Comparing Moderately Ultra Hypofractionated Radiation Treatments for Prostate Cancer (AMPORA)

March 18, 2026 updated by: University Health Network, Toronto

A Phase II Randomized Trial: ALTERNATE DAY ULTRAHYPOFRACTIONATED OR DAILY MODERATELY HYPOFRACTIONATED POST OPERATIVE RADIOTHERAPY

This is a multi-institution, randomized, non-inferiority Phase II trial comparing external beam radiotherapy delivered as 54 Gy in 20 fractions to prostate bed +/- 44 Gy in 20 fractions to pelvic lymph nodes delivered daily with external beam radiotherapy delivered as 30 Gy in 5 fractions to prostate bed +/- 25 Gy in 5 fractions to pelvic lymph nodes delivered on alternate days.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

204

Phase

  • Phase 2

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 Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • Recruiting
        • London Health Sciences Centre
        • Contact:
      • Toronto, Ontario, Canada, M5G 2C1
        • Recruiting
        • University Health Network - Princess Margaret Cancer Centre
        • Contact:

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:

  1. Age >/= 18 years
  2. Able to provide informed consent
  3. Histologic diagnosis of prostate adenocarcinoma
  4. ECOG performance status 0-1
  5. Previous radical prostatectomy > 6 months prior to radiotherapy start date
  6. Planned to receive post-operative radiation

Exclusion Criteria:

  1. Prior pelvic radiotherapy
  2. Contraindications to radiotherapy
  3. Confirmed metastases (if scan has been done for clinical care)
  4. Participants with visible disease in the prostate bed or pelvic lymph nodes on imaging are not eligible for treatment on study.

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
Experimental: Arm 1: Moderately Hypofractionated Radiotherapy
External beam radiotherapy 54 Gy in 20 fractions to prostate bed +/- 44 Gy in 20 fractions to pelvic lymph nodes delivered daily.
Radiation: Radiotherapy
Non-institutional-standard radiotherapy
Experimental: Arm 2: Ultrahypofractionated Radiotherapy
External beam radiotherapy 30 Gy in 5 fractions to prostate bed +/- 25 Gy in 5 fractions to pelvic lymph nodes delivered on alternate days.
Radiation: Radiotherapy
Non-institutional-standard radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of Acute Toxicity
Time Frame: 2 years
Acute grade ≥2 gastrointestinal toxicity (CTCAE v5.0)
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of Acute and Late Toxicity
Time Frame: 2 years
Acute grade ≥2 genitourinary toxicity (CTCAE v5.0)
2 years
Quality of Life Outcomes
Time Frame: 2 years
EPIC-26 Questionnaire
2 years
Quality of Life Outcomes
Time Frame: 2 years
IPSS Questionnaire
2 years
Biochemical disease-free survival
Time Frame: 2 years
Defined as survival until evidence of either biochemical progression (defined as a rise in prostate-specific antigen (PSA) ≥0.2ng/ml above the PSA nadir followed by a sequentially equal or higher value) following postoperative radiotherapy, clinical or radiological progression, initiation of non-protocol systemic therapy, or death from prostate cancer
2 years
Disease Control Rate
Time Frame: 2 years
Radiographic and/or histopathological disease control rate
2 years

Collaborators and Investigators

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

Sponsor

University Health Network, Toronto

Collaborators

TOLMAR PHARMACEUTIQUES CANADA, INC.

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 (Actual)

November 26, 2024

Primary Completion (Estimated)

November 1, 2030

Study Completion (Estimated)

November 1, 2030

Study Registration Dates

First Submitted

March 15, 2024

First Submitted That Met QC Criteria

May 7, 2024

First Posted (Actual)

May 10, 2024

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-5813

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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