Recruiting
Phase 2

Prostate Radiotherapy

Sponsor:

University Health Network, Toronto

Code:

NCT05656794

Conditions

Prostate Metastases

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Radiotherapy

Study Details

Brief summary:

This is a prospective, randomized phase II trial investigating if radiation treatment delivered every other day for 2 weeks has the same side effects as radiation treatment delivered once weekly for 6 weeks.

Conditions

Prostate Metastases

Study ID

NCT05656794

Start date

Aug 9, 2023

Status verified date

Mar, 2026

Completion date

Aug, 2031

Anticipated

Primary completion date

Aug, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Histologically-proven prostate cancer
  • Presence of low-volume or high-volume metastases (high volume defined as the presence of visceral metastases or ≥4 bone lesions with at least 1 lesion beyond the vertebral bodies and pelvis.)
  • Planned to or receiving systemic treatment ADT +/- ARAT as per physician discretion (Previous chemotherapy allowed if completed more than 6 weeks prior to randomization.)
  • Planned for EBRT
  • ECOG 0 or 1
  • Age 18 years or older

Exclusion Criteria:

  • Prior radiotherapy to pelvis
  • Active ulcerative colitis or Crohn's Disease, at discretion of treating physician
  • Any condition where radiotherapy is contraindicated

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm 1 - Investigational

Radiation treatment (36 Gy in 6 fractions) to be delivered every other day over 2 weeks (excluding weekends).

other: Arm 2 - Standard

Radiation treatment (36 Gy in 6 fractions) to be delivered once a week over 6 weeks.

Interventions

Radiotherapy

Standard of care radiotherapy administered as per institutional guidelines.

Primary outcome measure

  • Rates of acute toxicity [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Peter Chung, MD

416-946-4501peter.chung@rmp.uhn.ca

Locations

University Health Network, Princess Margaret Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Peter Chung, MD

416-946-4501peter.chung@uhn.ca

Principal Investigator:

Peter Chung, MD

More Information

Sponsor

University Health Network, Toronto

Last update posted

Mar 23, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-03-23.