Status
Recruiting
Phase
Not applicable
Enrollment
434
Locations
4
Results
Not posted
Publications
6
Study 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
Interventions
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
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
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.
Timeline
First posted
Mar 19, 2026
Study start
May 13, 2026
Primary completion
Dec 2029
Study completion
Feb 2036
Results posted
Not reported
Registry updated
Jul 1, 2026
Outcomes
Incidence of Grade 2 or Higher Genitourinary (GU) or Gastrointestinal (GI) Toxicity
Time frame · Within 24 months after completion of radiotherapy.
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.
Biochemical Progression-Free Survival (bPFS)
Time frame · Up to 10 years post-treatment.
Time from the end of radiotherapy to biochemical recurrence, defined as PSA ≥ 0.2 ng/mL and rising.
Progression-Free Survival (PFS)
Time frame · Up to 10 years post-treatment.
Time from the end of radiotherapy to biochemical recurrence, metastatic recurrence, or death from any cause, whichever occurs first.
Metastasis-Free Survival (MFS)
Time frame · Up to 10 years post-treatment.
Time from the end of radiotherapy to the first occurrence of metastatic disease or death from any cause.
Time to Initiation of Systemic Salvage Therapy
Time frame · Up to 10 years post-treatment.
Time from the end of radiotherapy to the start of systemic therapy (e.g., ADT, ARPis, chemotherapy).
Overall Survival (OS)
Time frame · Up to 10 years post-treatment.
Time from the end of radiotherapy to death from any cause.
Expanded Prostate Cancer Index Composite-26 (EPIC-26)
Time frame · Baseline, every 3 months for 1 year, every 6 months up to 24 months, then annually up to 5 years.
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.
International Prostate Symptom Score (IPSS)
Time frame · Baseline, every 3 months for 1 year, every 6 months up to 24 months, then annually up to 5 years.
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.
Functional Assessment of Cancer Therapy - Prostate (FACT-P)
Time frame · Baseline, every 3 months for 1 year, every 6 months up to 24 months, then annually up to 5 years.
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.
Eligibility
Inclusion Criteria: * 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. Exclusion Criteria: * 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).
Study locations
Canada. Showing up to 24 locations stored in the fast local snapshot.
Gatineau Hospital
Gatineau, Quebec, Canada
Hôpital Général Juif
Montreal, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
CHU de Québec-Université Laval
Québec, Quebec, Canada
Publications
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