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Recruiting

NCT Number: NCT06409910

Comparing Moderately Ultra Hypofractionated Radiation Treatments for Prostate Cancer

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.

Recruiting

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Key information

Conditions

Post-Operative Prostate Cancer

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

London Health Sciences Centre, London, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Radiotherapy

Radiation

Non-institutional-standard radiotherapy

Primary outcomes

  1. Rates of Acute Toxicity

    Time frame: 2 years

    Acute grade ≥2 gastrointestinal toxicity (CTCAE v5.0)

Secondary outcomes

  1. Rates of Acute and Late Toxicity

    Time frame: 2 years

    Acute grade ≥2 genitourinary toxicity (CTCAE v5.0)

  2. Quality of Life Outcomes

    Time frame: 2 years

    EPIC-26 Questionnaire

  3. Quality of Life Outcomes

    Time frame: 2 years

    IPSS Questionnaire

  4. 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

  5. Disease Control Rate

    Time frame: 2 years

    Radiographic and/or histopathological disease control rate

Study contacts

Contact information is provided by the study sponsor or research team.

Andrew McPartlin, MBChB

CONTACT

[email protected]

416-946-4501 ext. 4855

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • TOLMAR PHARMACEUTIQUES CANADA, INC.

Registry information

Official study title

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

Acronym: AMPORA

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
May 10, 2024
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.