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Clinical Trial NCT06409910 (AMPORA) for Post-Operative Prostate Cancer is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Comparing Moderately Ultra Hypofractionated Radiation Treatments for Prostate Cancer (AMPORA) Phase 2 204 Randomized

Recruiting
Clinical Trial NCT06409910 (AMPORA) is designed to study Treatment for Post-Operative Prostate Cancer. It is a Phase 2 interventional study that is recruiting, having started on 26 November 2024, with plans to enroll 204 participants. Led by University Health Network, Toronto, it is expected to complete by 1 November 2030. The latest data from ClinicalTrials.gov was last updated on 23 March 2026.
Brief 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 5 fractions to pelvic lymph nodes delivered on alternate days.
Official Title

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

Conditions
Post-Operative Prostate Cancer
Other Study IDs
  • AMPORA
  • 23-5813
NCT ID Number
NCT06409910
Start Date (Actual)
2024-11-26
Last Update Posted
2026-03-23
Completion Date (Estimated)
2030-11
Enrollment (Estimated)
204
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalArm 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.
Radiotherapy
Non-institutional-standard radiotherapy
ExperimentalArm 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.
Radiotherapy
Non-institutional-standard radiotherapy
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Rates of Acute Toxicity
Acute grade ≥2 gastrointestinal toxicity (CTCAE v5.0)
2 years
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Rates of Acute and Late Toxicity
Acute grade ≥2 genitourinary toxicity (CTCAE v5.0)
2 years
Quality of Life Outcomes
EPIC-26 Questionnaire
2 years
Quality of Life Outcomes
IPSS Questionnaire
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
2 years
Disease Control Rate
Radiographic and/or histopathological disease control rate
2 years
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Male
  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

  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.
University Health Network, Toronto logoUniversity Health Network, Toronto
TOLMAR PHARMACEUTIQUES CANADA, INC. logoTOLMAR PHARMACEUTIQUES CANADA, INC.
Study Central Contact
Contact: Andrew McPartlin, MBChB, 416-946-4501, [email protected]
2 Study Locations in 1 Countries

Ontario

London Health Sciences Centre, London, Ontario, N6A 5W9, Canada
Joelle Helou, MD, Contact, 519-685-8650, [email protected]
Recruiting
University Health Network - Princess Margaret Cancer Centre, Toronto, Ontario, M5G 2C1, Canada
Andrew McPartlin, Contact, 416-946-4501, [email protected]
Recruiting