Post-Operative Prostate CancerPhase 2AMPORANCT06409910
Comparing Moderately and Ultra Hypofractionated Radiation Treatments for Post-operative Prostate Cancer
A Phase 2 study testing Radiotherapy in people with Post-Operative Prostate Cancer, run by University Health Network, Toronto at 3 sites in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Post-Operative Prostate Cancer
- What is being tested?
- Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 3 sitesCanada
- Study dates
- 26 Nov 2024to Nov 2030
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >/= 18 years
- Able to provide informed consent
- Histologic diagnosis of prostate adenocarcinoma
- ECOG performance status 0-1
- Previous radical prostatectomy > 6 months prior to radiotherapy start date
- Planned to receive post-operative radiation
Who cannot join
- Prior pelvic radiotherapy
- Contraindications to radiotherapy
- Confirmed metastases (if scan has been done for clinical care)
- Participants with visible disease in the prostate bed or pelvic lymph nodes on imaging are not eligible for treatment on study.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada3 sites, 3 recruiting
- Recruiting
London Health Sciences Centre
London, Ontario, N6A 5W9
Joelle Helou, MD, 519-685-8650, joelle.helou@lhsc.on.ca
- Recruiting
Sunnybrook Health Sciences Centre - Sunnybrook Research Institute
Toronto, Ontario, M4N 3M5
Chia-Lin Tseng, 416-480-4998, chia-lin.tseng@sunnybrook.ca
Chia-Lin Tseng
- Recruiting
University Health Network - Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2C1
Andrew McPartlin, 416-946-4501 ext. 4855, andrew.mcpartlin@uhn.ca
About this study
Official title: 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.
- Conditions
- Post-Operative Prostate Cancer
- Being tested
- Radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Non-institutional-standard radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Moderately Hypofractionated Radiotherapy | Experimental | External beam radiotherapy 54 Gy in 20 fractions to prostate bed +/- 44 Gy in 20 fractions to pelvic lymph nodes delivered daily. Receives: Radiation: Radiotherapy |
| Arm 2: Ultrahypofractionated Radiotherapy | Experimental | External beam radiotherapy 30 Gy in 5 fractions to prostate bed +/- 25 Gy in 5 fractions to pelvic lymph nodes delivered on alternate days. Receives: Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of Acute Toxicity
Acute grade ≥2 gastrointestinal toxicity (CTCAE v5.0)
Measured: 2 years
Secondary outcomes (5)
Rates of Acute and Late Toxicity
Acute grade ≥2 genitourinary toxicity (CTCAE v5.0)
Measured: 2 years
Quality of Life Outcomes
EPIC-26 Questionnaire
Measured: 2 years
Quality of Life Outcomes
IPSS Questionnaire
Measured: 2 years
Biochemical disease-free survival
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
Measured: 2 years
Disease Control Rate
Radiographic and/or histopathological disease control rate
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start26 Nov 2024
- Primary completionNov 2030 (estimated)
- Study completionNov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Operative Prostate CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Arm 1: External beam radiotherapy 54 Gy in 20 fractions to prostate bed +/- 44 Gy in 20 fractions to pelvic lymph nodes delivered daily. Arm 2: External beam radiotherapy 30 Gy in 5 fractions to prostate bed +/- 25 Gy in 5 fractions to pelvic lymph nodes delivered on alternate days.
- Masking
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- TOLMAR PHARMACEUTIQUES CANADA, INC.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06409910
- Sponsor's protocol ID
- 23-5813
- Acronym
- AMPORA
- Status last verified
- Oct 2026
- First submitted
- 15 Mar 2024
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No