About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
Prior pelvic radiotherapy.
Macroscopic local relapse on imaging
Presence of metastatic disease.
Active inflammatory bowel disease or other GI conditions predisposing to radiation toxicity.
Trial design
Treatments tested in this trial
- Standard Fractionation Post-Operative Salvage Radiotherapy (25 fractions)
- Hypofractionated Post-Operative Salvage Radiotherapy (20 fractions)
- Androgen Deprivation Therapy (ADT)
Treatment groups
Locations
4Sponsors and collaborators
CHU de Quebec-Universite Laval
Lead sponsor
TerSera Therapeutics LLC
Collaborator