[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"oligometastatic-prostate-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:oligometastatic-prostate-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,47,77,102,124,155,177],{"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":46},"100409352","550020-vs-sabr-or-brachytherapy-for-primary-oligometastatic-prostate-cancer-treatment-prompt-100409352",false,"NCT04610372","5500\u002F20 vs. SABR or Brachytherapy for PRimary OligoMetastatic Prostate Cancer Treatment (PROMPT)","Moderate Versus Ultra Hypofractionation or Brachytherapy for PRimary OligoMetastatic Prostate Cancer Treatment","PROMPT","Inclusion Criteria:\n\n* Signed study specific informed consent\n* European Cooperative Oncology Group performance status 0 to 2\n* Histologically confirmed adenocarcinoma of the prostate\n* Any Tumor stage, any T, any N, M1\n* No prior therapy for prostate cancer apart from androgen deprivation\n* Planned for long-term androgen deprivation therapy (greater than 9 months in duration)\n* Patient is able and willing to complete the quality of life questionnaires, and other assessments that are a part of this study\n* For brachytherapy arms, patient must be technically suitable for brachytherapy according to investigator, in terms of bladder function and prostate size.\n\nExclusion Criteria:\n\n* High metastatic burden defined as 5 or more bone metastases or visceral metastases\n* Contraindications to EBRT such as active inflammatory bowel disease or previous pelvic radiation\n* For Brachytherapy Arms =: Any prior Transurethral resection of prostate","MALE","18 Years",{"count":20,"type":21},168,"ESTIMATED","INTERVENTIONAL",[24],"NA","We will investigate whether ultrahypofractionation using stereotactic ablative radiotherapy (SABR) or brachytherapy is as well-tolerated as moderately hypofractionated external beam radiotherapy (EBRT) for treating the prostate in patients with oligometastatic prostate cancer. Secondary aims include assessment of progression-free survival (PFS) and overall survival (OS) as well as cost-effectiveness. We hypothesize that ultrahypofractionation will maintain favorable toxicity profiles and quality of life while achieving comparable or better efficacy, thereby providing a convenient and cost-effective alternative to moderately hypofractionated EBRT.",[27],"Oligometastatic Prostate Cancer",[29,30,31,32,33],"prostate adenocarcinoma","oligometastases","radiotherapy","hypofractionation","brachytherapy","RECRUITING","2026-04-30",{"date":37,"type":38},"2026-05-06","ACTUAL",{"date":40,"type":38},"2021-07-12",{"date":42,"type":21},"2033-06-30",{"name":44,"class":45},"British Columbia Cancer Agency","OTHER",4,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":61,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"100630633","phase-2-rezvilutamide-with-radical-prostatectomy-and-metastasis-directed-therapy-in-oligometastatic-prostate-cancer-100630633","NCT07490210","Rezvilutamide With Radical Prostatectomy and Metastasis-Directed Therapy in Oligometastatic Prostate Cancer","Rezvilutamide Combined With Radical Prostatectomy and Metastasis-Directed Radiotherapy in Oligometastatic Prostate Cancer Patients: A Multicenter, Three-Arm, Open-Label, Randomized Controlled Phase II Clinical Trial","OMPC-RPM","Inclusion Criteria:\n\n1. Voluntary participation with signed informed consent and understanding of study procedures.\n2. Age ≥18 years.\n3. Histologically or cytologically confirmed prostatic adenocarcinoma without neuroendocrine differentiation, small cell, sarcomatoid, spindle cell, or signet ring cell histology.\n4. Metastatic hormone-sensitive prostate cancer (mHSPC) with oligometastatic disease defined as: a) ≤10 metastatic lesions combined (bone lesions on Tc-99m bone scan plus extra-pelvic lymph nodes on CT\u002FMRI); and b) No visceral metastases on CT\u002FMRI.\n5. Planned or ongoing androgen deprivation therapy (ADT) with LHRH agonist\u002Fantagonist (medical castration) or prior bilateral orchiectomy (surgical castration) within ≤4 weeks before enrollment.\n6. Adequate organ function (without transfusion or hematopoietic growth factor support within 2 weeks prior to screening labs):\n\n   * Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL\n   * Platelet count (PLT) ≥100×10⁹\u002FL\n   * Hemoglobin (Hb) ≥90 g\u002FL\n   * Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance \\>50 mL\u002Fmin\n   * Total bilirubin (BIL) ≤1.5×ULN\n   * AST\u002FSGOT or ALT\u002FSGPT ≤2.5×ULN\n   * International normalized ratio (INR) ≤1.5, PT and APTT ≤1.5×ULN\n   * Left ventricular ejection fraction (LVEF) ≥50%\n7. Male patients with female partners of childbearing potential must agree to use effective contraception during the study and for 3 months after the last dose, and must not donate sperm during this period.\n8. Ability to comply with the study protocol as judged by the investigator.\n9. Ability to adhere to scheduled visits, treatment plans, and laboratory assessments.\n\nExclusion Criteria:\n\n1. Prior radical prostatectomy, pelvic radiotherapy, prostatic ablation, or any systemic anti-prostate cancer therapy (including novel hormonal therapy, chemotherapy, radionuclide therapy, cancer vaccines, or immune checkpoint inhibitors), except ADT initiated ≤4 weeks prior to randomization that meets inclusion criteria.\n2. Prior radiotherapy to prostate cancer metastases.\n3. Known visceral metastases (liver, lung, brain, peritoneum, etc.) or diffuse bone marrow metastases.\n4. Severe contraindications to surgery or radiotherapy, including major cardiovascular disease (e.g., NYHA Class III-IV heart failure, recent myocardial infarction), pulmonary insufficiency unable to tolerate anesthesia, severe bleeding tendency, or bone marrow suppression.\n5. Other prior or concurrent malignancies, unless basal cell carcinoma of the skin or other cancers cured for \\>5 years.\n6. Active infections, including active hepatitis B (HBV DNA \\>2×10³ IU\u002FmL), hepatitis C RNA positive with hepatic impairment, HIV infection, or inadequately treated syphilis.\n7. Uncontrolled major cardiovascular disease within 6 months prior to screening, including: a) unstable angina or recent myocardial infarction (within 6 months); b) clinically significant arrhythmias (e.g., sustained ventricular tachycardia); c) heart failure (NYHA Class ≥III).\n8. Severe hepatic or renal dysfunction or other laboratory abnormalities not meeting the organ function requirements specified in Inclusion Criterion #6.\n9. Known hypersensitivity or history of severe adverse reactions to study medications (novel hormonal agents), anesthetics, or contrast agents used in the study.\n10. Any medical, psychological, or social factors that may affect patient compliance or interfere with study outcome assessment, including psychiatric disorders, substance abuse, or other conditions deemed unsuitable by the investigator.\n11. Concurrent participation in another interventional clinical study, or use of any investigational drug or medical device within 4 weeks prior to randomization.\n12. Any other condition that the investigator considers unsuitable for study participation.\n\n    \\-",{"count":56,"type":21},300,[58],"PHASE2","Prostate cancer represents the second most common malignancy in men worldwide. Oligometastatic prostate cancer (OMPC), defined as a transitional state between localized and widespread metastatic disease (≤10 metastatic lesions without visceral metastases), exhibits relatively indolent biological behavior, offering a window for curative-intent multimodal therapy. While standard systemic therapy with androgen deprivation therapy (ADT) plus novel hormonal agents (NHA) remains the backbone for metastatic hormone-sensitive prostate cancer (mHSPC), emerging evidence suggests that maximal cytoreductive therapy-combining systemic treatment with local interventions (Radical prostatectomy（RP） and Metastasis-directed radiotherapy（MDT）)-may improve survival outcomes. Rezvilutamide (SHR3680), a novel androgen receptor inhibitor independently developed by a Chinese pharmaceutical company, has demonstrated superior radiographic progression-free survival (rPFS) and overall survival (OS) compared to bicalutamide in high-volume mHSPC (CHART study). However, the value of adding metastasis-directed radiotherapy (MDRT) to rezvilutamide and radical prostatectomy in OMPC remains unproven. This trial hypothesizes that maximal cytoreductive therapy (systemic therapy + surgery + MDRT) will significantly prolong progression-free survival (PFS) compared to systemic therapy alone.\n\nThis is a multicenter, three-arm, open-label, randomized controlled phase II clinical trial (Protocol No.: MA-PCa-II-023; Lead Investigator: Prof. Bo Dai, Fudan University Shanghai Cancer Center). The study will enroll 300 patients randomized in a 2:2:1 ratio to:\n\nArm A (Experimental): Rezvilutamide (240 mg QD) + ADT → radical prostatectomy at month 3 (if PSA decline ≥50%, castrate testosterone level, and resectable disease) → MDT (SBRT 30-40 Gy\u002F3-5 fractions) to all evaluable metastases at month 6 （ 3 month post-surgery）\n\nArm B (Control): Rezvilutamide (240 mg QD) + ADT alone\n\nArm C (Factorial): Rezvilutamide (240 mg QD) + ADT → radical prostatectomy at month 3 (without MDT)\n\nEligible patients are males ≥18 years with histologically confirmed prostate adenocarcinoma (no neuroendocrine differentiation), newly diagnosed mHSPC with oligometastatic disease (≤10 bone\u002Flymph node metastases on conventional imaging; no visceral metastases), and planned ADT. Key exclusion criteria include prior radical prostatectomy, pelvic radiotherapy, systemic therapy for prostate cancer (except ≤4 weeks of ADT), or contraindications to surgery\u002Fradiotherapy.\n\nThe primary endpoint is PFS, defined as time from randomization to first biochemical progression (PSA rise ≥25% and ≥1 ng\u002FmL above nadir confirmed after ≥3 weeks), radiographic progression (RECIST 1.1\u002FPCWG4), clinical progression (new symptoms from local\u002Fmetastatic disease), or death. Secondary endpoints include rPFS, OS, PSA response rates (PSA50\u002FPSA90), local therapy completion rate, time to CRPC, quality of life (FACT-P and EPIC-26 questionnaires), and safety profiles. Exploratory endpoints evaluate the role of baseline PSMA PET\u002FCT in staging and the development of artificial intelligence models using multimodal data (clinical, imaging, pathology, molecular) to predict prognosis.",[27],[62,63,64,65],"OMPC","MDRT","Rezvilutamide","Radical Prostatectomy","NOT_YET_RECRUITING","2026-03-19",{"date":69,"type":38},"2026-03-24",{"date":71,"type":21},"2026-05-01",{"date":73,"type":21},"2032-05-31",{"name":75,"class":45},"Fudan University",1,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":88,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":101},"100594107","comprehensive-versus-primary-tumor-radiotherapy-in-oligometastatic-prostate-cancer-100594107","NCT07015138","Comprehensive Versus Primary Tumor Radiotherapy in Oligometastatic Prostate Cancer","A Multicenter, Randomized Controlled Clinical Trial Comparing Comprehensive Radiotherapy Versus Primary Tumor Radiotherapy in Oligometastatic Prostate Cancer","PROLONG-3","Inclusion Criteria:\n\n* Male patients aged 18-85 years.\n* Histopathologically confirmed acinar adenocarcinoma of the prostate. The presence of a minor component of ductal adenocarcinoma, intraductal carcinoma, and\u002For neuroendocrine differentiation is permitted.\n* PSMA PET performed within 4 weeks prior to the start of study drug therapy or up to 4 weeks after initiation, demonstrating the presence of 1 to 10 metastatic lesions.Metastasis within pelvic lymph nodes (N1 disease) is permitted but not counted towards the total number of metastatic lesions. Metastasis to non-regional lymph nodes is permitted and counted towards the total number.The pelvis is anatomically divided into 4 regions: left hemipelvis (ilium\u002Fischium\u002Fpubis), right hemipelvis (ilium\u002Fischium\u002Fpubis), sacrum, and coccyx. Multiple lesions within a single anatomical division are aggregated and counted as one metastatic lesion.\n* Prior androgen deprivation therapy (ADT) is permitted if the total duration was ≤ 12 months before enrollment. ADT includes luteinizing hormone-releasing hormone (LHRH) agonists or antagonists and novel hormonal agents (e.g., abiraterone, enzalutamide, apalutamide, darolutamide).\n* Eastern Cooperative Oncology Group (ECOG) score 0-2.\n* Hematology: Neutrophil count \\>=1.0×10\\^9\u002FL; Platelet count \\>=75×10\\^9\u002FL; Hemoglobin \\>=90 g\u002FL.\n\nExclusion Criteria:\n\n* Small cell carcinoma of the prostate or prostate sarcoma.\n* The primary focus has received external radiation therapy, brachytherapy, and radical prostatectomy.\n* Received non-endocrine systemic therapies prior to enrollment (e.g., chemotherapy, targeted therapy, radionuclide therapy).\n* Metastatic castration-resistant prostate cancer (mCRPC) phase (EAU Guidelines\\*).\n* Presence of visceral metastases (e.g., liver, lung).\n* Previous bilateral orchiectomy.\n* Comorbidities: Severe comorbidities affecting survival or treatment tolerance, including: Cardiovascular diseases (NYHA Class III\u002FIV heart failure, uncontrolled arrhythmias); Renal insufficiency (eGFR \\\u003C30 mL\u002Fmin\u002F1.73m\\^2); Neuropsychiatric disorders impairing protocol compliance.\n\n  * Definition of mCRPC (EAU Guidelines):\n\nMetastatic castration-resistant prostate cancer (mCRPC) is defined as disease progression despite serum testosterone levels below 50 ng\u002FdL (or 1.7 nmol\u002FL), concurrently with one or more of the following:\n\n1. PSA progression: A sequence of at least three consecutive rises in PSA, measured ≥1 week apart, resulting in a ≥50% increase from the nadir (lowest) level, with a minimum absolute PSA value \\>2 ng\u002FmL.\n2. Radiographic progression: The appearance of new lesions, defined as either:\n\n   * ≥2 new lesions on bone scan (Tc-99m bone scintigraphy), or\n   * New measurable soft tissue lesions according to RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 criteria.\n3. Unequivocal clinical progression: Clinical progression in the absence of concurrent PSA or radiographic progression should be viewed with suspicion and mandates further investigation to confirm disease progression.","85 Years",{"count":87,"type":21},390,[24],"This study is a multicenter, randomized controlled phase III clinical trial (PROLONG-3) designed to evaluate the survival benefit of comprehensive radiotherapy combined with primary tumor radiotherapy versus primary tumor radiotherapy alone in patients with newly diagnosed oligometastatic prostate cancer. The trial enrolled 390 patients with ≤10 metastatic lesions confirmed by PSMA PET imaging, who were randomized in a 2:1 ratio to either the intervention group (comprehensive radiotherapy + standard systemic therapy) or control group (primary radiotherapy + standard systemic therapy).\n\nStratification factors included Gleason score (GS ≤8 vs. GS 9-10) and number of metastases (1-3 vs. 4-10). The primary endpoint was 3-year progression-free survival (PFS), with secondary endpoints encompassing overall survival (OS), intermittent treatment rate, adverse events (CTCAE v5.0), and quality of life (EORTC QLQ questionnaires). To minimize bias, stratified block randomization and blinded endpoint adjudication were implemented, with treatment effects analyzed using Kaplan-Meier survival curves and Cox proportional hazards models.\n\nThe study's innovation lies in its definitive evaluation of the added value of comprehensive radiotherapy, combined with exploratory biomarker analyses (including genomic testing) to identify predictive markers of therapeutic response. Should the results demonstrate significant PFS improvement with comprehensive radiotherapy, this would provide high-level evidence to guide clinical practice, potentially influencing treatment guideline updates while optimizing patient quality of life and reducing healthcare burdens.",[91,27],"Prostate Cancer","2025-08-14",{"date":94,"type":38},"2025-08-20",{"date":96,"type":38},"2025-06-01",{"date":98,"type":21},"2027-12-31",{"name":100,"class":45},"Peking University First Hospital",3,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":22,"phases":112,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":101},"100482332","phase-2-lu-psma-for-oligometastatic-prostate-cancer-treated-with-stereotactic-ablative-radiotherapy-100482332","NCT05560659","Lu-PSMA for Oligometastatic Prostate Cancer Treated With STereotactic Ablative Radiotherapy","Lu-PSMA for Oligometastatic Prostate Cancer Treated With STereotactic Ablative Radiotherapy, a Randomised Phase II Parallel Cohort Trial","POPSTAR II","Inclusion Criteria:\n\n1. Male aged 18 years or older at screening\n2. Patient has provided written informed consent\n3. Histologically confirmed prostate adenocarcinoma w\n4. Prior definitive treatment of the primary with either curative intent radiotherapy and\u002For surgery\n5. Patient has 1-5 sites of nodal or bony metastases on 68Ga-PSMA or 18F-DCFPyL PET\u002FCT\n6. Adequate haematological function as defined by:\n\n   * Absolute neutrophil count (ANC) ≥1.5 x 109\u002FL\n   * Platelet count \\>150x 109\u002FL\n   * Haemoglobin ≥100 g\u002FL\n   * Creatinine Clearance ≥ 40mL\u002Fmin (Cockcroft-Gault formula)\n7. Assessed as suitable for SABR by a radiation oncologist\n8. Patients must agree to use an adequate method of contraception\n9. Have a performance status of 0-1 on the ECOG Performance Scale\n\nExclusion Criteria:\n\n1. Prior systemic therapy for metastatic prostate cancer. Prior ADT is allowed but ADT within 6 months of screening for the study is not allowed. If patients have received prior ADT, serum testosterone levels must be above the lower limit of normal\n2. Any visceral (AJCCC M1c) metastases\n3. Symptomatic cord compression, or clinical or imaging findings concerning for impending cord compression\n4. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator\n5. Has a known additional malignancy that is progressing or required active treatment in the last 2 years Note: Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer or carcinoma in situ such as breast cancer in situ that has undergone potentially curative therapy are not excluded.",{"count":111,"type":21},92,[58],"The aim of this study is to assess the progression free survival (PFS) of SABR alone and SABR + 177Lu-prostate-specific membrane antigen (PSMA) in patients with oligometastatic prostate cancer undergoing PSMA positron emission tomography (PET) staging.",[27],"2025-07-08",{"date":117,"type":38},"2025-07-11",{"date":119,"type":38},"2023-12-14",{"date":121,"type":21},"2027-05",{"name":123,"class":45},"Peter MacCallum Cancer Centre, Australia",{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":132,"enrollmentInfo":133,"targetDuration":4,"studyType":22,"phases":135,"briefSummary":136,"conditions":137,"keywords":138,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":76},"100509593","phase-2-adenosine-signaling-modulation-and-immune-checkpoint-inhibition-with-hormone-sensitive-oligometastatic-prostate-cancer-100509593","NCT05915442","Adenosine Signaling Modulation and Immune Checkpoint Inhibition With Hormone Sensitive Oligometastatic Prostate Cancer","Phase II Single Arm Study Testing SBRT, Adenosine Signaling Modulation (AB680, AB928), and Immune Checkpoint Inhibition (AB122) for Men With Hormone Sensitive Oligometastatic Prostate Cancer","SBRT-AMICO","Inclusion Criteria:\n\n1. Patient must have histologically confirmed adenocarcinoma of the prostate.\n2. Patient's primary prostate cancer tumor treated with surgery and\u002For radiation (+\u002F- ADT).\n3. Patients must have one to three asymptomatic metastatic tumors of the bone or soft tissue that developed in the preceding 6 months that are \\\u003C 5cm or \\\u003C 250 cm3.\n4. Prostate-specific antigen (PSA) \\> 0.5 ng\u002FmL but \\\u003C 50ng\u002Fml\n5. PSA doubling time (PSADT) \\\u003C 15 months (using all available PSA values from time of relapse)\n6. Testosterone \\> 125 ng\u002FmL\n7. Age ≥18 years.\n8. Patient must have life expectancy \\> 12 months.\n9. Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n10. Normal organ and marrow function as defined below:\n\n    * leukocytes ≥3,000\u002FmcL\n    * absolute neutrophil count ≥1,500\u002FmcL\n    * platelets ≥100,000\u002FmcL\n    * total bilirubin within normal institutional limits\n    * aspartate transaminase (AST)(serum glutamic-oxaloacetic transaminase (SGOT))\u002Falanine transaminase (ALT)(serum glutamic-pyruvic transaminase (SGPT) ) ≤2.5 × institutional upper limit of normal creatinine, within normal institutional limits\n11. Male participants with female partners of childbearing potential are required to use highly effective contraceptive measures which include condom use. A man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy. A female partner of is considered a woman of childbearing potential (WOCBP) following menarche and until becoming postmenopausal unless permanently sterile.\n\n    * Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.\n    * A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle-stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.\n\n    Highly effective contraceptive measures include:\n    * Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal\n    * Progestogen only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable\n    * Intrauterine device\n    * Intrauterine hormone-releasing system\n    * Surgical sterilization\n    * The male participant is vasectomized (with documented medical confirmation of surgical success) and is the sole sexual partner of the WOCBP participant\n    * Female partner of the male participant has undergone bilateral tubal ligation\n    * Complete sexual abstinence defined as refraining from heterosexual intercourse during the entire period of risk associated with study treatment. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant.\n12. Male participants should refrain from donating sperm for 180 days after the last dose of the study drugs.\n13. Patient must have the ability to understand and the willingness to sign written informed consent.\n\nExclusion Criteria:\n\n1. Patient may not have had prior systemic therapy, with the exception of androgen deprivation therapy (ADT) associated with treatment of the primary prostate tumor or with salvage radiation therapy. The ADT could not exceed 3-years in duration and must have occurred greater than 6 months before time of enrollment.\n2. Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.\n3. Spinal cord compression or impending spinal cord compression.\n4. Pulmonary and\u002For liver metastases \\> 1.0cm in largest dimension.\n5. History of malignancy other than prostate cancer within 2 years prior to screening, except for malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \\> 90%), such as nonmelanoma skin carcinoma or ductal carcinoma in situ.\n6. Use of other investigational agents or treatment protocol.\n7. Treatment with therapeutic oral or intravenous (IV) antibiotics within 2 weeks prior to initiation of study treatment with the exception of patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.\n8. Inability to swallow medications.\n9. Malabsorption condition that would alter the absorption of orally administered medications.\n10. Grade ≥ 3 hemorrhage or bleeding event within 28 days prior to initiation of study treatment.\n11. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan.\n12. Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia.\n13. Positive total hepatitis B core antibody (HBcAb) test at screening. Patients can be eligible if positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening. The HBV test will be performed only for participants who have a positive total HBcAb test. Due to safety concerns related to viral activation, development of a secondary malignancy, as well as the potential for increased treatment-related toxicity, eligible participants must not have evidence of chronic viral infection at screening.\n14. Due to the potential risk for drug-drug interactions with etrumadenant, participants must not have had:\n\n    1. Oral treatment with strong inhibitors of breast cancer resistance protein (BCRP) (e.g., cyclosporin A, eltrombopag) or BRCP substrates with a narrow therapeutic window, administered orally (e.g., prazosin, rosuvastatin) within 4 weeks or 5 drug-elimination half-lives of the drug (whichever is longer) prior to initiation of study treatment.\n    2. Oral treatment with strong inhibitors of P-glycoprotein (P-gp) substrates (e.g., itraconazole, quinidine, verapamil, dronedarone, ranolazine) or P-gp with a narrow therapeutic window, administered orally (e.g., digoxin) within 4 weeks or 5 drug-elimination half-lives of the drug (whichever is longer) prior to initiation of study treatment.\n    3. Treatment with known strong CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, phenobarbital, and St. John's Wort) or strong CYP3A4 inhibitors (e.g., clarithromycin, grapefruit juice, itraconazole, ketoconazole, posaconazole, telithromycin, and voriconazole) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment.\n    4. Treatment with known strong UDP-glucuronosyltransferases (UGTs) of UGT1A1, 1A4, 1A9 and 2B4 inhibitors (e.g., atazanavir) within 4 weeks or 5 half-lives of the drug, whichever is longer, prior to the initiation of study treatment.\n    5. Treatment with known sensitive substrates of BSEP within 4 weeks or 5 half-lives of the drug, whichever is longer, prior to the initiation of study treatment.\n    6. Treatment with known sensitive substrates of OCT2 within 4 weeks or 5 half-lives of the drug, whichever is longer, prior to the initiation of study treatment.\n    7. Treatment with known sensitive substrates of MATE1 within 4 weeks or 5 half-lives of the drug, whichever is longer, prior to the initiation of study treatment.\n15. Immunosuppression (e.g., solid organ transplant on immunosuppression).\n16. No known HIV, or active with Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV).\n17. Active autoimmune disease.\n18. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n19. Inability to lie flat to tolerate computed tomography (CT) simulation study and oligometastasis-directed stereotactic body radiotherapy (SBRT).\n20. Use of any live vaccines against infectious diseases within 28 days of first dose of investigational products.\n21. Refusal to sign informed consent.","99 Years",{"count":134,"type":21},23,[58],"This study will evaluate the safety and effectiveness of a combination of study drugs including zimberelimab, etrumadenant, and quemliclustat in combination with metastasis-directed irradiation in men with hormone sensitive oligometastatic prostate cancer.\n\nThe study aims to test the hypothesis that targeted inhibition of the adenosine signaling axis (quemliclustat (CD73 antagonist) + etrumadenant (A2AR\u002FA2BR antagonist)) and immune checkpoint inhibition (zimberelimab, α-PD-1) in combination with metastasis-directed stereotactic body radiation therapy (SBRT) will improve local control, progression-free survival (PFS), and hormone therapy-free survival and mitigate immunosuppressive changes to the tumor microenvironment (TME), compared to SBRT alone.",[27],[139,140,141,142,143,144,145],"Adenosine Signaling","AB680","AB928","AB122","Quemliclustatm","Etrumadenant","Zimberelimab","2025-05-15",{"date":148,"type":38},"2025-05-20",{"date":150,"type":38},"2023-07-01",{"date":152,"type":21},"2028-12",{"name":154,"class":45},"Catherine Spina",{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":162,"enrollmentInfo":163,"targetDuration":4,"studyType":22,"phases":165,"briefSummary":167,"conditions":168,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":76},"100590829","phase-2-maximal-tumor-eradication-for-oligometastatic-prostate-cancer-100590829","NCT06972511","Maximal Tumor Eradication for Oligometastatic Prostate Cancer","Apatamide Combined With Maximal Tumor Eradication for Oligometastatic Prostate Cancer, A Prospective Randomized Controlled Trial","Inclusion Criteria:\n\n* Age less than 75 years\n* EORTC QLQC-30 score 2\n* Life expectancy of 10 years\n* Patients with oligometastatic prostate cancer on clinicopathological assessment\n* Patients are suitable for radiotherapy and prostatectomy surgery\n* Patients agree to participate in the study and sign the informed consent form before enrollment\n\nExclusion Criteria:\n\n* Tumor related fracture\n* Cannot accept radiotherapy\n* Visceral metastasis\n* Serious infection\n* Thromboembolism history\n* Not effectively controlled cardiovascular complications","75 Years",{"count":164,"type":21},120,[58,166],"PHASE3","In China, the incidence of prostate cancer is increasing in recent years, and it has ranked 5th among common male tumors and 1st in urinary tumors. Unlike developed countries in Europe and the United States, in China, because prostate-specific antigen (PSA) screening has not been widely popularized, and early prostate cancer is mostly asymptomatic, about 13%-26% of prostate cancer patients have progressed to metastatic hormone-sensitive prostate cancer (mHSPC) at the time of initial diagnosis. Compared with localized prostate cancer, the 5-year survival rate of mHSPC is only 29.3%, which is prone to symptoms such as bone pain, pathological fracture, hematuria, and dysuria and seriously decrease the survival and quality of life. As a result, it is of great significance to carry out more refined management of mHSPC, explore more scientific treatment options, and delay the time to CRPC, which is of great significance for improving the prognosis and quality of life of patients and reducing medical burden. However, there is still no standard treatment strategy for OMPC patients which need more clinical exploration.\n\nTreatment of prostate primary in oligometastatic prostate cancer (OMPC) may improve survival and do not significantly increase complications. Radiotherapy showed excellent therapeutic effects on metastatic lesions, prolonged survival and without increasing significant adverse effects. In 2019, The New England Journal of Medicine reported a TITAN study that combining apatamide with ADT for metastatic hormone-sensitive prostate cancer, which significantly reduced the risk of death (82.4% VS 72.5%, P=0.005), and improved progression-free survival (68.2% VS 47.5, P \\\u003C0.001) without increasing adverse effects of treatment. In 2020, Johns Hopkins University published a phase I clinical study of radical treatment of 12 cases of OMPC. Patients were treated with neoadjuvant docetaxel chemotherapy or abiraterone, combined with radical prostatectomy for primary lesions, and stereotactic radiation for bone metastases to achieve the purpose of complete tumor eradication. Preliminary results showed that no additional complications were found except neutropenic fever in two cases. At the same time, the proportion of PSA maintained undetectable in 1,2,3 years was 12 \u002F 12 (100%), 10 \u002F 12 (83%) and 8 \u002F 12 (67%), respectively, showing good treatment results.\n\nSince 2014, the applicant has rich research experience in the treatment of oligometastatic prostate cancer and our results showed that systemic therapy combined with local tumor reduction therapy can confer a survival benefit for OMPC patients without a significant increase in complications. This clinical trial aimed to analyze the clinical efficacy and safety of maximal tumor eradication strategy for oligometastatic prostate cancer.",[27],"2025-05-13",{"date":146,"type":38},{"date":172,"type":38},"2023-08-20",{"date":174,"type":21},"2027-12-30",{"name":176,"class":45},"RenJi Hospital",{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":22,"phases":187,"briefSummary":188,"conditions":189,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":76},"100545833","phase-2-genomic-biomarker-guided-neoadjuvant-therapy-for-prostate-cancer-segno-100545833","NCT06387056","Genomic Biomarker-guided Neoadjuvant Therapy for Prostate Cancer (SEGNO)","An Exploratory Study of the Safety and Efficacy of Genomic Biomarker-guided Neoadjuvant Therapy for Locally Advanced and Oligometastatic Prostate Cancer (SEGNO)","SEGNO","Inclusion Criteria:\n\n* Males ≥ 18 years of age;\n* Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant must sign a consent form prior to enrolment in the trial to document their willingness to participate;\n* Imaging examination (defined by multiparametric magnetic resonance imaging, radionuclide bone scan and PSMA PET\u002FCT (prostate-specific membrane antigen positron emission tomography\u002Fcomputed tomography) confirmed locally advanced (identified as cT3b to cT4, N0 to N1, M0) and oligometastatic (identified as no visceral metastasis and ≤5 bone metastases) prostate cancer. Participants are considered tolerable to radical prostatectomy (RP) and pelvic lymph node dissection (PLND) after neoadjuvant therapy (NT). Participants must consent to RP and PLND after NT when defined as tolerable for RP and PLND at registration and prior to enrolment in the trial;\n* Histologically confirmed adenocarcinoma of the prostate without pathologic evidence of small cell and neuroendocrine differentiation at the time of initial diagnosis;\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 and a life expectancy of ≥ 3 years;\n* Participants must have adequate end-organ function to tolerate NT and subsequent RP+PLND and all laboratory tests must be performed within 4 weeks prior to registration into master protocol. Including the following indicators: hemoglobin (Hb) ≥85g\u002FL; White blood cell count (WBC) ≥3.0×109 \u002FL; Platelet (PLT) ≥ 75×109 \u002FL; Liver function: Total bilirubin (TBIL) ≤1.5×ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5× upper limit of normal value (ULN); Albumin (ALB) ≥25g\u002FL; Renal function: glomerular filtration rate (GFR) ≥ 60ml\u002Fmin;\n* Participants must consent to genetic testing at registration and prior to enrolment in the trial;\n* No prior systemic or localized treatment for prostate cancer. Up to 28 days of LHRHa, non-steroidal anti-androgen (NSAA) and novel hormone therapy (rezvilutamide) are allowable prior to treatment;\n* Participants must have the ability to swallow oral medication and follow the study procedure;\n* Participants must consent to use reliable contraceptive methods (such as condoms) and not to donate sperm throughout the study period and for 3 months after the last NT administration;\n* Participants must have no contraindications to any of the relevant drug treatments in the study.\n\nExclusion Criteria:\n\n* Participants with a history of hypersensitivity to any of the relevant drugs involved in this study;\n* Participants received more than 28 days of LHRHa, non-steroidal anti-androgen (NSAA) and novel hormone therapy (rezvilutamide) prior to registration, or enrolled in any other clinical studies for therapeutic purposes within 28 days prior to enrollment, or received any approved anticancer therapy within 28 days prior to enrollment;\n* Participants received local treatments of primary or metastatic lesions prior to enrollment;\n* Participants received bilateral orchiectomy prior to enrollment;\n* Hypogonadism or severe androgen deficiency as defined by screening serum testosterone more than 50 ng\u002FdL below the normal range for the institution;\n* Participants with a history of brain metastases or epilepsy;\n* Participants with severe cardiovascular disease, including: myocardial infarction or thrombosis in the previous 6 months; known unstable angina; history of documented congestive heart failure (New York Heart Association functional classification III-IV; QT interval \\> 480 ms; uncontrolled hypertension defined as resting systolic blood pressure \\> 170 mmHg or diastolic blood pressure \\> 105 mmHg;\n* Participants with clinically significant digestive tract abnormalities that may affect the process of drug intake, transport, or absorption (e.g. inability to swallow, chronic diarrhea, intestinal obstruction, etc., or total gastrectomy);\n* Participants with other clinically significant co-morbidities evaluated by the investigator, including uncontrolled lung disease, active central nervous system disease, active or uncontrolled bacterial, viral, or fungal infections requiring systemic treatment, or any other disease that may make the participant inappropriate for enrollment or RT + PLND after NT;\n* Participants with other known active cancers requiring treatment at the time of entry to the study, or had other malignancies within 5 years prior to enrollment;\n* Participants received surgeries other than diagnostic prostate biopsy within 4 weeks before enrollment;\n* Participants with active or known human immunodeficiency virus (HIV) with detectable viral load; active hepatitis B, defined as positive HBV DNA viral load or as defined by relevant guidelines; hepatitis C virus (HCV), except for those have been treated and have an undetectable viral load;\n* Participants with a history of non-compliance to medical regimen or inappropriate for the study, attributed to not meeting the principle of optimal benefit treatment.",{"count":186,"type":21},40,[58],"To evaluated the safety and efficacy of genomic biomarker-guided neoadjuvant therapy for locally advanced and oligometastatic prostate cancer.",[190,27],"Locally Advanced Prostate Cancer","2024-04-24",{"date":193,"type":38},"2024-04-26",{"date":195,"type":38},"2024-04-01",{"date":197,"type":21},"2029-04-01",{"name":199,"class":45},"The First Affiliated Hospital of Xiamen University"]