Prostatectomy Clinical Trials

Clinical trials related to Prostatectomy Procedure

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)

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
Gatineau Hospital
NOT_YET_RECRUITING
Gatineau
Hôpital Général Juif
NOT_YET_RECRUITING
Montreal
McGill University Health Centre
NOT_YET_RECRUITING
Montreal
CHU de Québec-Université Laval
RECRUITING
Québec
Contact Information
Primary
Eric Vigneault, MD, MSc
eric.vigneault.med@ssss.gouv.qc.ca
418 691-5264
Backup
Damien Carignan, PhD
damien.carignan@crchudequebec.ulaval.ca
418 525-4444
Time Frame
Start Date: 2026-05-13
Estimated Completion Date: 2036-02
Participants
Target number of participants: 434
Treatments
Active_comparator: Arm A
Prostate bed 62.5 Gy / 25 Pelvis 45 Gy / 25 (+/-55 Gy/25) ADT
Experimental: Arm B
Prostate bed 52.5 Gy / 20 Pelvis 43 Gy / 20 (+/-52 Gy/20) ADT
Related Therapeutic Areas
Sponsors
Collaborators: TerSera Therapeutics LLC
Leads: CHU de Quebec-Universite Laval

This content was sourced from clinicaltrials.gov

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