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.

NCT07483658 | Recruiting DMC

• 2 other identifiers: MP-20-2026-8430PCS XIII
• Study Type: interventional
• Target: 434
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Reccurent/Metastatic Solid Tumor Disease; Prostate Cancer (Post Prostatectomy); Prostate Cancer; Prostatic Neoplasms; Neoplasm Recurrence, Local; Biochemical Recurrence of Malignant Neoplasm of Prostate

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

Outcome Measures

Primary Outcomes (1)

• Incidence of Grade 2 or Higher Genitourinary (GU) or Gastrointestinal (GI) Toxicity

  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.

  Within 24 months after completion of radiotherapy.

Secondary Outcomes (8)

• Biochemical Progression-Free Survival (bPFS)

  Up to 10 years post-treatment.

• Progression-Free Survival (PFS)

  Up to 10 years post-treatment.

• Metastasis-Free Survival (MFS)

  Up to 10 years post-treatment.

• Time to Initiation of Systemic Salvage Therapy

  Up to 10 years post-treatment.

• Overall Survival (OS)

  Up to 10 years post-treatment.

Study Arms (2)

Arm A

ACTIVE COMPARATOR

Prostate bed 62.5 Gy / 25 Pelvis 45 Gy / 25 (+/-55 Gy/25) ADT

Radiation: Standard Fractionation Post-Operative Salvage Radiotherapy (25 fractions); Drug: Androgen Deprivation Therapy (ADT)

Arm B

EXPERIMENTAL

Prostate bed 52.5 Gy / 20 Pelvis 43 Gy / 20 (+/-52 Gy/20) ADT

Radiation: Hypofractionated Post-Operative Salvage Radiotherapy (20 fractions); Drug: Androgen Deprivation Therapy (ADT)

Interventions

Standard Fractionation Post-Operative Salvage Radiotherapy (25 fractions) RADIATION

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

Arm A

Hypofractionated Post-Operative Salvage Radiotherapy (20 fractions) RADIATION

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

Arm B

Androgen Deprivation Therapy (ADT) DRUG

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.

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead
• TerSera Therapeutics LLC: collaborator

Study Sites (4)

Gatineau Hospital

Gatineau, Quebec, Canada

NOT YET RECRUITING

Hôpital Général Juif

Montreal, Quebec, H3T 1E2, Canada

NOT YET RECRUITING

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

NOT YET RECRUITING

CHU de Québec-Université Laval

Québec, Quebec, G1G 5X1, Canada

RECRUITING

Related Publications (6)

• 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: 35569466 BACKGROUND

• 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: 28146658 BACKGROUND

• 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: 38763153 BACKGROUND

• 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: 37150260 BACKGROUND

• 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: 38483412 BACKGROUND

• 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.

  PMID: 34953525 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasm Recurrence, Local; Gastrointestinal Diseases; Urologic Diseases; Radiation Injuries

Interventions

Androgen Antagonists

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Digestive System Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Eric Vigneault, MD, MSc

  CHU de Québec-Université Laval

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric Vigneault, MD, MSc

CONTACT

418 691-5264; eric.vigneault.med@ssss.gouv.qc.ca

Damien Carignan, PhD

CONTACT

418 525-4444; damien.carignan@crchudequebec.ulaval.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 19, 2026
• Study Start: May 13, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): February 1, 2036
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)