Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 4:22 AM
Study NCT ID:
NCT07483658
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-19
First Post:
2026-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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.
Sponsor:
CHU de Quebec-Universite Laval
Organization:
Study Overview
Official Title:
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:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HYP-OP-RT
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| PCS XIII | OTHER | Groupe d'Étude en Oncologie du Québec | View |