[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06369610":3,"trial-entities:NCT06369610":199,"trial-summary:NCT06369610":203},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":138,"secondary_outcomes":143,"sex":144,"minimum_age":145,"maximum_age":15,"healthy_volunteers":146,"eligibility_criteria":147,"std_ages":168,"locations":171,"central_contacts":190,"overall_officials":192,"references":194,"see_also_links":195},"NCT06369610","GMROA2256","Risk Stratified De-escalated Hormone Therapy With Radiation Therapy for the Treatment of Prostate Cancer","Risk Stratified De-Escalated De-Intensified Treatment for High Risk Prostate Cancer Patients Based on Pathologic Criteria, Genetic Score, and Biologic Imaging","RECRUITING","2027-04-22","2025-11","2025-11-14","2024-04-22","Mayo Clinic","OTHER",null,"This phase II trial tests how well risk based de-escalated hormone therapy (i.e., fewer treatments) with radiation works in treating patients with prostate cancer. Androgen deprivation therapy (ADT), such as gonadotropin-releasing hormone analogs (LHRH) and abiraterone acetate (Zytiga), lower the amount of the male hormone, testosterone, made by the body. This may help kill or stop the growth of tumor cells that need testosterone to grow. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Research has shown that long-term ADT is beneficial for patients with high-risk prostate cancer. However, there are few studies that determine ADT treatment based on risk factors. Giving risk based de-escalated ADT with radiation therapy may be as effective as giving more ADT in treating high-risk prostate cancer.","PRIMARY OBJECTIVE:\n\nI. Recovery of the Expanded Prostate Cancer Index Composite (EPIC) hormonal domain to baseline levels at 2-years.\n\nEXPLORATORY OBJECTIVES:\n\nI. After completion of radiation therapy, determine the incidence of:\n\nIa. Grade 2 or greater genitourinary (GU) and gastrointestinal (GI) toxicity at 6 months (Common Terminology Criteria for Adverse Events \\[CTCAE\\] version 5.0); Ib. Grade 3 or greater GU and GI toxicity at 6 months (CTCAE version 5.0); Ic. Patient-reported quality of life; Id. Impotence after the use of radiation therapy at 3 years; Ie. Freedom from biochemical failure (FFBF) at 5 years; If. Clinical failure: local and\u002For distant at 5 years; Ig. Salvage androgen deprivation use (SAD) at 5 years; Ih. Progression free survival: using clinical, biochemical and SAD as events at 5 years; Ij. Overall survival at 5 years; Ik. Disease-specific survival at 5 years. II. Determine overall GI and GU toxicity.\n\nOUTLINE: Patients are assigned to 1 of 3 risk groups.\n\nGROUP I (LOW RISK): Patients undergo radiation therapy to the prostate bed over 2 - 6 weeks.\n\nGROUP II (INTERMEDIATE RISK): Patients receive ADT subcutaneously (SC) or intramuscularly (IM) for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy to the prostate bed over 2 - 6 weeks starting on week 8-10 of ADT hormone therapy.\n\nGROUP III: (HIGH RISK): Patients receive ADT SC or IM with or without abiraterone acetate for up to 18 months in the absence of disease progression or unacceptable toxicity. Patients also undergo radiation therapy to identified areas over 2 - 6 weeks starting on week 8-10 of ADT hormone therapy.\n\nAdditionally, patients undergo positron emission tomography (PET), computed tomography (CT) or magnetic resonance imaging (MRI), and blood sample collection throughout the trial.\n\nAfter completion of study treatment, patients are followed up at months 3 and 12, then yearly for up to year 5 followed by every 2 years.",[19,20],"Oligometastatic Prostate Carcinoma","Prostate Adenocarcinoma",[],"INTERVENTIONAL","TREATMENT",[25],"PHASE2",{"count":27,"type":28},110,"ESTIMATED",[30,43,54,69,84,104,116,120],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":36},"DRUG","Abiraterone Acetate","Given abiraterone acetate",[35],"Group III (ADT, radiation therapy, abiraterone acetate)",[37,38,39,40,41,42],"BR9004","BR9004-1","CB7630","JNJ-212082","Yonsa","Zytiga",{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":50},"PROCEDURE","Biospecimen Collection","Undergo blood sample collection",[48,49,35],"Group I (radiation therapy)","Group II (ADT, radiation therapy)",[51,52,53],"Biological Sample Collection","Biospecimen Collected","Specimen Collection",{"type":44,"name":55,"description":56,"armGroupLabels":57,"otherNames":58},"Computed Tomography","Undergo CT",[48,49,35],[59,60,61,62,63,64,65,66,67,68],"CAT","CAT Scan","Computed Axial Tomography","Computerized Axial Tomography","Computerized axial tomography (procedure)","Computerized Tomography","Computerized Tomography (CT) scan","CT","CT Scan","tomography",{"type":70,"name":71,"description":72,"armGroupLabels":73,"otherNames":74},"BIOLOGICAL","Gonadotropin-releasing Hormone Analog","Given SC or IM",[49,35],[75,76,77,78,79,80,81,82,83],"GnRH Agonist","GnRH Analog","Gonadotropin-Releasing Hormone Agonist","Gonadotropin-Releasing Hormone Analogue","LH-RH agonist","LH-RH Analogs","LHRH Agonist","luteinizing hormone-releasing hormone agonist","Luteinizing Hormone-Releasing Hormone Analog",{"type":44,"name":85,"description":86,"armGroupLabels":87,"otherNames":88},"Magnetic Resonance Imaging","Undergo MRI",[48,49,35],[89,90,91,92,93,94,95,96,97,98,99,100,101,102,103],"Magnetic Resonance","Magnetic Resonance Imaging (MRI)","Magnetic resonance imaging (procedure)","Magnetic Resonance Imaging Scan","Medical Imaging, Magnetic Resonance \u002F Nuclear Magnetic Resonance","MR","MR Imaging","MRI","MRI Scan","MRIs","NMR Imaging","NMRI","Nuclear Magnetic Resonance Imaging","sMRI","Structural MRI",{"type":44,"name":105,"description":106,"armGroupLabels":107,"otherNames":108},"Positron Emission Tomography","Undergo PET",[48,49,35],[109,110,111,112,113,114,115],"Medical Imaging, Positron Emission Tomography","PET","PET Scan","Positron emission tomography (procedure)","Positron Emission Tomography Scan","Positron-Emission Tomography","PT",{"type":14,"name":117,"description":118,"armGroupLabels":119},"Questionnaire Administration","Ancillary studies",[48,49,35],{"type":121,"name":122,"description":123,"armGroupLabels":124,"otherNames":125},"RADIATION","Radiation Therapy","Undergo radiation therapy",[48,49,35],[126,127,128,129,130,131,132,133,134,135,136,137],"Cancer Radiotherapy","Energy Type","ENERGY_TYPE","Irradiate","Irradiated","Irradiation","Radiation","Radiation Therapy, NOS","Radiotherapeutics","Radiotherapy","RT","Therapy, Radiation",[139],{"measure":140,"description":141,"timeFrame":142},"Hormonal domain scores","Measured by the Expanded Prostate Cancer Index Composite. Comparison will be made using a one-sided, paired-difference t-test, with a Type I error rate of 0.025.","At baseline and up to 2 years",[],"ALL","18 Years",false,{"inclusion":148,"exclusion":157,"raw_text":167},[149,150,151,152,153,154,155,156],"Histologically confirmed high risk prostate adenocarcinoma","Pathologic stages T1c-T4, N0-Nx-N1, M0-1 as staged by the pathology report (AJCC Criteria 8th Edition \\[Ed\\].)","One or more high risk features including Gleason 8-10, T3-T4, prostate specific antigen (PSA) ≥ 20","Eastern Cooperative Oncology Group (ECOG) performance status 0-2","Patients must sign institutional review board (IRB) approved study specific informed consent","Patients must complete all required pre-entry tests","Patients must be at least 18 years old","Oligometastatic prostate cancer defined as disease in up to 5 distant or regional areas (group 3 only)",[158,159,160,161,162,163,164,165,166],"Previous pelvic radiation","Prior androgen suppression therapy for prostate cancer for more than 6 months","Active rectal diverticulitis, Crohn's disease affecting the rectum or ulcerative colitis (non-active diverticulitis and Crohn's disease not affecting the rectum are allowed)","Prior systemic chemotherapy for prostate cancer","History of proximal urethral stricture requiring dilatation","Current and continuing anticoagulation with warfarin sodium (Coumadin), heparin, low-molecular weight heparin, clopidogrel bisulfate (Plavix), or equivalent (unless it can be stopped to manage treatment related toxicity, to have a biopsy if needed, or place markers)","Major medical, addictive or psychiatric illness which in the investigator's opinion, will prevent the consent process, completion of the treatment and\u002For interfere with follow-up. (Consent by legal authorized representative is not permitted for this study)","Evidence of any other cancer within the past 5 years and \\\u003C 50% probability of a 5 year survival. (Prior or concurrent diagnosis of basal cell or non-invasive squamous cell cancer of the skin is allowed)","History of myocardial infarction or decompensated congestive heart failure (CHF) within the last 6 months","Inclusion Criteria:\n\n* Histologically confirmed high risk prostate adenocarcinoma\n* Pathologic stages T1c-T4, N0-Nx-N1, M0-1 as staged by the pathology report (AJCC Criteria 8th Edition \\[Ed\\].)\n* One or more high risk features including Gleason 8-10, T3-T4, prostate specific antigen (PSA) ≥ 20\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Patients must sign institutional review board (IRB) approved study specific informed consent\n* Patients must complete all required pre-entry tests\n* Patients must be at least 18 years old\n* Oligometastatic prostate cancer defined as disease in up to 5 distant or regional areas (group 3 only)\n\nExclusion Criteria:\n\n* Previous pelvic radiation\n* Prior androgen suppression therapy for prostate cancer for more than 6 months\n* Active rectal diverticulitis, Crohn's disease affecting the rectum or ulcerative colitis (non-active diverticulitis and Crohn's disease not affecting the rectum are allowed)\n* Prior systemic chemotherapy for prostate cancer\n* History of proximal urethral stricture requiring dilatation\n* Current and continuing anticoagulation with warfarin sodium (Coumadin), heparin, low-molecular weight heparin, clopidogrel bisulfate (Plavix), or equivalent (unless it can be stopped to manage treatment related toxicity, to have a biopsy if needed, or place markers)\n* Major medical, addictive or psychiatric illness which in the investigator's opinion, will prevent the consent process, completion of the treatment and\u002For interfere with follow-up. (Consent by legal authorized representative is not permitted for this study)\n* Evidence of any other cancer within the past 5 years and \\\u003C 50% probability of a 5 year survival. (Prior or concurrent diagnosis of basal cell or non-invasive squamous cell cancer of the skin is allowed)\n* History of myocardial infarction or decompensated congestive heart failure (CHF) within the last 6 months",[169,170],"ADULT","OLDER_ADULT",[172],{"facility":173,"status":8,"city":174,"state":175,"zip":176,"country":177,"contacts":178,"geoPoint":187},"Mayo Clinic in Arizona","Scottsdale","Arizona","85259","United States",[179,184],{"name":180,"role":181,"phone":182,"email":183},"Clinical Trials Referral Office","CONTACT","855-776-0015","mayocliniccancerstudies@mayo.edu",{"name":185,"role":186},"Carlos E. Vargas, M.D.","PRINCIPAL_INVESTIGATOR",{"lat":188,"lon":189},33.50921,-111.89903,[191],{"name":180,"role":181,"phone":182,"email":183},[193],{"name":185,"affiliation":13,"role":186},[],[196],{"label":197,"url":198},"Mayo Clinic Clinical Trials","https:\u002F\u002Fwww.mayo.edu\u002Fresearch\u002Fclinical-trials",{"nct_id":4,"conditions":200,"biomarkers":202},[201],"Prostate Carcinoma",[],{"nct_id":4,"found":204,"summary":205,"prompt_version":215},true,{"design":206,"status":207,"heading":208,"summary":209,"follow_up":210,"word_count":211,"commitments":212,"compensation":213,"drugs_mentioned":214},"This is a Phase II interventional study that plans to enroll 110 participants. Participants are assigned to one of three risk groups.","completed","Risk-Stratified Hormone and Radiation Therapy for Prostate Cancer","This study is looking at how well a risk-based approach to hormone therapy, combined with radiation, works for people with prostate cancer. The study uses abiraterone acetate (Zytiga) and gonadotropin-releasing hormone analogs (LHRH), which are medicines that lower testosterone to help stop cancer growth. Radiation therapy uses high-energy rays to kill cancer cells. The goal is to see if this approach helps patients recover their hormone-related quality of life. This study is for people with high-risk prostate cancer, aged 18 and older, who meet specific health criteria. The study plans to enroll 110 participants, but its current status is unclear.","Your hormonal quality of life will be measured up to 2 years. Other outcomes, such as toxicity and survival, will be followed for up to 5 years.",100,"You would undergo blood sample collection, CT scans, and MRI scans. You may also receive hormone therapy for up to 12 months and radiation therapy over 2-6 weeks. Your hormonal quality of life will be measured at baseline and up to 2 years.","Not stated in the trial record.",[32,71],"v2"]