) with the exception of alopecia.\n7. Any of the following within 6 months before planned cycle 1 day 1 of study therapy:\n\n   * Stroke\n   * Myocardial infarction\n   * Severe\u002Funstable angina pectoris\n   * Coronary\u002Fperipheral artery bypass graft\n   * Congestive heart failure New York Heart Association (NYHA) Class III or IV.\n8. Known or suspected contraindications, hypersensitivity or allergy to darolutamide or relugolix or to any of their excipients.\n9. Participants with hepatitis C, hepatitis B or human immunodeficiency (HIV) who are on anti-viral therapy that has the potential to interact with darolutamide or relugolix.\n10. Participants treated with drugs known to be strong inhibitors and\u002For inducers of cytochrome P450 3A4 (CYP3A4) and the treatment cannot be discontinued or switched to a different medication at least 5 half-lives prior to starting study drug.\n11. NOTE: precaution is warranted with concomitant use of agents with a narrow therapeutic index that are substrates of P-gp, BCRP and OCT1.\n12. The participant has serious and\u002For uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment \\[e.g. estimated creatinine clearance less than 30ml\u002Fmin\\], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).\n13. Concurrent active malignancy whose natural history or treatment has the potential to interfere with safety or efficacy assessment of the investigational regimen. Patients with non-melanomatous skin cancer, superficial bladder cancer, cancer not needing active therapy for at least 2 years, cancer for which the treating investigator deems the subject to be in remission, or any prior malignancy that was treated with curative intent (no evidence of disease for at least 3 years) are permitted to enroll.",{"count":113,"type":21},30,[115],"PHASE1","The goal of this clinical trial is to determine the safety and feasibility of a new combination of darolutamide and relugolix as neoadjuvant therapy preceding radical prostatectomy (RP) for high-risk prostate cancer (PCa) in adult males.",[27,118,119],"Prostate Cancer (Adenocarcinoma)","Prostate Cancer Surgery",[91,121,122,123,124,125,126,127,128,129],"High-Risk Prostate Cancer","Neoadjuvant Therapy","Radical Prostatectomy","Darolutamide","Relugolix","Androgen Receptor Antagonists","Gonadotropin-Releasing Hormone Antagonists","Clinical Trial Phase I\u002FIb","PSA Response","2026-02-03",{"date":132,"type":38},"2026-02-05",{"date":134,"type":38},"2024-10-22",{"date":136,"type":21},"2026-06",{"name":138,"class":45},"AdventHealth",{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":22,"phases":149,"briefSummary":150,"conditions":151,"keywords":153,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":104},"100590857","phase-2-fezolinetant-for-treating-hot-flashes-in-men-with-prostate-cancer-100590857","NCT06972875","Fezolinetant for Treating Hot Flashes in Men With Prostate Cancer","Efficacy and Safety of Fezolinetant for Treatment of Moderate to Severe Vasomotor Symptoms Associated With Androgen-Deprivation Therapy in Men With Prostate Cancer (FLASH): A Phase 2 Study","FLASH","Inclusion Criteria:\n\nAge ≥ 18 years Men who are currently receiving Androgen Deprivation Therapy (ADT) for the treatment of prostate cancer. ADT is defined by a history of orchiectomy, or ongoing usage of gonadotropin-releasing hormone agonists or antagonists (e.g. leuprolide, degarelix, relugolix). Men receiving Androgen Receptor Pathway Inhibitors (ARPI) such as abiraterone, enzalutamide, apalutamide, and darolutamide are eligible.\n\nPatients must be on a stable dose of all hormonal therapies for at least 28 days prior to registration and must not be planning to discontinue this therapy for at least 42 days following registration. Additional ARPI agents (e.g. abiraterone or enzalutamide) are allowed to be added during the Extension Phase of the trial, but not during the Treatment Phase.\n\nPatients receiving radiation therapy during the study period are eligible. An eligible patient must have bothersome hot flashes for ≥ 7 days prior to consent, resulting in an average of four or more hot flashes per day of sufficient severity to cause the patient to seek therapeutic intervention.\n\nLife Expectancy of 6 months or greater. Language: In order to complete the mandatory participant-completed measures, participants must be able to speak and read English.\n\nExclusion Criteria:\n\nCurrent or future planned use of any of the following agents during the study period: drugs that are not FDA approved for use in humans, any drug with category X interactions with fezolinetant; androgens, estrogens, progesterone analogs, or complementary\u002Falternative medicine taken for the purpose of managing hot flashes. Prior use of these agents is permitted as long as they are discontinued before registration. Stable dosing (≥ 1 month) of gabapentin, cholinergic agonists, cholinesterase inhibitors for other indications is permitted.\n\nHistory of cirrhosis Elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2 X ULN or total bilirubin \\> ULN eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m2 based on reported MDRD estimate. Current use of CYP1A2 inhibitors (fezolinetant is a substrate of CYP1A2).",{"count":148,"type":21},32,[57],"This study is for men with prostate cancer who are experiencing hot flashes due to treatments that lower testosterone. Hot flashes can affect your quality of life and make it harder for patients to continue their treatment, so researchers want to find a better way to manage them. The study is testing a drug called fezolinetant, which might help reduce hot flashes without using hormones. Fezolinetant is a drug that is currently approved for the treatment of hot flashes in menopausal women.",[27,152],"Androgen Deprivation Therapy",[154,155,156,157],"prostate cancer","androgen deprivation therapy","hot flash","fezolinetant","2026-02-02",{"date":132,"type":38},{"date":161,"type":38},"2025-12-18",{"date":163,"type":21},"2027-02",{"name":165,"class":45},"University of Vermont",{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":173,"enrollmentInfo":174,"targetDuration":4,"studyType":22,"phases":176,"briefSummary":178,"conditions":179,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":104},"100582275","phase-2-clinical-study-of-fasudil-hydrochloride-and-pd1-inhibitor-combined-with-androgen-deprivation-in-neoadjuvant-therapy-of-prostate-cancer-100582275","NCT06861192","Clinical Study of Fasudil Hydrochloride and PD1 Inhibitor Combined With Androgen Deprivation in Neoadjuvant Therapy of Prostate Cancer","A Randomized Controlled Study of Fasudil Hydrochloride and PD1 Inhibitor Combined With Androgen Deprivation in Neoadjuvant Therapy for Prostate Cancer","Inclusion Criteria:\n\n* ① Age ≥18 years and ≤85 years;\n\n  * Histologically confirmed prostate cancer without small cell features;\n\n    * Metastatic prostate cancer was identified by imaging examination with ≤5 oligometastases (bone or lymph node metastases) or cT3-4 stages; ④The score of ECOG (Eastern Cooperative Oncology Group) was 0-1; ⑤ All patients voluntarily sign informed consent, and can adhere to treatment and follow-up;\n\nExclusion Criteria:\n\n* ①Any previous or ongoing PCa treatment, including radiotherapy, chemotherapy, ADT, etc.\n\n  * Previous prostatectomy;\n\n    * Any other serious basic medical, mental, psychological, and other diseases that, in the judgment of the investigator, may affect the treatment of the patient\n\n      * Allergic to the drugs used; ⑤ Refuse to undergo radical prostatectomy; ⑥ According to the investigator's judgment, it is not suitable to participate in this clinical trial;","85 Years",{"count":175,"type":21},83,[57,177],"PHASE3","The high incidence of prostate cancer is one of the important diseases that threaten the health of old men in our country. Although androgen deprivation therapy is an important treatment option for prostate cancer, although neoadjuvant androgen deprivation therapy combined with radical prostatectomy reduced the positive rate of surgical margins, it did not show statistically significant improvement in prostate-specific antigen (PSA). At the same time, few trials reported pathological complete response (pCR) and minimal residual lesion (MRD).\n\nThe purpose of this project is to verify the therapeutic effect of fasudil hydrochloride and PD1 inhibitor combined with androgen deprivation in patients with locally advanced prostate cancer or oligometastatic prostate cancer before radical prostatectomy through randomized controlled clinical trials, so as to find an effective treatment for locally advanced prostate cancer or oligometastatic prostate cancer.",[27],"2025-11-17",{"date":182,"type":38},"2025-11-18",{"date":184,"type":38},"2025-02-16",{"date":186,"type":21},"2027-03-16",{"name":188,"class":45},"baotai Liang",{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":173,"enrollmentInfo":195,"targetDuration":4,"studyType":22,"phases":197,"briefSummary":198,"conditions":199,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":74},"100580209","phase-2-clinical-study-on-neoadjuvant-therapy-of-homoharringtonine-combined-with-androgen-deprivation-for-prostate-cancer-100580209","NCT06834321","Clinical Study on Neoadjuvant Therapy of Homoharringtonine Combined With Androgen Deprivation for Prostate Cancer","A Randomized Controlled Study of Homoharringtonine Combined With Androgen Deprivation in Neoadjuvant Therapy for Prostate Cancer",{"count":196,"type":21},96,[57],"The high incidence of prostate cancer is one of the important diseases that threaten the health of old men in our country. Although androgen deprivation therapy is an important treatment option for prostate cancer, although neoadjuvant androgen deprivation therapy combined with radical prostatectomy reduced the positive rate of surgical margins, it did not show statistically significant improvement in prostate-specific antigen (PSA). At the same time, few trials reported pathological complete response (pCR) and minimal residual lesion (MRD).\n\nThe purpose of this project is to verify the therapeutic effect of homoharringtonine combined androgen deprivation in patients with locally advanced prostate cancer or oligometastatic prostate cancer before radical prostatectomy through a randomized controlled clinical trial, so as to find an effective treatment for locally advanced prostate cancer or oligometastatic prostate cancer.",[27],"2025-08-31",{"date":202,"type":38},"2025-09-08",{"date":204,"type":38},"2025-03-19",{"date":206,"type":21},"2027-09-28",{"name":188,"class":45},{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":4,"eligibilityCriteria":214,"healthyVolunteers":82,"sex":83,"minAge":4,"maxAge":4,"enrollmentInfo":215,"targetDuration":217,"studyType":87,"phases":4,"briefSummary":218,"conditions":219,"keywords":220,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":104},"100563120","prostate-cancer-care-disparity-analysis-project-progap-100563120","NCT06612034","Prostate Cancer Care Disparity Analysis Project (ProGAP)","Evaluating the Worldwide Landscape of Prostate Cancer Management","Inclusion Criteria:\n\nUrologists, Uro-oncologists, Medical oncologists, Radiation oncologists\n\nExclusion Criteria:\n\nNon-clinical healthcare professionals Healthcare professionals not directly involved in the care of prostate cancer patients, Healthcare professionals with missing or incorrect email addresses",{"count":216,"type":21},400,"1 Day","This international cross-sectional study seeks to evaluate global disparities in prostate cancer management by conducting a thorough comparison of key elements across countries categorized as low-income, lower-middle-income, upper-middle-income, and high-income.\n\nThe primary question it addresses is: Are the standards of care for prostate cancer uniformly applied across different geographic regions worldwide? To achieve this, we will recruit physicians specializing in the diagnosis and treatment of prostate cancer from a diverse array of countries within these income classifications. Participants will complete a 17-question online survey.",[27],[154,221,222,223,224],"Human Development Index","survey","access to medicine","multidisciplinary care","2025-07-22",{"date":227,"type":38},"2025-07-24",{"date":229,"type":38},"2025-03-10",{"date":231,"type":21},"2025-10-30",{"name":233,"class":45},"Ankara University",{"id":235,"slug":236,"hasResults":11,"nctId":237,"briefTitle":238,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":240,"enrollmentInfo":241,"targetDuration":4,"studyType":22,"phases":243,"briefSummary":244,"conditions":245,"keywords":246,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":104},"100597307","phase-1-research-on-the-application-of-68ga-psma-cyc-pet-imaging-in-the-diagnosis-staging-and-restaging-of-prostate-cancer-100597307","NCT07056790","Research on the Application of 68Ga-PSMA-CYC PET Imaging in the Diagnosis, Staging, and Restaging of Prostate Cancer","Inclusion Criteria:\n\n* confirmed treated or untreated prostate cancer patients;\n* signed written consent.\n\nExclusion Criteria:\n\n* known allergy against PSMA;\n* any medical condition that in the opinion of the investigator may significantly interfere with study compliance.","80 Years",{"count":242,"type":21},40,[115,57],"68Ga-PSMA-CYC is a novel radiotracer targeting PSMA. In this study, we investigated the safety, biodistribution, radiation dosimetry of 68Ga-PSMA-CYC PET\u002FCT in patients with prostate cancer, and performed a head-to-head comparison with 68Ga-PSMA-617 and 68Ga-PSMA-11 to evaluate its diagnostic performance.",[27],[247,154],"psma","2025-06-30",{"date":250,"type":38},"2025-07-09",{"date":252,"type":38},"2025-05-15",{"date":254,"type":21},"2027-05",{"name":256,"class":45},"First Affiliated Hospital of Fujian Medical University",{"id":258,"slug":259,"hasResults":11,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":82,"sex":83,"minAge":18,"maxAge":264,"enrollmentInfo":265,"targetDuration":4,"studyType":22,"phases":267,"briefSummary":268,"conditions":269,"keywords":271,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":104},"100585588","phase-2-ultralow-dose-pet-imaging-for-psma-expression-100585588","NCT06904313","Ultralow Dose PET Imaging for PSMA Expression","Evaluation of Ultralow Dose PET Imaging for Detecting PSMA Expression","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Ability to provide informed consent and comply with study procedures.\n3. For female participants:\n\n   * Must not be pregnant or breastfeeding.\n   * Negative pregnancy test required for women of childbearing potential.\n\nExclusion Criteria:\n\n1. Participants who have exceeded NRC regulation for annual radiation exposure from prior research-related scans, including this study (50 mSv total).\n2. More than four prior enrollments in this study.\n3. Participants with severe claustrophobia, chronic pain, or musculoskeletal conditions that prevent completion of the PET scan\n4. Medication \\& Prior Treatment Exclusions\n\n   • Concurrent PSMA-targeted therapy (e.g., lutetium-177).\n5. Pregnant or breastfeeding individuals (negative pregnancy test required)\n6. Inability to provide informed consent\n7. Any condition that, in the investigator's judgment, may compromise participant safety or study integrity.","120 Years",{"count":266,"type":21},200,[57],"The goal of this clinical trial is to evaluate an investigational ultralow dose PET imaging technique for prostate cancer detection and monitoring. The main question it aims to answer is:\n\nCan the investigators optimize the timing, scan duration, and image reconstruction to reduce the radiation dose 10-100 fold of the current clinical standard?\n\nParticipants will be injected with a radioactive tracer called 18F-DCFPyL and be imaged on a new type of high sensitivity PET scanner for up to 3 hours",[270,27],"Healthy Volunteer",[272,154,247,273],"PET scan","nuclear imaging","2025-06-01",{"date":276,"type":38},"2025-06-04",{"date":278,"type":38},"2025-05-12",{"date":280,"type":21},"2030-06-30",{"name":282,"class":45},"Akiva Mintz",{"id":284,"slug":285,"hasResults":11,"nctId":286,"briefTitle":287,"officialTitle":287,"acronym":4,"eligibilityCriteria":288,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":289,"enrollmentInfo":290,"targetDuration":4,"studyType":22,"phases":291,"briefSummary":292,"conditions":293,"keywords":295,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":104},"100475376","evaluation-of-the-performance-of-a-novel-prostate-biopsy-system-compared-with-standard-of-care-biopsy-needle-on-quantitative-and-qualitative-tissue-parameters-100475376","NCT05470127","Evaluation of the Performance of a Novel Prostate Biopsy System Compared With Standard of Care Biopsy Needle on Quantitative and Qualitative Tissue Parameters","Inclusion Criteria:\n\n* Adult male scheduled for prostate biopsy\n* Able to provide informed consent\n* Able and willing to provide verbal assessment of his condition 5 days post-procedure\n\nExclusion Criteria:\n\n* Unwilling to provide consent","90 Years",{"count":266,"type":21},[24],"Currently used biopsy devices do not predictably obtain full cores of tissue and the tissue obtained is often fragmented and disrupted making it difficult for pathological review. This post-market study will assess the utility of the SUREcore biopsy needle and the coreCARE specimen retrieval device versus a standard of care biopsy needle and the typical tissue container used in urology offices and clinics today.",[294,27],"Prostate Disease",[27,296],"Needle biopsy","2025-05-02",{"date":299,"type":38},"2025-05-07",{"date":301,"type":38},"2022-08-01",{"date":303,"type":21},"2025-12",{"name":305,"class":306},"Uro-1 Medical","INDUSTRY",{"id":308,"slug":309,"hasResults":11,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":173,"enrollmentInfo":313,"targetDuration":4,"studyType":22,"phases":315,"briefSummary":316,"conditions":317,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":321,"completionDateStruct":322,"leadSponsor":324,"locationsCount":4},"100582273","phase-2-clinical-study-of-geranium-wilfordii-combined-with-androgen-deprivation-in-neoadjuvant-therapy-of-prostate-cancer-100582273","NCT06861166","Clinical Study of Geranium Wilfordii Combined With Androgen Deprivation in Neoadjuvant Therapy of Prostate Cancer","Randomized Controlled Study of Geranium Wilfordii Combined With Androgen Deprivation in Neoadjuvant Therapy for Prostate Cancer",{"count":314,"type":21},95,[57,177],"The high incidence of prostate cancer is one of the important diseases that threaten the health of old men in our country. Although androgen deprivation therapy is an important treatment option for prostate cancer, although neoadjuvant androgen deprivation therapy combined with radical prostatectomy reduced the positive rate of surgical margins, it did not show statistically significant improvement in prostate-specific antigen (PSA). At the same time, few trials reported pathological complete response (pCR) and minimal residual lesion (MRD).\n\nThe purpose of this project is to verify the efficacy of geranium combined with androgen deprivation in the treatment of locally advanced prostate cancer or oligometastatic prostate cancer before radical prostatectomy through randomized controlled clinical trials, so as to find an effective treatment for locally advanced prostate cancer or oligometastatic prostate cancer.",[27],"2025-03-05",{"date":320,"type":38},"2025-03-06",{"date":229,"type":21},{"date":323,"type":21},"2027-03-10",{"name":188,"class":45},{"id":326,"slug":327,"hasResults":11,"nctId":328,"briefTitle":329,"officialTitle":330,"acronym":4,"eligibilityCriteria":331,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":332,"targetDuration":4,"studyType":22,"phases":333,"briefSummary":334,"conditions":335,"keywords":340,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":351,"locationsCount":353},"100565015","phase-2-fk-pc101-as-adjuvant-therapy-for-men-with-high-risk-prostate-cancer-100565015","NCT06636682","FK-PC101 as Adjuvant Therapy for Men With High-Risk Prostate Cancer","A Multicenter, Adaptive, Phase 2, Randomized, Open-label Study of Irradiated Autologous Cellular Vaccine in Men With High-Risk Prostate Cancer Following Prostatectomy","Inclusion Criteria:\n\n* Has localized high-risk or very high-risk prostate cancer based on the NCCN v4.2023 classification.\n* Has ≥3 prostate biopsy cores with ≥50% tumor involvement.\n* Has PSA \\>4 ng\u002FmL ≤28 days prior to enrollment.\n* Has no evidence of distant metastases based on PSMA-PET\u002FCT performed ≤28 days prior to enrollment.\n* Is a candidate for radical prostatectomy, and scheduled radical prostatectomy date must be 3 to 14 days after enrollment.\n* Has not received nor plans to receive neoadjuvant (preoperative) radiation therapy, androgen deprivation therapy (ADT), or any other anticancer therapy.\n* Has a life expectancy \\>5 years.\n\nAdditional key eligibility criteria immediately postoperative for inclusion in the randomized population include:\n\n* Stage \\>pT3a (tumor has extended outside of the prostate on one side).\n* Gleason score of 8, 9, or 10 (high\u002Fvery high) on prostatectomy specimen.\n* Subjects with pT3b or pT4 tumors with a Gleason sum 7 (4+3) are eligible.\n* Pelvic lymph node dissection (PLND) is required with either pN0 or pN1 nodal staging permitted.\n* Subjects must have negative surgical margins or microscopic-only positive surgical margins.\n\nFinal eligibility criteria at 2 months postoperative for randomization include:\n\n* FK-PC101 has been produced for the subject and meets all release specifications.\n* An undetectable PSA (\\\u003C0.04 ng\u002FmL) on the most recent test performed prior to randomization (Day -4 to -7).\n* No prior, current, or planned future postoperative or adjuvant XRT, hormonal therapy such as ADT, or any other anticancer therapy (future therapy should not be administered until evidence exists of prostate cancer disease recurrence \\[such as PSA recurrence\\]).\n* Adequate organ function based on CBC and chemistry studies within 2 weeks of Day 1 (Day -14 to -7). Specific laboratory requirements include:\n\n  * Absolute neutrophil count (ANC) \\>1000\u002FµL\n  * Platelet count \\>100,000\u002FµL.\n  * Hemoglobin \\>8.0 gm\u002FdL.\n  * Estimated glomerular filtration rate (eGFR) \\>60 mL\u002Fminute based on Cockcroft-Gault formula.\n  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both \\\u003C2 × upper limit of normal (ULN).\n  * Albumin \\>3.0 gm\u002FdL.\n* Capable of giving signed informed consent, which includes compliance with the requirements and restrictions of the study.\n\nExclusion Criteria:\n\n* Has an additional active malignancy that may confound the assessment of the study endpoints. If the subject has a past cancer history (active malignancy within 2 years prior to study entry) with substantial potential for recurrence, this must be discussed with the Sponsor before study entry. Note: Subjects with the following concomitant neoplastic diagnoses are eligible: non-melanoma skin cancer and carcinomas in situ (including breast DCIS, transitional cell carcinoma\u002FNMIBC, anal carcinoma, and melanoma in situ).\n* Is eligible for and elects to receive adjuvant therapy following RP.\n* Has clinically significant cardiovascular disease (e.g., uncontrolled or any New York Heart Association \\[NYHA\\] Class 3 or 4 congestive heart failure, uncontrolled angina, history of myocardial infarction, unstable angina, pulmonary embolism or stroke within 6 months prior to study entry, uncontrolled hypertension, or clinically significant arrhythmias not controlled by medication).\n* Has uncontrolled, clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease, pulmonary hypertension) that in the opinion of the Investigator would put the subject at significant risk for pulmonary complications during the study.\n* Has known metastases, such as bone, visceral, or brain or leptomeningeal metastases.\n* Has an active autoimmune disease or Grade ≥3 pneumonitis that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) or treatment with drugs (e.g., neomercazol, carbamazole) that function to decrease the generation of thyroid hormone by a hyperfunctioning thyroid gland (e.g., in Graves' disease) is not considered a form of systemic treatment of an autoimmune disease.\n* Is currently receiving systemic steroid therapy at a prednisone equivalent dose of \\>10 mg daily for at least 1 week or other form of immunosuppressive therapy within 7 days prior to enrollment.\n* Has uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, disseminated intravascular coagulation, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Is at risk for disseminated BCG infection or has previously demonstrated an allergic response to BCG or its components.\n* Has known positive status for human immunodeficiency virus (HIV) or active or chronic Hepatitis (Hep) B or Hep C. Screening is not required.\n* Has any medical condition which in the opinion of the Investigator places the subject at an unacceptably high risk for toxicity.",{"count":55,"type":21},[57],"The goal of this clinical trial is to learn if the vaccine FK-PC101 works to delay or prevent the return of prostate cancer in men who have had surgery to remove their prostate cancer. It will also learn about the safety of FK-PC101. The main questions it aims to answer are:\n\nDoes FK-PC101 delay or prevent the return of prostate cancer following surgery? What medical problems do participants (subjects) have when taking FK-PC101?\n\nResearchers will compare FK-PC101 to current treatment practice to see if FK-PC101 works to prevent or delay the return of prostate cancer following surgery to remove the prostate cancer tumor.\n\nSubjects will:\n\nHave a sample of the prostate cancer tissue collected at the time of surgery to remove this tissue from the body. This tissue will then be used to create a personalized vaccine that is specific to your prostate cancer.\n\nIf randomly selected to receive the vaccine, subjects will receive the vaccine up to 7 times over a 6-month period.\n\nIn addition to the treatment visits for those randomized to receive FK-PC101, there will be up to 4 follow up visits to the clinic over a 22-month (nearly 2 year) period.\n\nFor subjects randomized to receive current treatment practice, they will be asked to attend up to 8 visits over 22 months to track if there is any detectable cancer. Should their prostate cancer return within a year following surgery, they will be eligible to receive FK-PC101, which already had been produced and thus no additional tumor tissue would need to be obtained.\n\nSubjects in both study arms will have regular blood tests and scans to test whether their prostate cancer has returned.",[118,27,336,337,91,338,339],"Prostate Cancers","Prostate Cancer (Post Prostatectomy)","Prostate Cancer Patients Undergoing Radical Prostatectomy","High-risk Prostate Cancer",[341,342,343,123],"Vaccine","Prostatectomy","Autologous","2024-10-17",{"date":346,"type":38},"2024-10-21",{"date":348,"type":38},"2024-10-14",{"date":350,"type":21},"2027-05-04",{"name":352,"class":306},"Cellvax Therapeutics Inc",3]