An interventional study of Standard Fractionation Post-Operative Salvage Radiotherapy (25 fractions) and Hypofractionated Post-Operative Salvage Radiotherapy (20 fractions) in Reccurent/Metastatic Solid Tumor Disease, Prostate Cancer (Post Prostatectomy) and Prostate Cancer, sponsored by CHU de Quebec-Universite Laval. Recruiting at 4 sites in Canada. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by CHU de Quebec-Universite Laval · Not applicable, Interventional, and Treatment
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
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 434 is above the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →CHU de Quebec-Universite Laval is the lead sponsor of 137 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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)
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
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
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.
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.
Time frame: Within 24 months after completion of radiotherapy.
Biochemical Progression-Free Survival (bPFS)
Time from the end of radiotherapy to biochemical recurrence, defined as PSA ≥ 0.2 ng/mL and rising.
Time frame: Up to 10 years post-treatment.
Progression-Free Survival (PFS)
Time from the end of radiotherapy to biochemical recurrence, metastatic recurrence, or death from any cause, whichever occurs first.
Time frame: Up to 10 years post-treatment.
Metastasis-Free Survival (MFS)
Time from the end of radiotherapy to the first occurrence of metastatic disease or death from any cause.
Time frame: Up to 10 years post-treatment.
Time to Initiation of Systemic Salvage Therapy
Time from the end of radiotherapy to the start of systemic therapy (e.g., ADT, ARPis, chemotherapy).
Time frame: Up to 10 years post-treatment.
Overall Survival (OS)
Time from the end of radiotherapy to death from any cause.
Time frame: Up to 10 years post-treatment.
Expanded Prostate Cancer Index Composite-26 (EPIC-26)
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.
Time frame: 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)
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.
Time frame: 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)
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.
Time frame: Baseline, every 3 months for 1 year, every 6 months up to 24 months, then annually up to 5 years.
Plan to share: No — Institutional policies are against sharing IPD.
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