[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prostate-cancer-crpc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prostate-cancer-crpc":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,76],{"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":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100598880","prostate-cancer-postoperative-stereotactic-body-radiotherapy-with-adaptive-technology-for-minimizing-toxicity-100598880",false,"NCT07077239","Prostate Cancer Postoperative Stereotactic Body Radiotherapy With Adaptive Technology for Minimizing Toxicity","MAgnetic Resonance Imaging or Computed Tomography Guided Stereotactic Body Radiotherapy With Online Adaptive Technology for Minimizing Toxicity During Salvage or AdjUvaNt Radiotherapy for ProstatE Cancer (MASAMUNE)","MASAMUNE","Inclusion Criteria\n\n* History of histologically confirmed, clinical localized adenocarcinoma of the prostate treated with radical prostatectomy with definitive intent.\n* Presence of any ONE of the following:\n\n  1. Adverse pathologic features at the time of prostatectomy (positive surgical margin, pathologic T-stage 3-4 disease, pathologic Gleason score 8-10 disease, OR presence of tertiary Gleason grade 5 disease)\n  2. Documentation of rising prostate-specific antigen on at least two consecutive draws, with the magnitude of prostate-specific antigen exceeding 0.03 ng\u002FmL\n  3. Intermediate- or high-risk Decipher genomic classifier score\n  4. Identification of prostate cancer in ≥1 lymph node at the time of prostatectomy (pN+ disease)\n* CT scan and MRI of the pelvis within 120 days prior to enrollment \\[note: (a) if patient has medical contraindication to MRI, an exemption will be granted and enrollment can proceed; (b) for patients with PSA \\\u003C1.0 ng\u002FmL, the treatment planning CT can substitute for a diagnostic CT scan; (c) a low-field, radiation planning MRI can replace the diagnostic MRI if the patient refuses or cannot obtain a high-field MRI\\].\n* Bone scan OR advanced nuclear imaging study within 120 days prior to enrollment for patients with PSA \\>1.0 ng\u002FmL.\n* Age ≥ 18.\n\n  \\~. KPS ≥ 70 and\u002For ECOG \\\u003C2.\n* Ability to understand, and willingness to sign, the written informed consent\n\nExclusion Criteria\n\n* Patients with any evidence of distant metastases. Note, evidence of lymphadenopathy below the level of the renal arteries can be deemed loco regional per the discretion of the investigator.\n\n  * Patients with neuroendocrine or small cell carcinoma of the prostate\n  * Prior pelvic radiotherapy\n* History of Crohn's Disease, Ulcerative Colitis, or Ataxia Telangiectasia","MALE","18 Years",{"count":20,"type":21},200,"ESTIMATED","5 Years","OBSERVATIONAL","Single-arm, prospective registry study assessing changes in acute patient-reported urinary (GU) and gastrointestinal (GI) quality of life at the 24-month post-treatment time point following magnetic resonance imaging (MRI)-guided or computed tomography (CT)-guided stereotactic body radiotherapy (SBRT) delivered to the prostate bed +\u002F- pelvic lymph nodes. The decision to offer an adaptive treatment will be at the clinician's discretion.",[26],"Prostate Cancer (CRPC)",[28],"prostatectomy","RECRUITING","2025-07-21",{"date":32,"type":33},"2025-07-24","ACTUAL",{"date":35,"type":33},"2025-07-17",{"date":37,"type":21},"2036-08-01",{"name":39,"class":40},"Jonsson Comprehensive Cancer Center","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":60,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":41},"100590838","phase-2-treatment-of-patients-with-progressive-mcrpc-with-177lu-psma-617-100590838","NCT06972628","Treatment of Patients With Progressive mCRPC With 177Lu-PSMA-617","177Lu-PSMA-617 (Pluvicto) for the Treatment of Patients With Progressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Super Scan Bone Scan","Inclusion Criteria:\n\n1. Ability to understand and sign an informed consent form (ICF).\n2. Willingness and ability to comply with study requirements.\n3. Age ≥18 years.\n4. Presence of skeletal metastases with a superscan pattern on a 99mTc-MDP\u002FHDP bone scan, defined by significantly increased skeletal radioisotope uptake relative to soft tissues and faint or absent renal activity.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n6. Hemoglobin ≥9.0 g\u002FdL.\n7. Platelet count ≥90 × 10⁹\u002FL.\n8. White blood cell count ≥2.0 × 10⁹\u002FL, absolute neutrophil count (ANC) \\>1.5 × 10⁹\u002FL.\n\n   o These hematologic criteria must be met without recent transfusions (within 28 days prior to the first study treatment) or growth factor support (within 21 days).\n9. Serum\u002Fplasma creatinine ≤1.5 × upper limit of normal (ULN).\n10. Histological, pathological, or cytological confirmation of prostate cancer.\n11. Positive PSMA PET\u002FCT scan showing at least one PSMA-positive metastatic lesion.\n12. Castrate-level serum\u002Fplasma testosterone (\\\u003C50 ng\u002FdL or \\\u003C1.7 nmol\u002FL).\n13. Prior treatment with at least one androgen receptor-axis-targeted therapy (ARAT).\n\nExclusion Criteria:\n\n1. Prior treatment with radiopharmaceuticals (e.g., Strontium-89, Samarium-153, Rhenium- 186, Rhenium-188, Radium-223, hemi-body irradiation) within six months before start of treatment under this protocol.\n2. Prior PSMA-targeted radioligand therapy.\n3. Systemic anti-cancer therapy (e.g., chemotherapy, immunotherapy, monoclonal antibodies) within four weeks before screening visit.\n4. Known hypersensitivity to PLUVICTO or its components.\n5. Concurrent treatment with other cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy.\n6. Renal impairment (estimated glomerular filtration rate \\\u003C60 mL\u002Fmin), hemoglobin \\\u003C9 g\u002FdL, ANC \\\u003C1.5 × 10⁹\u002FL, or platelets \\\u003C 90 × 10⁹\u002FL.\n7. History of CNS metastases unless treated and stable for 6 months, with no ongoing corticosteroid use.\n8. Symptomatic or impending spinal cord compression.\n9. Other malignancies impacting life expectancy or interfering with study assessments. Exceptions include non-melanoma skin cancer or superficial bladder cancer that has been adequately treated.\n10. Major surgery within 30 days prior to enrollment.\n11. Plans to conceive or father a child during treatment and up to six months post-treatment.",{"count":50,"type":21},30,"INTERVENTIONAL",[53],"PHASE2","The purpose of this study is to evaluate the safety and tolerability of Lutetium-177-PSMA-617 (PLUVICTO) in patients with metastatic castration-resistant prostate cancer (mCRPC) and extensive bone metastases, which appear as a \"super scan\" pattern on a bone scan.\n\nPluvicto is FDA-approved, but patients with super scan bone scans were previously excluded from the VISION clinical trial, leaving a knowledge gap.\n\nThe study will enroll up to 30 men with metastatic castration-resistant prostate cancer, with an initial dosing approach that differs from the standard dose.\n\nThe safety and tolerability of PLUVICTO will be evaluated in this study, with a focus on identifying the optimal dose for this population.\n\nThis study addresses an important gap in understanding how Pluvicto performs in mCRPC patients with super scan findings.",[56,57,26,58,59],"Metastatic Castration-Resistant Prostate Cancer","Prostate Cancer Patients With Bone Metastasis","Prostate Cancer","Prostate Cancer Metastatic",[61,62,63,64,65,66],"Metastatic Castration-Resistant Prostate Cancer (mCRPC)","super scan bone scan","Prostate Cancer patients with bone metastasis","prostate cancer (CRPC)","Prostate cancer","Prostate cancer metastatic","2025-05-12",{"date":69,"type":33},"2025-05-15",{"date":71,"type":21},"2025-05-23",{"date":73,"type":21},"2029-04-01",{"name":75,"class":40},"Ebrahim S Delpassand",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":51,"phases":84,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":41},"100568579","phase-1-study-on-human-bioequivalence-of-triprerelin-acetate-for-injection-100568579","NCT06683066","Study on Human Bioequivalence of Triprerelin Acetate for Injection","Inclusion Criteria:\n\n1\\. Voluntarily participate in the test, and sign the informed consent, and fully understand the test content, process and possible adverse reactions; 2. Male participants aged 18 years and older, male weight ≥50.0kg, body mass index (BMI) of 19 to 30kg\u002Fm2; 3. Patients with histopathologically diagnosed prostate cancer who were judged by investigators to be suitable for endocrine therapy, including 1 who had not received gonadotropin-releasing hormone analogues (GnRHa); 2 Patients receiving stable treatment with triprerelin acetate for injection; 3 Patients who have previously been treated with a gonadotropin-releasing hormone analogue (GnRHa) and who have been evaluated by the investigators as suitable for treatment with GNRHA; 4. ECOG score ≤2 points; 5. Expected survival ≥ 9 months; 6. Adequate hematopoietic function, liver and kidney function; 7. The subject is willing to have no family planning, sperm donation plan and voluntarily use one or more non-drug contraceptive methods (such as barrier contraception or abstinence) for 6 months from the signing of the information to the end of the drug administration.\n\n\\-\n\nExclusion Criteria:\n\n1\\. Patients who have previously undergone surgical castration; 2. Patients with known or suspected definite signs and symptoms of BMS or definite diagnosis of BMS; 3. Concurrent malignant tumors other than prostate cancer within 5 years, excluding basal cell carcinoma or squamous cell carcinoma of the skin that has been surgically removed; 4. Patients who have previously undergone adrenalectomy or pituitary resection or have pituitary disease; 5. Those who plan to undergo prostate surgery or other major surgical treatment during the study period (except urinary tract obstruction removal); 6. Patients with past or suspected spinal cord compression or urinary tract obstruction leading to kidney injury or patients at risk of developing such phenomena; 7. Patients with severe cardiovascular and cerebrovascular diseases, including but not limited to: patients with poorly controlled hypertension (systolic blood pressure \\>160 mmHg and\u002For diastolic blood pressure \\>100 mmHg under regular medication control); Patients with a history of hypertensive crisis or hypertensive encephalopathy; Severe cardiovascular and cerebrovascular disease, such as myocardial infarction, or heart failure classified by the New York Heart Association ≥II, within 6 months before the first administration of the investigational drug; Severe cardiac arrhythmia that cannot be controlled by medication (including QTc interval ≥470 ms), or congenital long QT syndrome; 8. Type I diabetes; Patients with type 2 diabetes with poor glycemic control (HbA1c\\>8.0% at screening); 9. Hepatitis B Surface antigen (HBsAg) test positive with HBV-DNA greater than 104copies\u002FmL(or 2000IU\u002FmL), or hepatitis C antibody positive with HCV-RNA test positive, or HIV antibody positive, Or syphilis antibody positive and RPR or TRUST positive; 10. Previous history of severe asthma or severe anaphylaxis or severe urticaria and\u002For vasogenic edema; 11. Persons known to be allergic to any component of triprerelin acetate for injection or to GnRH analogues; 12. People who are currently abusing drugs, drugs or alcohol (drinking an average of more than 14 units of alcohol per week, 1 unit =360 mL of beer or 45 mL of 40% alcohol spirits or 150 mL of wine); 13. A drug known to prolong the QT interval or induce tip torsive ventricular tachycardia (e.g., Class IA (e.g., quinidine, propylamine) or Class III (amiodarone, sotalol, dofetilide, ibutilide) was taken for 4 weeks or 5 half-lives (whichever is longer) prior to administration (including induction and trial) Psychotics, methadone, moxifloxacin, antipsychotics, etc; 14. Those who participate in other clinical trials and receive clinical trial drugs or devices within 1 month before administration (including the introduction period and the trial period); 15. Those who received any vaccine within 4 weeks prior to administration (including the introduction and trial period); 16. People who ingested special diet (such as grapefruit, pomelo and its products) within 48 hours before administration (including the introduction period and the trial period), or other factors that may affect drug absorption, distribution, metabolism, excretion and so on; 17. Those who donated blood or lost a large amount of blood (≥200mL) within 1 month before administration (including the introduction period and the trial period), and received blood transfusion or platelet transfusion ≥2 therapeutic amounts (1 therapeutic amount =12U platelet); 18. Patients with difficulty in venous blood collection; 19. Other circumstances in which the investigator considers it inappropriate to participate in the clinical trial, or in which the participant's participation in the trial may affect the trial results or his or her own safety.\n\n\\-",{"count":83,"type":21},120,[85],"PHASE1","To investigate the pharmacokinetics of triprerelin acetate for injection and triprerelin acetate (Dufferin ®) for injection of reference preparation in patients with prostate cancer by single intramusculodynamic injection in fasting state, and to evaluate the bioequivalence of the two formulations in fasting state.",[26],"2024-11-08",{"date":90,"type":33},"2024-11-12",{"date":92,"type":21},"2024-12-04",{"date":94,"type":21},"2025-09-04",{"name":96,"class":40},"The Affiliated Hospital of Qingdao University"]