[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stage-iib-prostate-cancer-ajcc-v8\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stage-iib-prostate-cancer-ajcc-v8":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,67],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100504723","early-phase-1-rhpsma-73-pet-mri-imaging-for-the-detection-of-prostate-cancer-among-men-who-are-otherwise-candidates-for-active-surveillance-100504723",false,"NCT05852041","rhPSMA-73 PET-MRI Imaging for the Detection of Prostate Cancer Among Men Who Are Otherwise Candidates for Active Surveillance","A Pilot Study of rhPSMA-PET MRI Imaging for the Detection of Clinically Actionable Prostate Cancer Among Men Who Are Otherwise Candidates for Active Surveillance","Inclusion Criteria:\n\n* Healthy men (Eastern Cooperative Oncology Group \\[ECOG\\] 0-1), \\>= 18 years old with at least 10 year life expectancy\n* Histologically proven Gleason Grade Group 1 or 2 adenocarcinoma of the prostate\n* Last prostate cancer containing biopsy performed within 3-15 months (mo.) prior to screening. Biopsy must have been \\>= 10 core biopsy and informed by prior mpMRI\n* Prostate cancer categorized as low risk or favorable risk by National Comprehensive Cancer Network (NCCN) criteria (low risk is defined as T1c-T2a, prostate-specific antigen \\[PSA\\] \\\u003C 10ng\u002Fml, Gleason Grade Group 1 \\[Gleason 3+3=6\\] disease) and favorable intermediate risk as having no more than one of the following intermediate risk features, clinical T2b-T2c disease, PSA 10-20ng\u002Fml, Gleason Grade Group 2 \\[Gleason score 3+4=7\\])\n* Decipher genomic classifier score from prior biopsy \\>= 0.45\n* Institutional Review Board (IRB)-\u002FIndependent Ethics Committee (IEC)-approved written informed consent and privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures\n* Concurrent diseases and malignancies are permitted\n* Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on the study\n* Willing to undergo prostate biopsy prior to non-surgical treatment of prostate cancer and within 90 days of PET-MRI imaging\n\nExclusion Criteria:\n\n* Prior radiotherapy, surgery, chemotherapy, or hormonal therapy for prostate cancer\n* NCCN very low risk category (T1c and Gleason Grade Group 1 \\[Gleason score 3+3=6\\], PSA \\\u003C 10 ng\u002FmL, fewer than 3 prostate biopsy cores positive, =\\\u003C 50% cancer in any core, PSA density \\\u003C 0.15 ng\u002FmL\u002Fg)\n* Decipher score \\\u003C 0.45\n* Prior bladder outlet procedure (i.e,. holmium laser enucleation of the prostate \\[HoLEP\\], transurethral resection of the prostate \\[TURP\\], Urolift, Rezum)\n* Prohibited medications: use of 5 alpha reductase inhibitor or androgen deprivation therapy (i.e., leuprolide, relugolix) within 1 month of screening\n* Contra-indication or relative contra-indication to MRI (i.e., pacemaker)\n* History of hip replacement\n* Subject has received investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening",true,"MALE","18 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","This clinical trial evaluates whether positron emission tomography-magnetic resonance imaging (PET-MRI) using the radioactive drug radiohybrid prostate-specific membrane antigen (rhPSMA)-7.3 may help in detecting higher grade or stage disease in men with low and favorable intermediate risk prostate cancer who are candidates for active surveillance. A PET scan is a test that uses a radioactive drug and a computer to create images of how organs and tissues in the body are functioning. The radioactive drug used in this study, rhPSMA-7.3, attaches to the abnormal cells in the body at a different rate than normal cells which allows the scanner to create a detailed picture of how the body is working. An MRI scan uses strong magnets and computers to create detailed images of the soft tissue in your body. A multiparametric (mp)MRI is a type of MRI scan that creates a more detailed picture of the prostate gland. Using rhPSMA-73 with PET-MRI and mpMRI may be more effective in detecting higher grade or stage disease in men with low and favorable intermediate risk prostate cancer.",[27,28,29,30],"Prostate Adenocarcinoma","Stage I Prostate Cancer AJCC v8","Stage IIA Prostate Cancer AJCC v8","Stage IIB Prostate Cancer AJCC v8","RECRUITING","2026-06-30",{"date":34,"type":35},"2026-07-02","ACTUAL",{"date":37,"type":35},"2023-06-07",{"date":39,"type":21},"2035-06-07",{"name":41,"class":42},"Northwestern University","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":43},"100541510","phase-2-effects-of-relugolix-vs-leuprolide-on-cardiac-function-in-patients-with-prostate-cancer-100541510","NCT06330805","Effects of Relugolix vs Leuprolide on Cardiac Function in Patients With Prostate Cancer","A Comparison of Orgovyx (Relugolix) vs Eligard (Leuprolide) on Cardiovascular Function and Biomarkers During Standard of Care Combined ADT (Androgen Deprivation Therapy)-Radiation for Prostate Cancer","Inclusion Criteria:\n\n* Pathologically proven diagnosis of adenocarcinoma of the prostate within 270 days prior to registration.\n* Unfavorable intermediate risk prostate cancer, defined as having ALL the following bulleted criteria:\n\n  * Has at least one intermediate risk factor (IRF):\n\n    * Prostate-specific antigen (PSA) 10-20 ng\u002FmL\n    * Clinical stage tumor (T)2b-c (digital rectal exam \\[DRE\\] and\u002For imaging) by American Joint Committee on Cancer (AJCC) 8th edition\n    * Gleason Score 7 (Gleason 3+4 or 4+3 \\[International Society of Urological Pathology \\[ISUP\\] grade group 2-3\\])\n  * Has one or more of the following \"unfavorable\" intermediate-risk designators:\n\n    * \\> 1 IRF\n    * Gleason 4+3=7 (ISUP grade group 3)\n    * ≥ 50% of biopsy cores positive\n\n      * Biopsies may include \"sextant\" sampling of right\u002Fleft regions of the prostate, often labeled base, mid-gland and apex. All such \"sextant\" biopsy cores should be counted. Men may also undergo \"targeted\" sampling of prostate lesions (guided by MRI, ultrasound or other approaches). A targeted lesion that is biopsied more than once and demonstrates cancer (regardless of number of targeted cores involved) should count as a single additional positive core sampled and positive. In cases of uncertainty, count the biopsy sampling as sextant core(s).\n    * Absence of high-risk features\n* Appropriate stage based on the following diagnostic workup:\n\n  * History\u002Fphysical examination within 120 days prior to registration\n  * Negative bone imaging (M0) with Tc-99m bone scan or fluciclovine (18F) sodium fluoride (NaF) positron emission tomography (PET) within 120 days prior to registration\n  * Clinically negative lymph nodes (N0) as established by conventional imaging (pelvic +\u002F- abdominal CT or MRI), within 120 days prior to registration (lymph nodes equivocal or questionable by imaging are eligible if the nodes are ≤ 1.0 cm in short axis and\u002For if biopsy is negative)\n  * Prostate specific membrane antigen (PSMA) or fluciclovine PET negative for nodal or distant metastatic disease is an acceptable substitute for the above bone and pelvic imaging\n* Age ≥ 18\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 within 120 days prior to registration.\n* Non-castrate testosterone level (\\> 50 ng\u002FdL) within 120 days prior to registration.\n* Absolute neutrophil ≥ 1,000 cells\u002Fmm\\^3 (within 120 days prior to registration)\n* Hemoglobin ≥ 10 g\u002FdL (within 120 days prior to registration)\n* Platelet count ≥ 100,000 cells\u002Fmm\\^3 (within 120 days prior to registration)\n* Creatinine clearance (CrCl) ≥ 30 mL\u002Fmin estimated by Cockcroft-Gault Equation (within 120 days prior to registration)\n\n  * For African American patients, CrCl ≥ 30 mL\u002Fmin is estimated by the alternative formula that takes race into account\n* Total bilirubin: 1.5 ≤ institutional upper limit of normal (ULN) (within 120 days prior to registration)\n* Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT)(serum glutamic-pyruvic transaminase \\[SGPT\\]) ≤ 2.5 × institutional ULN (within 120 days prior to registration)\n* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Note: HIV testing is not required for eligibility for this protocol.\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n\nNote: Known positive test for hepatitis B virus surface antigen (HBV sAg) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy. Patients who are immune to hepatitis B (anti-Hepatitis B surface antibody positive) are eligible (e.g. patients immunized against hepatitis B).\n\n* For patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n\n  * Note: Known positive test for hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy.\n* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information.\n\nExclusion Criteria:\n\n* Previous radical surgery (prostatectomy) or any form of curative-intent ablation whether focal or whole-gland (e.g., cryosurgery, High-intensity focused ultrasound (HIFU), laser thermal ablation, etc.) for prostate cancer.\n* Definitive clinical or radiologic evidence of metastatic disease (M1).\n* Prior invasive malignancy (except non-melanomatous skin cancer) or hematologic malignancy unless disease free for a minimum of 3 years.\n* Prior radiotherapy to the prostate\u002Fpelvis region that would result in overlap of radiation therapy fields.\n* Previous bilateral orchiectomy.\n* Previous hormonal therapy, such as luteinizing hormone-releasing hormone (LHRH) agonists (e.g., leuprolide, goserelin, buserelin, triptorelin) or LHRH antagonist (e.g. degarelix), anti-androgens (e.g., flutamide, bicalutamide, cyproterone acetate). ADT started prior to study registration is not allowed.\n* Prior use of 5-alpha-reductase inhibitors is allowed; however, it must be stopped ≥ 30 days prior to the pre-registration PSA measure for determining enrollment eligibility.\n* Prior testosterone replacement therapy is allowed; however, any replacement therapy must be stopped for at least 1 year prior to registration.\n* Severe, active co-morbidity defined as follows:\n\n  * Current\u002Funcontrolled angina or arrhythmias\n  * New York Heart Association Functional Classification II-IV (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.)\n  * History of any condition that in the opinion of the investigator, would preclude participation in this study\n* Patients with significant obstructive urinary symptoms that are suspected to be secondary to prostate cancer and\u002For benign prostatic hypertrophy.\n* Disabilities that prevent performing moderate intensity exercise test with exercise (treadmill) stress test and muscle function tests (walking\u002Fgait assessments and grip strength).\n* Patients unable to tolerate MRI (e.g. claustrophobia), has contraindications to MRI (e.g. metals and implants incompatible with MRI), body habitus preventing MRI scanning, or allergy to gadolinium-based contrast.\n* Significant uncontrolled gastrointestinal (e.g. Crohn's disease, ulcerative colitis) or metabolic disease (e.g. diabetes, hyperlipidemia).\n* Active inflammatory or immune-related disease treated with steroids or immunosuppressive agents.\n* Inability to swallow oral pills.\n* High risk features, which includes any of the following:\n\n  * Gleason 8-10 \\[ISUP grade group 4-5\\]\n  * PSA\\>20\n  * cT3-4 by digital exam OR gross extra-prostatic extension on imaging \\[indeterminate MRI evidence will not count and the patient will be eligible\\]",{"count":52,"type":21},70,[54],"PHASE2","This phase II trial compares the effect of relugolix to leuprolide on cardiac function and performance in patients with prostate cancer. Androgen deprivation therapy (ADT) has been a key component for the treatment of advanced prostate cancer for decades. The term androgen deprivation therapy means lowering a man's testosterone. Long-term studies show that ADT may contribute to a detriment to cardiac health and predisposes men to developing cardiac diseases. Recent studies suggest that men taking relugolix for treatment of prostate cancer may have a lower risk of developing cardiovascular problems, but more studies are needed to understand this observation, and there are currently no studies reporting the direct impact of ADT (relugolix, versus the more-commonly used leuprolide) on cardiac function and outcomes.\n\nParticipants will receive definitive radiotherapy for unfavorable intermediate risk prostate cancer and 6-month ADT (either relugolix or leuprolide). In addition, participants will undergo the following:\n\n1. Comprehensive cardiac and exercise testing before and after starting ADT\n2. Completion of quality-of-life questionnaires at specific intervals during the study period\n3. Provide blood samples at specific intervals during the study period to test for changes in steroid levels and certain biomarkers",[27,30,57],"Stage IIC Prostate Cancer AJCC v8","2026-03-05",{"date":60,"type":35},"2026-03-09",{"date":62,"type":35},"2024-08-12",{"date":64,"type":21},"2027-12-31",{"name":66,"class":42},"Ohio State University Comprehensive Cancer Center",{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":22,"phases":76,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":94},"100531862","phase-3-sbrt-versus-hypofractionated-radiotherapy-for-biochemically-recurrent-or-oligometastatic-prostate-adenocarcinoma-100531862","NCT06205316","SBRT Versus Hypofractionated Radiotherapy for Biochemically Recurrent or Oligometastatic Prostate Adenocarcinoma","Randomized Phase III Trial of SBRT Versus Hypofractionated Radiotherapy for Salvage of Biochemically Recurrent or Oligometastatic Prostate Adenocarcinoma After Radical Prostatectomy","Inclusion Criteria:\n\n* Histologically confirmed prostate adenocarcinoma at the time of surgery\n* Pathologic stages T2-T3b, Nx or N0-1, M0-1 as staged by the pathology report (American Joint Committee on Cancer \\[AJCC\\] Criteria 8th edition \\[Ed.\\])\n* PSA post radical prostatectomy ≥ 0.1 and \\\u003C 2.0 ng\u002FmL ≤ 90 days prior to enrollment, obtained ≥ 6 weeks after surgery\n* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 assessed ≤ 90 days of enrollment\n* Patients must sign institutional review board (IRB) approved study specific informed consent\n* Patients must complete all required pre-entry tests within the specified time frames\n* Patients must be able to start treatment (ADT or radiation) ≤ 120 days of study registration\n* Patients must be ≥ 18 years old\n* Prostate cancer up to oligometastatic disease, up to 5 sites\n\nExclusion Criteria:\n\n* Previous pelvic radiation\n* Prior androgen deprivation therapy for prostate cancer and PSA ≥ 0.1 ng\u002FmL\n* Active rectal diverticulitis, Crohn's disease affecting the rectum, or ulcerative colitis (non-active diverticulitis and Crohn's disease not affecting the rectum are allowed)\n* Prior systemic chemotherapy for prostate cancer\n* History of proximal urethral stricture requiring dilatation\n* Major medical, addictive, or psychiatric illness which in the investigator's opinion, will prevent the consent process, completion of the treatment and\u002For interfere with follow-up. (Consent by legal authorized representative is not permitted for this study)\n* History of myocardial infarction or decompensated congestive heart failure (CHF) within the last 6 months\n* On a transplant list\n* More than oligometastatic disease \\> 5 metastatic sites",{"count":75,"type":21},118,[77],"PHASE3","This phase III trial tests the side effects of stereotactic body radiation therapy (SBRT) compared to hypofractionated radiotherapy for treating patients with prostate adenocarcinoma that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to a limited number of sites (oligometastatic). SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumors cells and have fewer side effects. SBRT may work just as well as hypofractionated radiation therapy at treating patients with biochemically recurrent or oligometastatic prostate cancer, but with a shorter treatment time and possibly fewer side effects.",[80,81,82,30,57,83,84],"Biochemically Recurrent Prostate Carcinoma","Oligometastatic Prostate Carcinoma","Recurrent Prostate Adenocarcinoma","Stage III Prostate Cancer AJCC v8","Stage IV Prostate Cancer AJCC v8","2026-01-16",{"date":87,"type":35},"2026-01-20",{"date":89,"type":35},"2024-01-22",{"date":91,"type":21},"2030-01-22",{"name":93,"class":42},"Mayo Clinic",6]