Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 4:22 AM
Study NCT ID:
NCT07483658
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-19
First Post:
2026-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-inferiority Study Comparing Salvage Pelvic Radiotherapy in 25 Fractions (62.5 Gy/25) Versus 20 Fractions (52.5 Gy/20) for Recurrent Prostate Cancer After Surgery.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D009364', 'term': 'Neoplasm Recurrence, Local'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D011832', 'term': 'Radiation Injuries'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000726', 'term': 'Androgen Antagonists'}], 'ancestors': [{'id': 'D006727', 'term': 'Hormone Antagonists'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 434}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2036-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-16', 'studyFirstSubmitDate': '2026-03-13', 'studyFirstSubmitQcDate': '2026-03-16', 'lastUpdatePostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Grade 2 or Higher Genitourinary (GU) or Gastrointestinal (GI) Toxicity', 'timeFrame': 'Within 24 months after completion of radiotherapy.', 'description': 'The proportion of patients experiencing Grade 2 or higher GU or GI adverse events, assessed according to CTCAE v5.0 criteria, following post-operative salvage radiotherapy. This outcome measures treatment-related toxicity in both study arms.'}], 'secondaryOutcomes': [{'measure': 'Biochemical Progression-Free Survival (bPFS)', 'timeFrame': 'Up to 10 years post-treatment.', 'description': 'Time from the end of radiotherapy to biochemical recurrence, defined as PSA ≥ 0.2 ng/mL and rising.'}, {'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'Up to 10 years post-treatment.', 'description': 'Time from the end of radiotherapy to biochemical recurrence, metastatic recurrence, or death from any cause, whichever occurs first.'}, {'measure': 'Metastasis-Free Survival (MFS)', 'timeFrame': 'Up to 10 years post-treatment.', 'description': 'Time from the end of radiotherapy to the first occurrence of metastatic disease or death from any cause.'}, {'measure': 'Time to Initiation of Systemic Salvage Therapy', 'timeFrame': 'Up to 10 years post-treatment.', 'description': 'Time from the end of radiotherapy to the start of systemic therapy (e.g., ADT, ARPis, chemotherapy).'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to 10 years post-treatment.', 'description': 'Time from the end of radiotherapy to death from any cause.'}, {'measure': 'Expanded Prostate Cancer Index Composite-26 (EPIC-26)', 'timeFrame': 'Baseline, every 3 months for 1 year, every 6 months up to 24 months, then annually up to 5 years.', 'description': 'EPIC-26 is a validated 26-item, patient-reported questionnaire used to evaluate health-related quality of life, specifically urinary, bowel, sexual, and hormonal symptoms, following prostate cancer treatment. Responses are converted to a 0-100 scale. A higher score indicates better function or less bother.'}, {'measure': 'International Prostate Symptom Score (IPSS)', 'timeFrame': 'Baseline, every 3 months for 1 year, every 6 months up to 24 months, then annually up to 5 years.', 'description': 'IPSS is an 8-question tool evaluating Lower Urinary Tract Symptoms in prostate cancer and benign prostatic hyperplasia. Scores of 0-7 are mild, 8-19 moderate, and 20-35 severe. It measures frequency, urgency, straining, and nocturia, aiding treatment monitoring.'}, {'measure': 'Functional Assessment of Cancer Therapy - Prostate (FACT-P)', 'timeFrame': 'Baseline, every 3 months for 1 year, every 6 months up to 24 months, then annually up to 5 years.', 'description': 'The FACT-P is a 39-item validated instrument used to evaluate Health-Related Quality of Life (HRQoL) specifically in prostate cancer patients. Each item is rated on a 5-point Likert scale (0 to 4). The total score ranges from 0 to 156, where a higher score indicates a better quality of life.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Radiotherapy, Adjuvant', 'Radiotherapy, Intensity-Modulated', 'Radiotherapy, High-Dose Hypofractionated', 'Pelvic Radiotherapy', 'Androgen Deprivation Therapy', 'Randomized Controlled Trials', 'Noninferiority Trials', 'Quality of Life', 'Treatment Outcome', 'Gastrointestinal Diseases / chemically induced', 'Urinary Tract Diseases / chemically induced', 'Radiation Injuries'], 'conditions': ['Reccurent/Metastatic Solid Tumor Disease', 'Prostate Cancer (Post Prostatectomy)', 'Prostate Cancer', 'Prostatic Neoplasms', 'Neoplasm Recurrence, Local', 'Biochemical Recurrence of Malignant Neoplasm of Prostate']}, 'referencesModule': {'references': [{'pmid': '35569466', 'type': 'BACKGROUND', 'citation': 'Pollack A, Karrison TG, Balogh AG, Gomella LG, Low DA, Bruner DW, Wefel JS, Martin AG, Michalski JM, Angyalfi SJ, Lukka H, Faria SL, Rodrigues GB, Beauchemin MC, Lee RJ, Seaward SA, Allen AM, Monitto DC, Seiferheld W, Sartor O, Feng F, Sandler HM. The addition of androgen deprivation therapy and pelvic lymph node treatment to prostate bed salvage radiotherapy (NRG Oncology/RTOG 0534 SPPORT): an international, multicentre, randomised phase 3 trial. Lancet. 2022 May 14;399(10338):1886-1901. doi: 10.1016/S0140-6736(21)01790-6.'}, {'pmid': '28146658', 'type': 'BACKGROUND', 'citation': 'Shipley WU, Seiferheld W, Lukka HR, Major PP, Heney NM, Grignon DJ, Sartor O, Patel MP, Bahary JP, Zietman AL, Pisansky TM, Zeitzer KL, Lawton CA, Feng FY, Lovett RD, Balogh AG, Souhami L, Rosenthal SA, Kerlin KJ, Dignam JJ, Pugh SL, Sandler HM; NRG Oncology RTOG. Radiation with or without Antiandrogen Therapy in Recurrent Prostate Cancer. N Engl J Med. 2017 Feb 2;376(5):417-428. doi: 10.1056/NEJMoa1607529.'}, {'pmid': '38763153', 'type': 'BACKGROUND', 'citation': 'Parker CC, Kynaston H, Cook AD, Clarke NW, Catton CN, Cross WR, Petersen PM, Persad RA, Pugh CA, Saad F, Logue J, Payne H, Bower LC, Brawley C, Rauchenberger M, Barkati M, Bottomley DM, Brasso K, Chung HT, Chung PWM, Conroy R, Falconer A, Ford V, Goh CL, Heath CM, James ND, Kim-Sing C, Kodavatiganti R, Malone SC, Morris SL, Nabid A, Ong AD, Raman R, Rodda S, Wells P, Worlding J, Parulekar WR, Parmar MKB, Sydes MR; RADICALS investigators. Duration of androgen deprivation therapy with postoperative radiotherapy for prostate cancer: a comparison of long-course versus short-course androgen deprivation therapy in the RADICALS-HD randomised trial. Lancet. 2024 Jun 1;403(10442):2416-2425. doi: 10.1016/S0140-6736(24)00549-X. Epub 2024 May 16.'}, {'pmid': '37150260', 'type': 'BACKGROUND', 'citation': 'Petersen PM, Cook AD, Sydes MR, Clarke N, Cross W, Kynaston H, Logue J, Neville P; Patient Representative; Payne H, Parmar MKB, Parulekar W, Persad R, Saad F, Stirling A, Parker CC, Catton C. Salvage Radiation Therapy After Radical Prostatectomy: Analysis of Toxicity by Dose-Fractionation in the RADICALS-RT Trial. Int J Radiat Oncol Biol Phys. 2023 Nov 1;117(3):624-629. doi: 10.1016/j.ijrobp.2023.04.032. Epub 2023 May 6.'}, {'pmid': '38483412', 'type': 'BACKGROUND', 'citation': 'Buyyounouski MK, Pugh SL, Chen RC, Mann MJ, Kudchadker RJ, Konski AA, Mian OY, Michalski JM, Vigneault E, Valicenti RK, Barkati M, Lawton CAF, Potters L, Monitto DC, Kittel JA, Schroeder TM, Hannan R, Duncan CE, Rodgers JP, Feng F, Sandler HM. Noninferiority of Hypofractionated vs Conventional Postprostatectomy Radiotherapy for Genitourinary and Gastrointestinal Symptoms: The NRG-GU003 Phase 3 Randomized Clinical Trial. JAMA Oncol. 2024 May 1;10(5):584-591. doi: 10.1001/jamaoncol.2023.7291.'}, {'pmid': '34953525', 'type': 'BACKGROUND', 'citation': "Attard G, Murphy L, Clarke NW, Cross W, Jones RJ, Parker CC, Gillessen S, Cook A, Brawley C, Amos CL, Atako N, Pugh C, Buckner M, Chowdhury S, Malik Z, Russell JM, Gilson C, Rush H, Bowen J, Lydon A, Pedley I, O'Sullivan JM, Birtle A, Gale J, Srihari N, Thomas C, Tanguay J, Wagstaff J, Das P, Gray E, Alzoueb M, Parikh O, Robinson A, Syndikus I, Wylie J, Zarkar A, Thalmann G, de Bono JS, Dearnaley DP, Mason MD, Gilbert D, Langley RE, Millman R, Matheson D, Sydes MR, Brown LC, Parmar MKB, James ND; Systemic Therapy in Advancing or Metastatic Prostate cancer: Evaluation of Drug Efficacy (STAMPEDE) investigators. Abiraterone acetate and prednisolone with or without enzalutamide for high-risk non-metastatic prostate cancer: a meta-analysis of primary results from two randomised controlled phase 3 trials of the STAMPEDE platform protocol. Lancet. 2022 Jan 29;399(10323):447-460. doi: 10.1016/S0140-6736(21)02437-5. Epub 2021 Dec 23."}]}, 'descriptionModule': {'briefSummary': 'Study Overview This research compares two types of post-operative salvage radiotherapy (SRT) for men with prostate cancer who have had surgery but show signs of recurrence (detectable PSA). The goal is to see if a shorter treatment schedule is as safe and effective as the standard schedule.\n\nWhy is this study important? After prostate surgery, cancer can return in up to 70-80% of high-risk patients. Radiotherapy helps control this, but the best way to deliver it-especially the number of sessions and whether to treat the pelvic area-is still being studied. Shorter treatments could mean less time in therapy and better quality of life, if such treatments are proven safe.\n\nWhat is being compared?\n\nStandard treatment (Arm A):\n\n25 sessions (about 5 weeks) Prostate bed: 62.5 Gy Pelvis: 45 Gy\n\nShorter treatment (Arm B):\n\n20 sessions (about 4 weeks) Prostate bed: 52.5 Gy Pelvis: 43 Gy\n\nBoth groups may also receive hormone therapy (ADT) for 6-24 months.\n\nMain Goal To check if the shorter treatment causes no more side effects (urinary or bowel problems) than the standard treatment, while keeping cancer control similar.\n\nOther Things to be Measured\n\nCancer control (PSA levels, spread of disease) Survival Quality of life (urinary, bowel, sexual health questionnaires)\n\nWho can join?\n\nMen who:\n\nHad prostate surgery Have a detectable PSA (≥0.2 ng/mL) No distant metastasis Are in good general health (ECOG 0-2)\n\nHow long will the study last?\n\nAbout 12 years total:\n\n2 years to enroll patients 10 years of follow-up'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed prostate adenocarcinoma.\n* Prior radical prostatectomy with detectable PSA (≥0.2 ng/mL).\n* No evidence of distant metastasis (confirmed via bone scan and CT/MRI or TEP-PSMA if PSA is above 0.5 ng /ml).\n* Patient with Nodal recurrence within the pelvis are eligible\n* ECOG performance status 0-2.\n* Age ≥ 18 years.\n* Adequate baseline renal, hepatic, and hematologic function.\n\nExclusion Criteria:\n\n* Prior pelvic radiotherapy.\n* Macroscopic local relapse on imaging\n* Presence of metastatic disease.\n* Active inflammatory bowel disease or other GI conditions predisposing to radiation toxicity.\n* Uncontrolled comorbidities affecting study participation.\n* Prior systemic therapy for recurrent prostate cancer (except ADT within 6 months).'}, 'identificationModule': {'nctId': 'NCT07483658', 'acronym': 'HYP-OP-RT', 'briefTitle': 'Non-inferiority Study Comparing Salvage Pelvic Radiotherapy in 25 Fractions (62.5 Gy/25) Versus 20 Fractions (52.5 Gy/20) for Recurrent Prostate Cancer After Surgery.', 'organization': {'class': 'OTHER', 'fullName': 'CHU de Quebec-Universite Laval'}, 'officialTitle': 'Non-Inferiority Study Comparing Hypofractionated Post-Operative Salvage Radiotherapy Regimens: 45/62.5 Gy in 25 Fractions vs. 43/52.5 Gy in 20 Fractions for Grade 2+ GU or GI Toxicity (HYP-OP-RT)', 'orgStudyIdInfo': {'id': 'MP-20-2026-8430'}, 'secondaryIdInfos': [{'id': 'PCS XIII', 'type': 'OTHER', 'domain': "Groupe d'Étude en Oncologie du Québec"}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm A', 'description': 'Prostate bed 62.5 Gy / 25 Pelvis 45 Gy / 25 (+/-55 Gy/25) ADT', 'interventionNames': ['Radiation: Standard Fractionation Post-Operative Salvage Radiotherapy (25 fractions)', 'Drug: Androgen Deprivation Therapy (ADT)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B', 'description': 'Prostate bed 52.5 Gy / 20 Pelvis 43 Gy / 20 (+/-52 Gy/20) ADT', 'interventionNames': ['Radiation: Hypofractionated Post-Operative Salvage Radiotherapy (20 fractions)', 'Drug: Androgen Deprivation Therapy (ADT)']}], 'interventions': [{'name': 'Standard Fractionation Post-Operative Salvage Radiotherapy (25 fractions)', 'type': 'RADIATION', 'description': 'Type: Radiation Description: External beam radiotherapy delivered to the prostate bed and pelvis using VMAT/IMRT techniques.\n\nDose and Schedule:\n\nProstate bed: 62.5 Gy in 25 fractions Pelvis: 45 Gy in 25 fractions Duration: Approximately 5 weeks', 'armGroupLabels': ['Arm A']}, {'name': 'Hypofractionated Post-Operative Salvage Radiotherapy (20 fractions)', 'type': 'RADIATION', 'description': 'Type: Radiation Description: External beam radiotherapy delivered to the prostate bed and pelvis using VMAT/IMRT techniques.\n\nDose and Schedule:\n\nProstate bed: 52.5 Gy in 20 fractions Pelvis: 43 Gy in 20 fractions Duration: Approximately 4 weeks', 'armGroupLabels': ['Arm B']}, {'name': 'Androgen Deprivation Therapy (ADT)', 'type': 'DRUG', 'description': "Type: Drug Description: Hormonal therapy with a luteinizing hormone-releasing hormone (LHRH) agonist (e.g., goserelin) ± short-term anti-androgen.\n\nDuration: 6 to 24 months, at physician's discretion. Additional Notes: Patients with pelvic nodal disease may receive abiraterone and prednisone for 24 months as per STAMPEDE protocol.", 'armGroupLabels': ['Arm A', 'Arm B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gatineau', 'state': 'Quebec', 'country': 'Canada', 'contacts': [{'name': 'Steven Tisseverasinghe, MD', 'role': 'CONTACT', 'email': 'steven.tisseverasinghe.med@ssss.gouv.qc.ca', 'phone': '819-966-6100'}], 'facility': 'Gatineau Hospital', 'geoPoint': {'lat': 45.47723, 'lon': -75.70164}}, {'zip': 'H3T 1E2', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'contacts': [{'name': 'Tamim Niazi, MD', 'role': 'CONTACT', 'email': 'tniazi@mcgill.ca', 'phone': '514-340-8288'}], 'facility': 'Hôpital Général Juif', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H4A 3J1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'contacts': [{'name': 'James MG Tsui, MS, PhD', 'role': 'CONTACT', 'email': 'james.tsui@mcgill.ca', 'phone': '514-934-4400'}], 'facility': 'McGill University Health Centre', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1G 5X1', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'contacts': [{'name': 'Eric Vigneault, MD, MSc', 'role': 'CONTACT', 'email': 'eric.vigneault.med@ssss.gouv.qc.ca', 'phone': '418 691-5264'}, {'name': 'Damien Carignan, PhD', 'role': 'CONTACT', 'email': 'damien.carignan@crchudequebec.ulaval.ca', 'phone': '418 525-4444', 'phoneExt': '67853'}], 'facility': 'CHU de Québec-Université Laval', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'centralContacts': [{'name': 'Eric Vigneault, MD, MSc', 'role': 'CONTACT', 'email': 'eric.vigneault.med@ssss.gouv.qc.ca', 'phone': '418 691-5264'}, {'name': 'Josée Allard, BInf', 'role': 'CONTACT', 'email': 'josee.allard@chudequebec.ca', 'phone': '418 525-4444', 'phoneExt': '67296'}], 'overallOfficials': [{'name': 'Eric Vigneault, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Québec-Université Laval'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Institutional policies are against sharing IPD.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CHU de Quebec-Universite Laval', 'class': 'OTHER'}, 'collaborators': [{'name': 'TerSera Therapeutics LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}