[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prostate-cancer-recurrent\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prostate-cancer-recurrent":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,50,72,97,139,159,199,226,251,282,304,330],{"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":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100640146","phase-2-prostate-specific-membrane-antigen-psma-imaging-for-detection-of-residual-and-metastatic-prostate-cancer-100640146",false,"NCT07593079","Prostate Specific Membrane Antigen (PSMA) Imaging for Detection of Residual and Metastatic Prostate Cancer","Optimizing PSMA Imaging for Enhanced Detection of Residual and Metastatic Prostate Cancer in Low PSA Recurrence (OPERA) Study","Inclusion Criteria:\n\n* Histologically or cytologically confirmed biochemically recurrent prostate cancer, with original diagnosis no more than 2 years from date of consent.\n* Intermediate unfavorable or high-risk prostate cancer.\n* All patients under consideration for radiation therapy, either at the time of first recurrence or in salvage radiation therapy will be included.\n* Patients who have started bicalutamide up to a maximum of 3 days prior to randomization will be allowed to be on protocol. Otherwise, a washout period of at least 42 days will be required.\n* Biological males, at least 18 years of age.\n* Prostate specific antigen (PSA) \\\u003C 1.0 ng\u002FmL.\n* Agreement to adhere to Lifestyle Considerations throughout study duration\n* Ability to understand and willingness to sign an IRB approved written informed consent document.\n\nExclusion Criteria:\n\n* Patients currently on androgen deprivation therapy (ADTs).\n* Currently receiving any other investigational agents.\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to POSLUMA, furosemide, bicalutamide, or other agents used in the study.","MALE","18 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a randomized, open-label, pilot study assessing the impact of a short course of bicalutamide on PSMA expression in patients with prostate cancer belonging to the intermediate unfavorable or high risk group, who have low levels of PSA. Adult patients with biochemically recurrent prostate cancer (BCR PCa) who have a PSA of less than 1.0 ng\u002FmL and who have undergone complete prostatectomy and\u002For will be undergoing radiotherapy, in combination with standard of care bicalutamide, will be recruited to this study. Patients will be randomized in a 1:1 ratio into Group A (baseline PSMA PET\u002FCT only with bicalutamide standard of care) or Group B (baseline PSMA PET\u002FCT and an additional PSMA PET\u002FCT after 2 weeks of bicalutamide).",[26,27,28,29,30],"Prostate Cancer","Recurrent Prostate Cancer","Metastatic Prostate Cancer","Prostate Cancer Recurrent","Prostate Cancer Metastatic",[32,33,34,35,36],"Prostate cancer","Low PSA","PSMA PET","BCR","Bicalutamide","NOT_YET_RECRUITING","2026-06-29",{"date":40,"type":41},"2026-07-01","ACTUAL",{"date":43,"type":20},"2026-07-31",{"date":45,"type":20},"2027-10-31",{"name":47,"class":48},"Washington University School of Medicine","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":49},"100555167","salvage-mr-guided-high-dose-rate-brachytherapy-for-prostate-bed-recurrence-after-radiotherapy-in-the-psma-pet-scan-era-100555167","NCT06508567","Salvage MR-guided High-Dose-Rate Brachytherapy for Prostate Bed Recurrence After Radiotherapy in the PSMA PET Scan Era","SHAPE-PSMA","Inclusion Criteria:\n\n1. Patients who received previous RT to the prostate bed +\u002F- pelvic nodal regions\n2. Prostate-bed recurrence identified by biopsy and\u002For MRI and\u002For PSMA-PET scan\n3. At least two continuous PSA elevations post RT and PSA above 0.2 ng\u002Fdl\n4. With or without ADT PSA doubling time from nadir greater than 6 months\n5. ECOG 0-2\n6. Age greater than 18 years\n\nExclusion Criteria:\n\n1. Radiological (e.g. PSMA PET, CT, MRI or bone scan) evidence of or distant metastases\n2. History of ≥G3 gastrointestinal (GI) and genitourinary (GU) toxicities following RT\n3. Any contraindications to MR and\u002For brachytherapy",{"count":19,"type":20},[59],"NA","This is an interventional, single-centre, single-arm, non-randomized, prospective, feasibility trial investigating salvage MR-guided High-Dose-Rate brachytherapy for prostate bed recurrence after postoperative radiotherapy.",[29,26],"RECRUITING","2026-05-21",{"date":65,"type":41},"2026-05-26",{"date":67,"type":41},"2024-08-08",{"date":69,"type":20},"2031-03-01",{"name":71,"class":48},"University Health Network, Toronto",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":80,"minAge":17,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":21,"phases":83,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":49},"100442041","phase-1-coast-therapy-in-advanced-solid-tumors-and-prostate-cancer-100442041","NCT05036226","COAST Therapy in Advanced Solid Tumors and Prostate Cancer","Combination of Autophagy Selective Therapeutics (COAST) in Advanced Solid Tumors or Relapsed Prostate Cancer, A Phase I\u002FII Trial","COAST","Inclusion Criteria:\n\n1. Patient must have advanced solid tumor cancer of any type (Phase I) or advanced prostate cancer (Phase II). Prostate cancer patients must have a PSA of at least 0.1 ng\u002FmL.\n2. Tissue diagnosis documented by pathology report, or clinic note attesting to same.\n3. Measurable \u002F evaluable tumor by RECIST, quantitative blood biomarker, or radionuclide imaging\n4. Voluntary, signed and dated, Institutional Review Board (IRB) approved consent form in accordance with regulatory and institutional guidelines.\n5. Documented progression of disease during treatment with one or more standard systemic regimens. Single or multiple regimens of chemotherapy, hormone suppression therapy, radiation therapy, surgery, immunotherapy, or adoptive cell therapy are allowed.\n6. 18 years of age or older.\n7. ECOG performance status of 0-2.\n8. Bilirubin ≤ 1.5 times upper limit of normal (ULN) and AST \u002F ALT ≤ 3 times ULN. Subjects with Gilbert's syndrome may be included if the total bilirubin is \\\u003C 3 times ULN and the direct bilirubin is within normal limits.\n9. Serum creatinine ≤ 1.5 times ULN.\n10. Absolute neutrophil count (ANC) ≥ 1,000 cells \u002F mm3\n11. Platelet count ≥ 75,000 cells \u002F mm3\n12. Hemoglobin ≥ 9 g\u002F dL.\n13. Fasting glucose ≤ 160 mg\u002FdL or non-fasting glucose ≤ 200 mg\u002FdL.\n14. Urinalysis with no clinically significant abnormalities.\n15. Adequately controlled blood pressure as determined by the treating investigator.\n16. Subjects with the potential to produce children must agree to effective contraceptive method use during study participation.\n17. Patients requiring narcotic analgesics must be on stable doses for at least 2 weeks prior to study entry.\n18. Patients being considered for a dose level containing nelfinavir mesylate must discontinue any statin use within 48 hours of beginning study treatment.\n\nExclusion Criteria:\n\n1. New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or history of ischemia on ECG.\n2. Underlying psychiatric disorder requiring hospitalization within the last two years.\n3. Clinically significant neurological disorder (Parkinson's disease, dementia, multiple sclerosis), as determined by the enrolling investigator.\n4. Active, uncontrolled bacterial, viral, or fungal infection, requiring systemic therapy.\n5. Treatment with local or systemic radiation therapy, surgery, or investigational therapy within 28 days prior to registration.\n6. Unwillingness or inability to comply with procedures required in this protocol.\n7. Serious nonmalignant disease that could compromise protocol objectives in the opinion of the Investigator.\n8. Patients who are receiving, coumadin, apixaban, argatroban or rivaroxaban.\n9. Patients who are currently participating in any other clinical trial of an investigational product.\n10. Any other mental incapacitation or psychiatric illness that would preclude study participation, as determined by the enrolling investigator.\n11. Prisoners or patients who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.","ALL",{"count":82,"type":20},76,[84,23],"PHASE1","The purpose of this Phase I\u002FII study is to determine the safety and effectiveness of up to 5 study drugs used together for the treatment of solid tumor cancers. The drugs are hydroxychloroquine, metformin, sirolimus, dasatinib and nelfinavir and are given orally.",[29,87],"Solid Tumor, Adult","2026-05-11",{"date":90,"type":41},"2026-05-13",{"date":92,"type":41},"2022-03-03",{"date":94,"type":20},"2028-05-21",{"name":96,"class":48},"Medical University of South Carolina",{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":107,"phases":4,"briefSummary":108,"conditions":109,"keywords":112,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":138},"100593295","lab-research-using-mini-tumors-to-study-prostate-cancer-treatments-100593295","NCT07004582","Lab Research Using Mini-tumors to Study Prostate Cancer Treatments","Preclinical ex Vivo Patient-derived 3D Cultures for the Prediction of Prostate Cancer Treatment Response","PR3DICT","Inclusion Criteria:\n\n* Patients aged 18 years or older\n* Patients with prostate cancer\n* Patients planned for HDR brachytherapy treatment for high-risk or recurrent prostate cancer or transperineal prostate biopsy with MRI-suspected metastatic prostate cancer with at least clinical stage T3-4.\n\nExclusion Criteria:\n\n* Patients younger than 18 years\n* Patients of whom it is not possible to obtain left-over tissue as part of the normal clinical treatment procedure (e.g., if all tumor material is required for the pathologist to make a diagnosis, to stage the patient or to perform a molecular diagnosis).",{"count":106,"type":20},600,"OBSERVATIONAL","For men with an aggressive form of prostate cancer, finding the right and effective treatment right away is challenging. Many of these men face a high risk of cancer recurrence: about half experience a relapse after surgery, and more than a third after undergoing radiation therapy. Men with metastatic prostate cancer have particularly poor prognoses, with a five-year survival rate of only 30% to 50%. In short, it is difficult to predict which treatment, or combination of treatments, will lead to longer survival for this group of men with aggressive (metastatic) prostate cancer.\n\nIn the laboratory, it is possible to grow small samples of tumors into 3D mini-tumors. These mini-tumors retain the characteristics of the patient's original tumor tissue. Various treatments can be tested on these 3D mini-tumors to determine which therapy is most effective for each individual case. There are currently two techniques available for creating these 3D mini-tumors in the lab. In this project, we aim to investigate which of these two techniques works best in order to test and personalize treatments.",[26,110,29,111],"Prostate Cancer Metastatic Disease","Advanced Prostate Cancer",[113,114,32,115,116,117,118,119,120,121,122,123,124,125,126,127,128],"Advanced prostate cancer","Metastatic prostate cancer","Patient-tailored treatment","Precision Medicine","Ex vivo prediction platform","Personalized medicine","Drug Screening Assays","Three-Dimensional Culture Techniques","Organoids","Tumoroids","Tumor replicas","Prostatic Neoplasms","Neoplasm Metastasis","Advanced Cancer","Treatment Outcome","Human Tissue Culture Techniques","2026-04-20",{"date":131,"type":41},"2026-04-23",{"date":133,"type":41},"2026-03-15",{"date":135,"type":20},"2031-12-30",{"name":137,"class":48},"Maastricht Radiation Oncology",3,{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":107,"phases":4,"briefSummary":148,"conditions":149,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":4},"100630300","18f-psma-petct-versus-ct-alone-in-assessment-of-prostatic-cancer-patients-100630300","NCT07485881","18F-PSMA PET\u002FCT Versus CT Alone in Assessment of Prostatic Cancer Patients","18F-PSMA PET\u002FCT Versus CT Alone in Initial Staging, Assessment of Therapy Response and Evaluation of Biochemical Recurrence in Prostatic Cancer Patients","Inclusion Criteria:\n\nPatients with known prostate cancer referred for 18-F PSMA PET\u002FCT study\n\nExclusion Criteria:\n\n* Patients with claustrophobia\n* Patients refuse to do the scan",{"count":147,"type":20},59,"To compare the diagnostic performance of 18-F PSMA PET\u002FCT and CT alone in initial staging, assessment of therapy response, as well as evaluation of biochemical recurrence of prostatic cancer patients\n\nThe main question it aims to answer is:\n\nDoes 18-F PSMA PET\u002FCT have a superior role over CT in evaluation of prostatic cancer patients?",[26,30,29],"2026-03-17",{"date":152,"type":41},"2026-03-20",{"date":154,"type":20},"2026-05-01",{"date":156,"type":20},"2028-06",{"name":158,"class":48},"Assiut University",{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":16,"minAge":167,"maxAge":4,"enrollmentInfo":168,"targetDuration":4,"studyType":21,"phases":170,"briefSummary":171,"conditions":172,"keywords":189,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":49},"100589690","phase-2-proof-of-concept-trial-to-assess-the-efficacy-and-safety-of-fezolinetant-in-improving-vasomotor-symptoms-in-men-with-prostate-cancer-undergoing-androgen-deprivation-therapy-100589690","NCT06957691","Proof-of-Concept Trial to Assess the Efficacy and Safety of Fezolinetant in Improving Vasomotor Symptoms in Men With Prostate Cancer Undergoing Androgen Deprivation Therapy","Proof-of-Concept Trial to Assess the Efficacy and Safety of Fezolinetant in Improving Vasomotor Symptoms in Men With Prostate Cancer Undergoing Androgen Deprivation Therapy (Fezo-ADT Trial)","Fezo-ADT","Inclusion Criteria:\n\n* Male sex\n* Age 40 years and older\n* Diagnosis of prostate cancer\n* Androgen deprivation therapy\n* Presence of 5 or more moderate-to-severe hot flashes per day or 35 or more moderate-to-severe hot flashes per week\n* Ability to sign the inform consent\n* Willing to use reliable methods of contraception if partner is of childbearing age\n* Ability to record hot flashes electronically\n\nExclusion Criteria:\n\n* Use of abiraterone acetate\n* Use of docetaxel and other chemotherapeutic agents\n* Liver cirrhosis\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above the upper limit of normal\n* Total bilirubin above the upper limit of normal\n* Glomerular filtration rate \\\u003C 30 mL\u002Fmin\n* Use of selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, tricyclic antidepressants, sedatives, or hypnotics\n* Use of over-the-counter hormonal agents or herbal compounds\n* Current use of CYP1A2 inhibitors\n* Ingestion of alcohol within 2 weeks prior to the baseline visit\n* Inability to abstain from alcohol use during the study period.","40 Years",{"count":169,"type":20},60,[23],"The goal of this clinical trial is to learn if fezolinetant can treat hot flashes (vasomotor symptoms) in men with prostate cancer undergoing androgen deprivation therapy.\n\nThe main questions it aims to answer are:\n\n* Does fezolinetant improve the frequency and severity of hot flashes?\n* Does fezolinetant cause any harm to the liver?\n* Does fezolinetant improve quality of life, sleep quality, fatigue, mood, sexual function, and metabolic parameters?\n\nResearchers will compare how people respond to fezolinetant versus a placebo, which does not contain any active medicine.\n\nParticipants will:\n\n* Take fezolinetant or a placebo every day for 4 weeks\n* Visit the clinic once every 2 weeks for checkups and tests\n* Keep a diary of the number of times and intensity that they experience hot flashes",[26,173,110,29,174,175,176,177,178,179,180,181,182,183,184,185,186,187,188],"Prostate Cancer (Adenocarcinoma)","Prostate Carcinoma","Prostate Neoplasm","Prostate Adenocarcinoma","Prostate Cancer With Bone Metastasis","Vasomotor Disturbance","Vasomotor Symptoms","Vasomotor Symptoms (VMS)","Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men","Vasomotor Symptoms; Hot Flashes","Androgen Deprivation Therapy","Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma","Androgen-deprivation Therapy","Hot Flashes","Hot Flushes","Hot Flushes and\u002For Sweats",[183,186,187,26,179],"2026-03-05",{"date":192,"type":41},"2026-03-09",{"date":194,"type":41},"2026-01-14",{"date":196,"type":20},"2028-12-31",{"name":198,"class":48},"Shehzad Basaria, M.D.",{"id":200,"slug":201,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":206,"targetDuration":4,"studyType":107,"phases":4,"briefSummary":208,"conditions":209,"keywords":213,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":138},"100603087","immune-biomarkers-in-prostate-cancer-patients-treated-with-brachytherapy-100603087","NCT07131956","Immune Biomarkers in Prostate Cancer Patients Treated With Brachytherapy","Immune Biomarkers in Prostate Cancer Patients Treated With Brachytherapy (ImmunBioProBrachy)","Inclusion Criteria Arm 1:\n\n* Primary treatment with I-125 seeds or HDR-BT\n* No previous treatment for prostate cancer\n* Age ≥ 18 years\n\nInclusion Criteria Arm 2:\n\n* HDR- or PDR-BT\n* No radiation therapy within three months before salvage treatment\n* Complete documentation available on previous treatment for prostate cancer\n* No history of prostatectomy\n* Age ≥ 18 years\n\nExclusion Criteria:\n\n* Pre-existent auto-immune disease\n* patients under bloodthinning medication\n* substance abuse",{"count":207,"type":20},200,"Analysis of peripheral immune cells before, during, and after brachytherapy treatment. Corresponding analysis of tissue samples collected during brachytherapy treatment.",[210,211,212,29],"Prostate Cancer (Diagnosis)","Prostate Cancer Patients Who Have Brachytherapy Seed Implant","Prostate Cancer Patients Treated by Radiotherapy",[214,215,216],"Immune-profiling in prostate cancer patients","brachytherapy for prostate cancer","interstitial brachytherapy for prostate cancer","2025-11-17",{"date":219,"type":41},"2025-11-18",{"date":221,"type":20},"2025-12",{"date":223,"type":20},"2028-07-31",{"name":225,"class":48},"University of Erlangen-Nürnberg Medical School",{"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":237,"conditions":238,"keywords":239,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":250},"100587018","phase-3-a-multicenter-open-label-prospective-phase-iii-clinical-trial-to-evaluate-inr101-injection-for-petct-imaging-in-participants-with-suspected-recurrent-prostate-cancer-after-radical-treatment-100587018","NCT06922929","A Multicenter, Open-label, Prospective Phase III Clinical Trial to Evaluate INR101 Injection for PET\u002FCT Imaging in Participants With Suspected Recurrent Prostate Cancer After Radical Treatment","A Multicenter, Open-label, Prospective Phase III Clinical Trial to Evaluate the Diagnostic Efficacy and Safety of INR101 Injection for PET\u002FCT Imaging in Participants With Suspected Recurrent Prostate Cancer After Radical Treatment","Inclusion Criteria:\n\n1. Males aged ≥18 years old\n2. ECOG score of 0 or 1\n3. Participants confirmed as prostate adenocarcinoma by histological pathological diagnosis, and have an elevated PSA level and are suspected of recurrence after previously receiving radical prostatectomy and\u002For radical radiotherapy (the PSA level is ≥ 0.2 ng\u002FmL in two consecutive tests after 6 weeks following radical prostatectomy; or the PSA level is increased by ≥ 2 ng\u002FmL compared to the lowest value after radical radiotherapy).\n4. Routine blood tests, liver and kidney function meet the corresponding conditions:\n\n   * Hemoglobin \\> 80 g\u002FL; Platelet count \\> 50×10⁹\u002FL\n   * AST, ALT≤ 5 x ULN\n   * Total bilirubin≤ 3 x ULN\n5. Life expectancy of at least 6 months as assessed by investigator\n6. Agree to use contraceptive measures from the date of signing the informed consent form to 3 months after medication administration, and avoid sperm donation\n7. The participant\u002Flegal authorized representative understands the purpose and procedures of the trial and signs the informed consent form\n\nExclusion Criteria:\n\n1. Participants who are unable to complete the imaging as required\n2. Having had ≥ 2 types of malignant tumors within 5 years prior to the first administration, with the exception of fully treated non-metastatic thyroid cancer, basal cell carcinoma of the skin, superficial squamous cell carcinoma of the skin, and superficial bladder cancer.\n3. Participants in other interventional clinical trials and within 5 half-lives of the investigational medicinal product or participants in other interventional clinical trials before signing the informed consent form; or participants in clinical trials of radioactive therapeutic drugs before signing the informed consent form and the time from the drug withdrawal to the signing date of the informed consent form is less than 3 months.\n4. Have received intravenous iodine contrast agent within 24 hours prior to the administration of INR101, or have received any high-density oral contrast agent within 5 days (except for those who, as judged by the investigator, have no residual contrast agent in the intestines; oral water-soluble contrast agents are acceptable).\n5. Participants with a history of salivary gland diseases or Paget's disease; participants with a history of fracture within the past year\n6. Participants with hip joint prostheses\n7. Known allergy to the active ingredients of INR101 or its components\n8. Investigators judge that there are any medical diseases or other conditions that may affect safety, compliance or may affect the study results.",{"count":234,"type":20},110,[236],"PHASE3","A multicenter, open-label, prospective Phase III clinical trial to evaluate INR101 injection for PET\u002FCT imaging in participants with suspected recurrent prostate cancer after radical treatment.",[29],[240],"suspected recurrent prostate cancer","2025-04-09",{"date":243,"type":41},"2025-04-11",{"date":245,"type":20},"2025-04",{"date":247,"type":20},"2027-04",{"name":249,"class":48},"Yunhe Pharmaceutical (Tianjin) Co., Ltd",32,{"id":252,"slug":253,"hasResults":11,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":257,"eligibilityCriteria":258,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":259,"targetDuration":4,"studyType":21,"phases":261,"briefSummary":262,"conditions":263,"keywords":268,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":49},"100466318","phase-3-metastasis-directed-therapy-for-oligorecurrent-prostate-cancer-100466318","NCT05352178","Metastasis-directed Therapy for Oligorecurrent Prostate Cancer","a New Spark in Treating Oligorecurrent Prostate Cancer: Adding Systemic Treatment to Stereotactic Body Radiotherapy or Metastasectomy: Key to Long-lasting Event-free Survival?","SPARKLE","Inclusion Criteria:\n\n* Histologically proven initial diagnosis of prostate adenocarcinoma\n* Priory treated and controlled primary tumor\n* Biochemical recurrence defined by prostate-specific antigen (PSA) values \\>0,2 ng\u002Fml (i.e., two consecutive increases) following radical prostatectomy + postoperative radiotherapy and a PSA value of 2 ng\u002Fml above the nadir after high-dose RT.\n* Oligorecurrent disease defined as a maximum of 5 extracranial metastases in any organ, diagnosed on PSMA PET-CT or PSMA PET-MRI reported according to the E-PSMA consensus guidelines for interpretation of PSMA-PET (26). Nodal (N1) disease can be included only when accompanied by M1a-c disease, provided that the total number of spots does not exceed 5.\n* Serum testosterone level within normal range.\n* WHO performance 0-2\n* Age \\>= 18 years old\n* Absence of psychological, sociological or geographical condition potentially hampering compliance with study protocol.\n* Patients must be presented at the multidisciplinary board meeting and the inclusion in the trial needs approval by this board.\n* Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures\n* 2\\. Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner.\n\nExclusion Criteria:\n\n* Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol\n* Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial\n* Participation in an interventional Trial with an investigational medicinal product (IMP) or device\n* Serum testosterone level at castration level.\n* PSA rise while on active treatment (LHRH-agonist, LHRH antagonist, anti-androgen, maximal androgen blockade, oestrogen)\n* Presence of poly-metastatic disease, defined as more than 5 metastatic lesions.\n* Active malignancy other than prostate cancer that could potentially interfere with the interpretation of this trial.\n* Previous treatments (RT, surgery) or comorbidities rendering new treatment with SBRT impossible.\n* Contra indications for intake of enzalutamide (seizure or any condition that may predispose to seizure; significant cardiovascular disease within the last three months including myocardial infarction, unstable angina, congestive heart failure, ongoing arrythmias of grade \\> 2 or a thromboembolic event).\n* Not able to understand the treatment protocol or sign informed consent.",{"count":260,"type":20},873,[236],"The aim is to investigate whether the addition of short-term androgen deprivation therapy (ADT) during 1 month or short-term ADT during 6 months together with an androgen receptor targeted therapy (ARTA) to metastasis-directed therapy (MDT) significantly prolongs poly-metastatic free survival (PMFS) and\u002For metastatic castration-refractory prostate cancer free survival (mCRPC-FS) in patients with oligorecurrent hormone sensitive prostate cancer.",[26,29,30,264,265,266,267],"Metastatic Cancer","Oligometastatic Disease","Oligometastasis","Hormone Sensitive Prostate Cancer",[269,270,271,272],"Androgen deprivation therapy","Androgen receptor targeted agent","Stereotactic body radiation therapy","Metastasis-directed therapy","2024-07-01",{"date":275,"type":41},"2024-07-03",{"date":277,"type":41},"2022-04-20",{"date":279,"type":20},"2032-04-25",{"name":281,"class":48},"Universitaire Ziekenhuizen KU Leuven",{"id":283,"slug":284,"hasResults":11,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":288,"eligibilityCriteria":289,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":290,"targetDuration":4,"studyType":21,"phases":292,"briefSummary":293,"conditions":294,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":295,"lastUpdatePostDateStruct":296,"startDateStruct":298,"completionDateStruct":300,"leadSponsor":302,"locationsCount":49},"100488933","phase-1-antibody-cc-1-in-men-with-biochemical-recurrence-of-prostate-cancer-100488933","NCT05646550","Antibody CC-1 in Men With Biochemical Recurrence of Prostate Cancer","Phase I Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of the Bispecific Antibody CC-1 in Men With Biochemical Recurrence of Prostate Cancer","ProSperACC-1","Inclusion Criteria:\n\n* Written informed consent\n* Patient is able to understand and comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations\n* Men aged 18 and above\n* Earlier histologic diagnosis of prostatic adenocarcinoma\n* Low risk of rapid disease progression, defined as:\n\n  \\- PSA-detection Time (DT) \\> 1 year AND pathological International Society of Urological Pathology (ISUP) grade \\\u003C 4 for men with prior radical prostatectomy or Interval to biochemical recurrence \\> 18 months and biopsy ISUP grade \\\u003C 4 for men with prior radiation therapy\n* Biochemical recurrence (BCR) in compliance with the following 3 conditions:\n\n  * after having finished last definitive treatment\n  * PSA ≥0.2 ng\u002FmL or PSA \\> nadir + 2 ng\u002FmL (after definitive RT), with two increasing PSA values prior to study treatment\n  * no distant metastasis upon PSMA- positron emission tomography (PET) imaging\n* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1\n* Male patients with partners of child-bearing potential, who are sexually active, must agree to the use of one highly effective form of contraception and one barrier method. This should be started from the signing of the informed consent and continue throughout period of taking study treatment and for 4 months after the last dose of study drug\n* Adequate bone marrow, renal, and hepatic function defined by laboratory tests within 21 days prior to study treatment:\n\n  * Hemoglobin ≥ 9 g\u002Fdl (Transfusion of packed red blood cells prior to enrolment allowed)\n  * Neutrophil count ≥ 1,500\u002Fmm3\n  * Platelet count ≥ 100,000\u002Fµl\n  * Bilirubin ≤ 1.5 x upper limit of normal (ULN)\n  * alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN\n  * gamma-glutamyl-transferase (γ-GT) ≤ 2.5 x ULN\n  * prothrombin time (PT) - international normalised ratio (INR) \u002F partial thromboplastin time (PTT) ≤ 1.5 x ULN\n  * Creatine kinase ≤ 2.5 x ULN\n  * Serum creatinine ≤ 1.5 mg\u002Fdl or creatinine clearance ≥ 60 ml\u002Fmin\n\nExclusion Criteria:\n\n* PSA \\>5 ng\u002Fml.\n* For men with prior radical prostatectomy:\n\n  * PSA-DT \\\u003C 1 year or\n  * pathological ISUP grade 4-5\n* For men with prior radiation therapy:\n\n  * Interval to biochemical recurrence \\\u003C 18 months or\n  * biopsy ISUP grade 4-5\n* Other malignancy within the last 2 years except: adequately treated non-melanoma skin cancer and low-grade non-muscle invasive papillary bladder cancer.\n* Concurrent or previous treatment within 30 days in another interventional clinical trial with an investigational anticancer therapy\n* Patients who are receiving androgen-deprivation therapy.\n* Patients who have received prior Androgen Deprivation Therapy (ADT) are not eligible with the exception of those that received ADT ≤ 36 months in duration and ≥9 months before enrolment and administered only in the neoadjuvant\u002Fadjuvant setting.\n* Castrate level of serum testosterone \\\u003C50 ng\u002FdL at screening.\n* History of HIV infection\n* Viral active or chronic hepatitis (HBV or HCV)\n* Ongoing autoimmune disease\n* Current relevant central nervous system pathology (e.g. seizure, paresis, aphasia, cerebrovascular ischemia\u002Fhemorrhage, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder)\n* Therapeutic anticoagulation\n* Non-controlled hypertension, defined as mean blood pressure values in 24-hours blood pressure measurement of \\>130 mmHg or \\>90 mmHg for systolic or diastolic, respectively\n* Heart failure defined as New York Heart Association (NYHA) III\u002FIV\n* Severe obstructive or restrictive ventilation disorder\n* Known intolerance to CC-1 or other immunoglobulin drug products as well as hypersensitivity to any of the excipients present in CC-1",{"count":291,"type":20},56,[84],"This trial is a phase I open-label, single center study designed to evaluate the safety, tolerability and preliminary efficacy of the bispecific prostate specific membrane antigen (PSMA) and cluster of differentiation protein 3 (CD3) antibody CC-1 in men with biochemical recurrence (BCR) of prostate cancer (PC). The PSMA binder in CC-1 reacts with tumor cells and also binds to tumor vessels, thereby allowing for a dual mode of anti-cancer action. CC-1 was developed in a novel format, which not only prolongs serum half-life, but most importantly reduces off-target T-cell activation with accordingly reduced side effects. The study entails a part I (dose escalation part) to identify the maximally tolerated dose of CC-1, which then will be further evaluated in part II of the study (dose expansion part). After application of two low doses as safety steps in the first cycle, CC-1 will be applied twice weekly for three consecutive weeks within 4 week cycles as a short-term intravenous infusion (3 hours). The planned trial ultimately shall define the recommended phase II dose (RP2D) of CC-1 in the disease setting of BCR of PC.",[29],"2024-05-14",{"date":297,"type":41},"2024-05-16",{"date":299,"type":41},"2022-11-11",{"date":301,"type":20},"2026-12",{"name":303,"class":48},"University Hospital Tuebingen",{"id":305,"slug":306,"hasResults":11,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":4,"eligibilityCriteria":310,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":311,"enrollmentInfo":312,"targetDuration":4,"studyType":21,"phases":313,"briefSummary":314,"conditions":315,"keywords":316,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":49},"100533005","phase-2-psma-rlt-in-biochemically-recurrent-pca-100533005","NCT06220188","PSMA-RLT in Biochemically Recurrent PCa","[177Lu]Lu-PSMAI&T Radioligand Therapy (PSMA-RLT) for Patients With Prostate Cancer and Biochemical But Not Radio-morphological Local Recurrence After Primary Therapy With Curative Intent: A Prospective Phase II Pilot Study","Inclusion Criteria:\n\n* Patients with biochemical recurrence after radical prostatectomy and radiotherapy with a PSA doubling-time (DT) of ≤ 12 months.\n* No hormonal therapy within the last 12 months or recovered testosterone levels.\n* PSMA PET negative result for local recurrence; presence of distant metastases is allowed: (cN0, cM0\u002FcM1).\n* Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1\n* Patients must have adequate bone marrow reserve: WBC ≥1.5 x 109 \u002FL, Platelets ≥100 x 109 \u002FL and Haemoglobin ≥9 g\u002FdL.\n* Patients must have adequate renal function with eGFR ≥ 50mL\u002Fmin\u002F1.73m2 using the Modification of Diet Renal Disease (MDRD) equation and an Albumin level of ≥2.5 g\u002FdL.\n* Patients must be able to sign Informed Consent Form.\n\nExclusion Criteria:\n\n* Concomitant participation in any other interventional trial.\n* Concurrent severe oncological and medical conditions that result in patients not having a life expectancy of longer than one year.\n* Presence of clinically relevant somatic or psychiatric diseases that might interfere with the objectives and assessments of the study.\n* Complete urinary out-flow obstruction or severe unmanageable urinary incontinence.","80 Years",{"count":19,"type":20},[23],"Prospective single-center one-arm phase II study in patients with prostate cancer and confirmed biochemical recurrence (BCR) with PSA of ≥ 0.2 ng\u002Fml after radical prostatectomy (RP) or PSA \\> nadir + 2ng\u002Fml after radiotherapy (RT) but not radio-morphological local recurrence after primary therapy with curative intent receive systemic therapy with only 2 cycles of highly standardized (3 GBq in first cycle and 6 GBq in the second cycle) PSMA-RLT at 6-week intervals.",[29],[317,318,319,32,320],"[177Lu]Lu-PSMA I&T","PSMA-radioligand therapy","Biochemical recurrence","PSA value","2024-02-10",{"date":323,"type":41},"2024-02-13",{"date":325,"type":41},"2024-01-15",{"date":327,"type":20},"2027-01",{"name":329,"class":48},"Medical University of Vienna",{"id":331,"slug":332,"hasResults":11,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":336,"eligibilityCriteria":337,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":338,"targetDuration":4,"studyType":107,"phases":4,"briefSummary":340,"conditions":341,"keywords":343,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":352,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":49},"100441022","psma-guided-approach-for-biochemical-relapse-after-prostatectomy-psiche-100441022","NCT05022914","PSMA Guided Approach for bIoCHEmical Relapse After Prostatectomy-PSICHE","Prostate-Specific Membrane Antigen (PSMA) Guided Approach for bIoCHEmical Relapse After Prostatectomy- A Prospective Observational Study-PSICHE","PSICHE","Inclusion Criteria:\n\n* Signed informed consent\n* Age \\>18\n* Patient suitable for 68Ga-PSMA PET\u002FCT re-staging according to clinical practice (Previous radical prostatectomy with histological result of Prostate adenocarcinoma +\u002F- postoperative prostate bed radiotherapy (adjuvant or salvage setting), with a biochemical relapse defined as a PSA \\> 0.2 and \\\u003C1\n\nExclusion Criteria:\n\n* ADT administration within 6 months from study enrollment\n* Persistent elevation of PSA after RP measured within 16 weeks from surgery (\\> 0.1 ng\u002Fml)",{"count":339,"type":20},180,"This observational study was designed to evaluate progression free survival after PSMA-PET\u002FCT based salvage approach for patients affected by biochemical relapse after radical prostatectomy.",[26,342,176,29],"Biochemical Relapse Fo Malignant Neoplasm of Prostate",[344,345,346,347,348,349,350],"PSMA","68Ga-PSMA PET\u002FCT","PET\u002FCT","Biochemical Relapse","micro-RNA","SBRT","Radiotherapy","2021-08-24",{"date":353,"type":41},"2021-08-26",{"date":355,"type":41},"2021-01-19",{"date":357,"type":20},"2027-01-19",{"name":359,"class":48},"Azienda Ospedaliero-Universitaria Careggi"]