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.

Официальное название

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)

Обзор

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. Why 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. What is being compared? Standard treatment (Arm A): 25 sessions (about 5 weeks) Prostate bed: 62.5 Gy Pelvis: 45 Gy Shorter treatment (Arm B): 20 sessions (about 4 weeks) Prostate bed: 52.5 Gy Pelvis: 43 Gy Both groups may also receive hormone therapy (ADT) for 6-24 months. Main 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. Other Things to be Measured Cancer control (PSA levels, spread of disease) Survival Quality of life (urinary, bowel, sexual health questionnaires) Who can join? Men who: Had prostate surgery Have a detectable PSA (≥0.2 ng/mL) No distant metastasis Are in good general health (ECOG 0-2) How long will the study last? About 12 years total: 2 years to enroll patients 10 years of follow-up

Вмешательства

• Лучевая терапия Standard Fractionation Post-Operative Salvage Radiotherapy (25 fractions)
  Type: Radiation Description: External beam radiotherapy delivered to the prostate bed and pelvis using VMAT/IMRT techniques. Dose and Schedule: Prostate bed: 62.5 Gy in 25 fractions Pelvis: 45 Gy in 25 fractions Duration: Approximately 5 weeks
• Лучевая терапия Hypofractionated Post-Operative Salvage Radiotherapy (20 fractions)
  Type: Radiation Description: External beam radiotherapy delivered to the prostate bed and pelvis using VMAT/IMRT techniques. Dose and Schedule: Prostate bed: 52.5 Gy in 20 fractions Pelvis: 43 Gy in 20 fractions Duration: Approximately 4 weeks
• Препарат Androgen Deprivation Therapy (ADT)
  Type: Drug Description: Hormonal therapy with a luteinizing hormone-releasing hormone (LHRH) agonist (e.g., goserelin) ± short-term anti-androgen. Duration: 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.

Первичные конечные точки

• Incidence of Grade 2 or Higher Genitourinary (GU) or Gastrointestinal (GI) Toxicity [Срок оценки: Within 24 months after completion of radiotherapy.]

Вторичные конечные точки (8)

• Biochemical Progression-Free Survival (bPFS) [Срок оценки: Up to 10 years post-treatment.]
• Progression-Free Survival (PFS) [Срок оценки: Up to 10 years post-treatment.]
• Metastasis-Free Survival (MFS) [Срок оценки: Up to 10 years post-treatment.]
• Time to Initiation of Systemic Salvage Therapy [Срок оценки: Up to 10 years post-treatment.]
• Overall Survival (OS) [Срок оценки: Up to 10 years post-treatment.]
• Expanded Prostate Cancer Index Composite-26 (EPIC-26) [Срок оценки: Baseline, every 3 months for 1 year, every 6 months up to 24 months, then annually up to 5 years.]
• International Prostate Symptom Score (IPSS) [Срок оценки: Baseline, every 3 months for 1 year, every 6 months up to 24 months, then annually up to 5 years.]
• Functional Assessment of Cancer Therapy - Prostate (FACT-P) [Срок оценки: Baseline, every 3 months for 1 year, every 6 months up to 24 months, then annually up to 5 years.]

Критерии участия

Критерии включения

• Histologically confirmed prostate adenocarcinoma.
• Prior radical prostatectomy with detectable PSA (≥0.2 ng/mL).
• No evidence of distant metastasis (confirmed via bone scan and CT/MRI or TEP-PSMA if PSA is above 0.5 ng /ml).
• Patient with Nodal recurrence within the pelvis are eligible
• ECOG performance status 0-2.
• Age ≥ 18 years.
• Adequate baseline renal, hepatic, and hematologic function.

Критерии исключения

• Prior pelvic radiotherapy.
• Macroscopic local relapse on imaging
• Presence of metastatic disease.
• Active inflammatory bowel disease or other GI conditions predisposing to radiation toxicity.
• Uncontrolled comorbidities affecting study participation.
• Prior systemic therapy for recurrent prostate cancer (except ADT within 6 months).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 4 центра

• Gatineau Hospital — Gatineau
• Hôpital Général Juif — Montreal
• McGill University Health Centre — Montreal
• CHU de Québec-Université Laval — Québec

Публикации

• 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 in PMID 35569466
• 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/NEJM PMID 28146658
• 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, Parm PMID 38763153
• 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. PMID 37150260
• 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 Ran PMID 38483412
• 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 PMID 34953525

Идентификаторы

NCT: NCT07483658 · MP-20-2026-8430 · PCS XIII

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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