Recruiting
Phase 2

Ultrahypofractionated & Moderately Hypofractionated

Sponsor:

University Health Network, Toronto

Code:

NCT06409910

Conditions

Post-Operative Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Radiotherapy

Study Details

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.

Conditions

Post-Operative Prostate Cancer

Study ID

NCT06409910

Start date

Nov 26, 2024

Status verified date

Oct, 2026

Completion date

Nov, 2030

Anticipated

Primary completion date

Nov, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

204 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Radiotherapy

Non-institutional-standard radiotherapy

Primary outcome measure

  • Rates of Acute Toxicity [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Andrew McPartlin, MBChB

416-946-4501andrew.mcpartlin@uhn.ca

Locations

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5W9

Contacts

Joelle Helou, MD

519-685-8650joelle.helou@lhsc.on.ca

Sunnybrook Health Sciences Centre - Sunnybrook Research Institute

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Chia-Lin Tseng

416-480-4998chia-lin.tseng@sunnybrook.ca

Principal Investigator:

Chia-Lin Tseng

University Health Network - Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2C1

Contacts

Andrew McPartlin

416-946-4501andrew.mcpartlin@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Oct 8, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-10-08. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.