[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"biochemical-recurrence\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:biochemical-recurrence":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,45,74,104,124],{"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":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100539591","phase-2-salvage-radiotherapy-combined-with-androgen-deprivation-therapy-adt-with-or-without-rezvilutamide-in-the-treatment-of-biochemical-recurrence-after-radical-prostatectomy-for-prostate-cancer-100539591",false,"NCT06305832","Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer","Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer: a Prospective, Multicenter, Randomized Controlled Clinical Study","Inclusion Criteria:\n\n* 1\\. ≥40 years old, male;\n* 2\\. Postoperative pathology showed prostate adenocarcinoma;\n* 3\\. Postoperative pathological stage pN0 or pNx;\n* 4\\. PSA decline \\< 0.1ng\u002Fml within 8 weeks after radical prostate cancer surgery for at least 6 months\n* 5\\. Biochemical recurrence (PSA rose twice in a row, with an interval of ≥2 weeks and absolute value \\> 0.2ng\u002Fml), and traditional imaging (bone scan and CT\u002FMRI scan) did not show local recurrence and distant metastasis.\n* 6\\. Have one or more of the following risk factors:\n\n  * Postoperative CAPRA-S score ≥6 points;\n  * The pathological score of radical surgery for prostate cancer was Gleason 8-10;\n  * The highest postoperative biochemical recurrence PSA \\> 0.5ng\u002Fml;\n  * Postoperative pathological stage PT3\u002FT4;\n  * PSADT \\< 10 months;\n* 7\\. ECOG status is 0-1;\n* 8\\. Life expectancy greater than 10 years;\n* 9\\. Adequate hematological and organ function tests within 4 weeks prior to the first study treatment, as defined below:\n\n  * Neutrophil count (ANC)≥1.5×10\\^9\u002FL (no granulocyte colony-stimulating factor for 2 weeks prior to cycle 1, day 1);\n  * Platelet count (PLT)≥100×10\\^9\u002FL (no transfusion within 2 weeks prior to day 1 of cycle 1);\n  * Hemoglobin (Hb) ≥90g\u002FL\n  * Serum creatinine (Cr)≤1.5×ULN or creatinine clearance \\> 50ml\u002Fmin;\n  * Total bilirubin (BIL)≤1.5×ULN;\n  * Aspartate aminotransferase (AST\u002FSGOT) or alanine aminotransferase (ALT\u002FSGPT) level ≤2.5×ULN;\n  * International Standardized ratio (INR) ≤1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤1.5×ULN;\n  * Left ventricular ejection fraction (LVEF) ≥50%;\n* 10\\. The subject is willing and understands to sign the informed consent and is able to comply with the agreement.\n\nExclusion Criteria:\n\n* 1\\. Previously received endocrine therapy for prostate cancer (including but not limited to goserrelin, levoprorelin, digarek, bicalutamide, abiraterone acetate, darotamine, apatamide, enzalutamide, etc.) or pelvic radiotherapy;\n* 2\\. Postoperative biochemical recurrence, but PSA more than 2 ng\u002Fml;\n* 3\\. Postoperative pathology contains non-adenocarcinoma components, such as neuroendocrine differentiation or small cell features;\n* 4\\. Is currently participating in or has participated in an investigational drug study;\n* 5\\. Known or suspected allergy to reverumide and reverumide excipients;\n* 6\\. Inability to swallow, chronic diarrhea, intestinal obstruction, or other factors that affect drug use and absorption;\n* 7\\. Have a history of epilepsy, or a medical condition that can induce seizures within the 12 months prior to C1D1 (including a history of transient ischemic attacks, cerebral stroke, traumatic brain injury with disturbance of consciousness requiring hospitalization);\n* 8\\. Active heart disease in the 6 months prior to C1D1, including severe\u002Funstable angina, myocardial infarction, symptomatic congestive heart failure, and medically treatable ventricular arrhythmias;\n* 9\\. Have had any other malignancies within the 3 years prior to C1D1 (except for carcinoma in situ that has been in complete remission and malignancies that the investigator determined to be slowly progressing);\n* 10\\. Granulocyte colony-stimulating factor was used for support 2 weeks before C1D1;\n* 11\\. Blood transfusion within 2 weeks before C1D1;\n* 12\\. Active HBV and HCV infected persons (HBV copy number ≥10\\^4 copies \u002FmL, HCV copy number ≥10\\^3 copies \u002FmL);\n* 13\\. A history of immunodeficiency (including HIV positive, other acquired, congenital immunodeficiency diseases) or a history of organ transplantation;\n* 14\\. Male subjects whose partner is a fertile woman refuse surgical sterilization or use of effective contraception during the trial period and for 3 months after the last dose of riverutamide.\n* 15\\. The investigator determines subjects who may affect the conduct of clinical studies, who may not be able to comply with the protocol or cooperate with the protocol, and who pose research risks.","MALE","40 Years",{"count":19,"type":20},102,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","To evaluate the efficacy and safety of rezvilutamide in combination with androgen deprivation therapy(ADT) and standard salvage radiation therapy(SRT) or SRT combination with ADT in prostate cancer patients with biochemical recurrence of prostate-specific antigen(PSA) persistence after radical prostatectomy(RP).",[26,27],"Prostate Cancer","Biochemical Recurrence",[29,30,31],"Prostate cancer","Biochemical recurrence","Rezvilutamide","RECRUITING","2024-03-05",{"date":35,"type":36},"2024-03-12","ACTUAL",{"date":38,"type":36},"2023-09-07",{"date":40,"type":20},"2028-03",{"name":42,"class":43},"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School","OTHER",2,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":53,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100499281","phase-3-short-versus-long-term-androgen-deprivation-therapy-with-salvage-radiotherapy-in-prostate-cancer-uroncor-0624-100499281","NCT05781217","Short Versus Long-term Androgen Deprivation Therapy With Salvage Radiotherapy in Prostate Cancer. URONCOR 0624","Short Versus Long-term Androgen Deprivation Therapy Combined With Salvage Radiotherapy in Prostate Cancer Patients With Biochemical Recurrence After Prostatectomy: a Multicentre Phase III Randomised Controlled Trial","URONCOR 06-24","Inclusion Criteria:\n\n1. Patients with histologically-confirmed prostate cancer treated with radical prostatectomy. Patients who have not undergone lymph node dissection are eligible for inclusion.\n2. Biochemical recurrence after prostatectomy: BCR is defined as a PSA value ≥ 0.2 ng\u002FmL, with at least one confirmatory PSA determination ≥ two weeks after the first test (the confirmatory PSA level must be higher than the initial value). Patients with Gleason 8-10, pT3b or R1 are eligible for inclusion in the trial with PSA ≥ 0.15 ng\u002FmL; however, in patients with PSA \\> 0.4 ng\u002FmL, imaging tests (conventional CT and bone scans or advanced imaging techniques such as PSMA or choline PET\u002FCT) should be performed to check for metastases. In patients with PSA levels between 0.15 and 0.4 ng\u002FmL, no further tests are required to check for distant metastases prior to inclusion.\n3. Intermediate and high-risk patients according to the classification criteria proposed by González San Segundo et al. (18):\n\n   CHARACTERISTICS INTERMEDIATE RISK (≥ 2) HIGH RISK(≥ 1)\n\n   PSA at diagnosis, ng\u002FmL 0.6-1.0 ≥1.0 PSA doubling time, months 6-12 \\\u003C 6 GLEASON \u002F ISUP 7\u002F3 ≥8\u002F≥4 TNM (prostatectomy specimen) pT2-3a pN0-Mx pT3b pN0-Mx Time to biochemical recurrence, months \\>18 \\\u003C18 Margins Positive Positive\n4. Testosterone level \\> 150 ng\u002FdL at inclusion\n5. ECOG 0-1\n6. Life expectancy \\> 5 years\n7. Signed informed consent\n\nExclusion Criteria:\n\n1. Presence of pN1 disease in the original surgical specimen\n2. Presence of macroscopic disease on imaging tests. If the PSA at diagnosis is \\> 0.4 ng\u002FmL, then imaging tests (CT and bone scan and\u002For PET\u002FCT or body magnetic resonance imaging \\[MRI\\]) are required.\n3. PSA \\\u003C0.2 or \\\u003C0.15 ng\u002FmL (if Gleason score=10, pT3b, or R1 in the radical prostatectomy specimen).\n4. Previous pelvic radiotherapy\n5. Radiotherapy contraindicated\n6. Ongoing treatment with ADT or PSA-modulating drugs (e.g., finasteride, dutasteride, high dose steroids)\n7. Inability to understand the treatment protocol or sign informed consent","ALL","18 Years",{"count":56,"type":20},534,[58],"PHASE3","The optimal indication for ADT has long been a point of controversy, at least until the results of randomised trials comparing RT with and without ADT were published. NCCN guidelines and most retrospective series and left the decision to prescribe ADT in combination with RT to the discretion of the treating physician, despite a lack of clear scientific evidence to support this recommendation. The percentage of patients in those retrospective series who received hormone therapy ranged from 33% to 71%, but generally involved patients with adverse prognostic factors (Gleason score \\> 7, stage pT3-T4, PSA \\> 1 ng\u002FmL in cases with biochemical recurrence \\[BCR\\], and PSA doubling time \\[PSA-DT\\] \\\u003C 6 months). Despite the heterogeneity in those studies in terms of treatment duration, RT dose, and treatment volumes, most of the studies found that ADT significantly prolonged biochemical relapse-free survival (BRFS), especially in patients with PSA levels \\> 1 ng\u002FmL at recurrence.\n\nThe results of two randomised trials evaluating SRT with or without ADT were published in 2017, with both trials demonstrating a benefit for ADT in this clinical setting. A follow-up study confirmed the value of ADT in combination with SRT in terms of better PFS and, in the RTOG study, an improvement in overall survival (OS). Despite the lack of data from phase III trials regarding the influence of PSA-DT, the BRFS interval, and the Gleason score in terms of their effects on the clinical course of patients who develop BCR, there is strong evidence from other studies to support the use of these variables (together with age and comorbidities). Given the available evidence, we believe that these variables should be considered when determining the indications for ADT.\n\nIn line with the philosophy underlying the approach used by D'Amico to develop a risk classification system for prostate cancer patients at diagnosis, we propose three risk groups. According to Pollack et al. and Spratt et al., low-risk patients would not benefit from hormone therapy, especially long-term ADT, due to the deleterious effects of such treatment. By contrast, intermediate and high risk patients would be candidates for ADT combined with RT. However, the optimal duration of ADT in these patients (6 months vs. 2 years) remains undefined and needs to be determined prospectively in a randomised trial, similar to the approach used in the DART 05.01 trial.\n\nSRT and ADT are widely used in routine clinical practice to treat patients who develop BCR after prostatectomy. In this context, we intend to perform a multicentre, phase III trial to define the optimal duration of ADT (6 vs. 24 months).",[26,61,27,62,63],"Salvage Radiotherapy","Androgen Deprivation Therapy","Metastases-free Survival","2023-11-17",{"date":66,"type":36},"2023-11-18",{"date":68,"type":36},"2023-03-14",{"date":70,"type":20},"2032-12",{"name":72,"class":43},"Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic",17,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":21,"phases":85,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},"100499041","phase-2-adjutant-apalutamide-plus-adt-in-post-rp-patients-with-high-risk-of-recurrence-ares-study-100499041","NCT05778097","Adjutant Apalutamide Plus ADT in Post-RP Patients With High Risk of Recurrence (ARES Study)","Adjuvant Androgen Deprivation Therapy Combined With Apalutamide for Prostate Cancer Patients Post Radical-prostatectomy With High-risk of Reoccurrence: a Prospective, Single-arm, Multicenter Trial (ARES Study)","ARES","Key Inclusion Criteria:\n\n1. Prostate cancer diagnosed histologically or cytologically in males ≥18 years and ≤75 years of age;\n2. Localized prostate cancer (assessed by conventional imaging tools such as CT and bone scan) within 12 weeks after radical prostatectomy;\n3. PSA \\\u003C 0.1 ng\u002Fml within 8 weeks after surgery;\n4. Postoperative CAPRA-S score ≥ 6, suggesting a higher risk of recurrence;\n5. ECOG score at 0-1 according to the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale;\n6. Adequate organ functions:\n\n   Hematology (within 14 days before treatment: no blood transfusion, no use of granulocyte colony-stimulating factor, no use of other drugs for correction)：\n   1. Neutrophil count (NE) ≥1.5×109\u002FL;\n   2. Hemoglobin (HGB) ≥ 90 g\u002FL;\n   3. Platelet count (PLT) ≥100×109\u002FL; Coagulation function (no blood product transfusion within 14 days before treatment): international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5× upper limit of normal (ULN); Blood biochemistry (liver and kidney function)：\n\n   \u003C!-- -->\n\n   1. Creatinine clearance ≥ 30 mL\u002Fmin;\n   2. Total bilirubin (TBIL) ≤ 1.5× ULN;\n   3. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5× ULN;\n7. Ability to provide written informed consent form (ICF) and ability to understand and agree to adhere to study requirements and schedule of assessments;\n8. Patients of childbearing potential must be willing to use highly effective contraception during the study and for 12 weeks after the last dose of treatment.\n\nKey Exclusion Criteria:\n\n1. Patients with neuroendocrine, small cell, or sarcomatoid features in prostate histopathology;\n2. Pelvic lymph node metastasis (cN1) or distant metastasis (cM1) indicated preoperatively by traditional imaging procedures such as CT or bone scan;\n3. Prior treatment by androgen deprivation therapy (including medication or surgical castration), focal therapy for prostate cancer, or radiotherapy and chemotherapy for prostate cancer;\n4. Prior treatment with second-generation antiandrogen (e.g., abiraterone, apalutamide, enzalutamide, darolutamide, etc.);\n5. Any major surgery (other than radical resection) requiring general anesthesia within 28 days prior to the first dose of the study;\n6. Other malignancies present or occurred in the past 2 years, except cured non-melanoma skin cancers and superficial bladder tumors (Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating of basement membrane);\n7. Arterial\u002Fvenous thrombotic events (such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism) or anticoagulant therapy with warfarin or heparin within 6 months before the study;\n8. Corrected QT interval (QTc) of heart rate \\> 500 ms; patients with QTc prolonged but \\\u003C 500 ms should be assessed by a cardiologist for eligibility;\n9. Severe cardiovascular diseases: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmia; Classes III-IV cardiac insufficiency according to the New York Heart Association (NYHA) Classification, or left ventricular ejection fraction (LVEF) \\\u003C 50% indicated in cardiac Doppler ultrasound;\n10. Allergy to any study drug or excipients;\n11. Active viral hepatitis requiring treatment as determined by the Investigators:\n\n    1. Chronic hepatitis B, with hepatitis B virus (HBV) deoxyribonucleic acid (DNA) ≥ 500 IU\u002FmL (2500 copies\u002FmL) (HBV DNA testing only for patients with positive test for Hepatitis B surface antigen or core antibody);\n    2. Positive for Hepatitis C virus (HCV) ribonucleic acid (RNA) test (HCV RNA test only for patients with positive HCV antibodies);\n12. Any present active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism), or known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation, or long-term heavy use of hormones or other immunomodulators, or other conditions assessed by the Investigator as having an impact on study treatment;\n13. Active infection;\n14. History of interstitial lung disease or uncontrolled systemic disease, including diabetes, hypertension, acute lung disease, etc.;\n15. Known to have human immunodeficiency virus (HIV) infection;\n16. History of epilepsy or conditions that may induce epilepsy\n17. The presence of an underlying medical condition alcohol\u002Fdrug abuse or dependence that is detrimental to the administration of the study drugs, or that may affect the interpretation of the results, or that places the patient at high risk of developing treatment complications;\n18. Men who have sexual activity with women of childbearing potential, unless they:\n\n    Agree to use condom or spermicidal foam\u002Fgel\u002Fdiaphragm\u002Fcream\u002Fsuppository Agree not to donate sperm during the study and for at least 3 months after receiving the last dose of study drug No birth plan during the study or within 3 months after the last dose of study drug\n19. Concurrent participation in another therapeutic clinical study.","75 Years",{"count":84,"type":20},103,[23],"ARES is a multicenter, single-arm, phase 2 trial to evaluate the efficacy and safety of ADT in combination with apalutamide as an adjuvant regimen for patients with high risk of recurrence after radical prostatectomy.",[26,27,88],"High Risk",[90,91,92,93],"prostate cancer biochemical recurrence","apalutamide","adjuvant treatment","post-radical prostatectomy","NOT_YET_RECRUITING","2023-03-17",{"date":97,"type":36},"2023-03-21",{"date":99,"type":20},"2023-04-01",{"date":101,"type":20},"2026-12-31",{"name":42,"class":43},3,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":21,"phases":113,"briefSummary":114,"conditions":115,"keywords":116,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":123,"locationsCount":44},"100497155","phase-2-rezvilutamide-in-patients-with-biochemical-recurrence-after-radical-prostatectomy-for-prostate-cancer-100497155","NCT05753566","Rezvilutamide in Patients With Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer","Efficacy and Safety of Rezvilutamide in Patients With Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer: A Prospective, Multi-centre Study","Main Inclusion Criteria:\n\n1. Age ≥ 40 years, male.\n2. Patients with histologically-confirmed diagnosis of prostate adenocarcinoma.\n3. pathologically node-negative (pN0) or pathologically node cannot be assessed (pNx);\n4. Patients with PSA \\\u003C 0.1ng\u002Fml within 8 weeks after radical prostatectomy (RP) and maintained for at least 6 months;\n5. Biochemical recurrence (two consecutive rises in PSA with absolute values \\> 0.2ng\u002Fml, the time interval ≥ 2 weeks apart ) and no local recurrence or distant metastatic lesions on conventional imaging (bone scan and CT\u002FMRI scan);\n6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1;\n7. Estimated life expectancy \\>10 year;\n8. Adequate laboratory parameters\n\n   * Absolute Neutrophil Count (ANC) ≥ 1.5 x 10\\^9\u002FL\n   * Platelet count (PLT) ≥ 100 x 10\\^9\u002FL\n   * Haemoglobin (Hb) ≥ 90 g\u002FL\n   * Serum creatinine (Cr) ≤ 1.5 x upper limit of normal(ULN) or creatinine clearance \\> 50 ml\u002Fmin.\n   * Total bilirubin (TBIL) ≤ 1.5 x ULN.\n   * Glutamic oxaloacetic transaminase (AST\u002FSGOT) or glutamic alanine transaminase (ALT\u002FSGPT) levels ≤ 2.5 x ULN.\n   * International normalised ratio (INR) ≤1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT)≤1.5 x ULN .\n   * Left ventricular ejection fraction (LVEF) ≥ 50%.\n9. Patients able to comply with the protocol. Arm 1 subjects are proposed to receive salvage radiation therapy, while arm 2 subjects are not suitable for or refuse radiation therapy.\n10. Signed informed consent.\n\nMain Exclusion Criteria:\n\n1. Prior hormonal therapy (antiandrogens or gonadotropin releasing hormone) or prior radiotherapy to pelvic .\n2. Postoperative biochemical recurrence with PSA \\> 2 ng\u002Fml.\n3. Postoperative pathology containing neuro-endocrine differentiation or small cell features.\n4. Prior malignancy other than prostate cancer in the past three years.\n5. History of any of the following:\n\n   * Seizure or known condition that may pre-dispose to seizure\n   * Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to entry.\n   * Active infection (eg, human immunodeficiency virus \\[HIV\\] or viral hepatitis)\n6. Any other serious or uncontrolled illness which in the opinion of the investigator makes it undesirable for the patient to enter the trial.",{"count":112,"type":20},96,[23],"To evaluate the efficacy and safety of rezvilutamide in combination with androgen deprivation therapy(ADT) and standard salvage radiation therapy(SRT) or rezvilutamide in combination with ADT in prostate cancer patients with biochemical recurrence of prostate-specific antigen(PSA) persistence after radical prostatectomy(RP).",[26,27],[29,30,31],"2023-03-02",{"date":119,"type":36},"2023-03-06",{"date":121,"type":20},"2023-03",{"date":40,"type":20},{"name":42,"class":43},{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":16,"minAge":132,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":21,"phases":135,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":44},"100356363","salvage-hypofractionated-accelerated-versus-standard-radiotherapy-for-biochemical-failure-after-prostatectomy-100356363","NCT03920033","Salvage Hypofractionated Accelerated Versus Standard Radiotherapy for Biochemical Failure After Prostatectomy","Comparison of Salvage Hypofractionated Accelerated Versus Standard Radiotherapy for Biochemical Recurrence After Radical Prostatectomy (SHARE Trial): a Prospective, Randomized Controlled, Open-label, Multi Center, Superiority Study","SHARE","Inclusion Criteria:\n\n* Pathologically confirmed intermediate- or high-risk prostate cancer\n* Biochemical recurrence after radical prostatectomy (Definition: Serial elevation of PSA over 0.2 ng\u002FmL and \\\u003C=1.0 ng\u002FmL)\n* ECOG performance status 0-1\n* Appropriate values of blood tests within 6 months after enrollment Absolute neutrophil count (ANC) ≥ 1500 cells\u002Fmm3 Platelets ≥ 50,000 cells\u002Fmm3 Hemoglobin ≥ 8.0 g\u002Fdl\n* Appropriate values of kidney function within 6 months after enrollment Creatinine \\\u003C 2.0 ng\u002FdL\n* Appropriate values of liver function within 6 months after enrollment total bilirubin \\\u003C 1.5 X maximum normal value alanine aminotransferase or aspartate aminotransferase \\\u003C 2.5 X maximum normal value\n\nExclusion Criteria:\n\n* Clinically gross recurrent tumor\n* Presence of distant metastasis\n* Presence of pelvic LN metastasis\n* History of pelvic irradiation\n* History of cryotherapy or brachytherapy for prostate cancer\n* Double primary cancer other than skin\u002Fthyroid cancer\n* Combined serious morbidity","20 Years",{"count":134,"type":20},288,[136],"NA","Patients with a biochemical recurrence after radical prostatectomy for moderate- or high- risk prostate cancer are randomly assigned to hypofractionated, accelerated high dose radiation therapy group (65 Gy, 26 fractions) and a control group of standard treatment group (66 Gy, 33 fractions). The criteria for stratification at randomization include 1) risk groups, 2) androgen deprivation therapy, and 3) PSA before salvage radiation therapy, which affect biochemical recurrence.\n\nIt is expected that hypofractionated, accelerated high dose radiation therapy will have a superiority in terms of biochemical control to conventional radiation therapy, and the present study would like to confirm this. In addition, we aimed to evaluate and compare the toxicity and quality of life index of two radiation therapy regimens.",[26,27,139,140,141,142,143,144],"Radiation","Hypofractionation","Dose Escalation","Survival","Radiation Toxicity","Quality of Life","2021-01-15",{"date":147,"type":36},"2021-01-20",{"date":149,"type":36},"2019-05-01",{"date":151,"type":20},"2027-01-01",{"name":153,"class":43},"Asan Medical Center"]