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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Trial: ALTERNATE DAY ULTRAHYPOFRACTIONATED OR DAILY MODERATELY HYPOFRACTIONATED POST OPERATIVE RADIOTHERAPY
- ClinicalTrials.gov ID
- NCT06409910
- Acronym / sponsor ID
- AMPORA / 23-5813
- Conditions
- Post-Operative Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- TOLMAR PHARMACEUTIQUES CANADA, INC.
- Study start
- 26 Nov 2024 (actual)
- Primary completion
- Nov 2030 (estimated)
- Study completion
- Nov 2030 (estimated)
- First posted
- 10 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Moderately Hypofractionated Radiotherapy | Experimental | Radiation: RadiotherapyExternal beam radiotherapy 54 Gy in 20 fractions to prostate bed +/- 44 Gy in 20 fractions to pelvic lymph nodes delivered daily. |
| Arm 2: Ultrahypofractionated Radiotherapy | Experimental | Radiation: RadiotherapyExternal beam radiotherapy 30 Gy in 5 fractions to prostate bed +/- 25 Gy in 5 fractions to pelvic lymph nodes delivered on alternate days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiotherapyNon-institutional-standard radiotherapy | Radiation | Arm 1: Moderately Hypofractionated Radiotherapy, Arm 2: Ultrahypofractionated Radiotherapy |
Primary outcome
Rates of Acute Toxicity
Time frame: 2 years
Acute grade ≥2 gastrointestinal toxicity (CTCAE v5.0)
5 secondary outcomes
Rates of Acute and Late Toxicity
Time frame: 2 years
Quality of Life Outcomes
Time frame: 2 years
Quality of Life Outcomes
Time frame: 2 years
Biochemical disease-free survival
Time frame: 2 years
Disease Control Rate
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiotherapy in people with Post-Operative Prostate Cancer, run by University Health Network, Toronto at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew McPartlin, MBChB (416-946-4501 ext. 4855, andrew.mcpartlin@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of Acute Toxicity (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.