Recruiting

SRT Comparison

Sponsor:

CHU de Quebec-Universite Laval

Code:

NCT07483658

Conditions

Reccurent/Metastatic Solid Tumor Disease

Prostate Cancer (Post Prostatectomy)

Prostate Cancer

Prostatic Neoplasms

Neoplasm Recurrence, Local

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Standard Fractionation Post-Operative Salvage Radiotherapy (25 fractions)

Hypofractionated Post-Operative Salvage Radiotherapy (20 fractions)

Androgen Deprivation Therapy (ADT)

Study Details

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

Conditions

Reccurent/Metastatic Solid Tumor Disease

Prostate Cancer (Post Prostatectomy)

Prostate Cancer

Prostatic Neoplasms

Neoplasm Recurrence, Local

Study ID

NCT07483658

Start date

May 13, 2026

Status verified date

Jun, 2026

Completion date

Feb, 2036

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

434 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

Standard Fractionation Post-Operative Salvage Radiotherapy (25 fractions)

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

Hypofractionated Post-Operative Salvage Radiotherapy (20 fractions)

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

Androgen Deprivation Therapy (ADT)

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.

Primary outcome measure

  • Incidence of Grade 2 or Higher Genitourinary (GU) or Gastrointestinal (GI) Toxicity [ Time Frame: Within 24 months after completion of radiotherapy. ]

Central Contacts and Locations

Central contacts

Eric Vigneault, MD, MSc

418 691-5264eric.vigneault.med@ssss.gouv.qc.ca

Damien Carignan, PhD

418 525-4444damien.carignan@crchudequebec.ulaval.ca

Locations

CHU de Québec-Université Laval

Recruiting

Québec, Quebec, Canada, G1G 5X1

Contacts

Eric Vigneault, MD, MSc

418 691-5264eric.vigneault.med@ssss.gouv.qc.ca

Damien Carignan, PhD

418 525-4444damien.carignan@crchudequebec.ulaval.ca

More Information

Sponsor

CHU de Quebec-Universite Laval

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Keywords

  • Radiotherapy, Adjuvant
  • Radiotherapy, Intensity-Modulated
  • Radiotherapy, High-Dose Hypofractionated
  • Pelvic Radiotherapy
  • Androgen Deprivation Therapy
  • Randomized Controlled Trials
  • Noninferiority Trials
  • Quality of Life
  • Treatment Outcome
  • Gastrointestinal Diseases / chemically induced
  • Urinary Tract Diseases / chemically induced
  • Radiation Injuries

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-16. This information was provided to ClinicalTrials.gov by CHU de Quebec-Universite Laval on 2026-07-01.