Comparing Moderately Ultra Hypofractionated Radiation Treatments for Prostate Cancer

NCT06409910 | Recruiting Phase 2

• 1 other identifier: 23-5813
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Rates of Acute Toxicity

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

  2 years

Secondary Outcomes (5)

• Rates of Acute and Late Toxicity

  2 years

• Quality of Life Outcomes

  2 years

• Quality of Life Outcomes

  2 years

• Biochemical disease-free survival

  2 years

• Disease Control Rate

  2 years

Study Arms (2)

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.

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.

Radiation: Radiotherapy

Interventions

Radiotherapy RADIATION

Non-institutional-standard radiotherapy

Arm 1: Moderately Hypofractionated Radiotherapy; Arm 2: Ultrahypofractionated Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• TOLMAR PHARMACEUTIQUES CANADA, INC.: collaborator

Study Sites (2)

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

RECRUITING

University Health Network - Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2C1, Canada

RECRUITING

MeSH Terms

Interventions

Radiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Andrew McPartlin, MBChB

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: May 10, 2024
• Study Start: November 26, 2024
• Primary Completion (Estimated): November 1, 2030
• Study Completion (Estimated): November 1, 2030
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

CA (2)