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. (HYP-OP-RT)

March 16, 2026 updated by: CHU de Quebec-Universite Laval

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)

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

434

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm A
Prostate bed 62.5 Gy / 25 Pelvis 45 Gy / 25 (+/-55 Gy/25) ADT
Radiation: 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

Drug: 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.
Experimental: Arm B
Prostate bed 52.5 Gy / 20 Pelvis 43 Gy / 20 (+/-52 Gy/20) ADT
Drug: 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.

Radiation: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Grade 2 or Higher Genitourinary (GU) or Gastrointestinal (GI) Toxicity
Time Frame: Within 24 months after completion of radiotherapy.
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.
Within 24 months after completion of radiotherapy.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemical Progression-Free Survival (bPFS)
Time Frame: Up to 10 years post-treatment.
Time from the end of radiotherapy to biochemical recurrence, defined as PSA ≥ 0.2 ng/mL and rising.
Up to 10 years post-treatment.
Progression-Free Survival (PFS)
Time Frame: Up to 10 years post-treatment.
Time from the end of radiotherapy to biochemical recurrence, metastatic recurrence, or death from any cause, whichever occurs first.
Up to 10 years post-treatment.
Metastasis-Free Survival (MFS)
Time Frame: Up to 10 years post-treatment.
Time from the end of radiotherapy to the first occurrence of metastatic disease or death from any cause.
Up to 10 years post-treatment.
Time to Initiation of Systemic Salvage Therapy
Time Frame: Up to 10 years post-treatment.
Time from the end of radiotherapy to the start of systemic therapy (e.g., ADT, ARPis, chemotherapy).
Up to 10 years post-treatment.
Overall Survival (OS)
Time Frame: Up to 10 years post-treatment.
Time from the end of radiotherapy to death from any cause.
Up to 10 years post-treatment.
Expanded Prostate Cancer Index Composite-26 (EPIC-26)
Time Frame: Baseline, every 3 months for 1 year, every 6 months up to 24 months, then annually up to 5 years.
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.
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)
Time Frame: Baseline, every 3 months for 1 year, every 6 months up to 24 months, then annually up to 5 years.
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.
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)
Time Frame: Baseline, every 3 months for 1 year, every 6 months up to 24 months, then annually up to 5 years.
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.
Baseline, every 3 months for 1 year, every 6 months up to 24 months, then annually up to 5 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Quebec-Universite Laval

Collaborators

TerSera Therapeutics LLC

Investigators

  • Principal Investigator: Eric Vigneault, MD, MSc, CHU de Quebec-Universite Laval

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

February 1, 2036

Study Registration Dates

First Submitted

March 13, 2026

First Submitted That Met QC Criteria

March 16, 2026

First Posted (Actual)

March 19, 2026

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP-20-2026-8430
  • PCS XIII (Other Identifier: Groupe d'Étude en Oncologie du Québec)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Institutional policies are against sharing IPD.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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