NCT05656794

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
64mo left

Started Aug 2023

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress34%
Aug 2023Aug 2031

First Submitted

Initial submission to the registry

December 9, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 19, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

August 9, 2023

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2031

Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

8 years

First QC Date

December 9, 2022

Last Update Submit

March 18, 2026

Conditions

Prostate Metastases

Outcome Measures

Primary Outcomes (1)

  • Rates of acute toxicity

    Compare rates of acute toxicity between participants in Arm 1 and Arm 2. Acute toxicity will be measured using CTCAE V5.0

    5 years

Secondary Outcomes (3)

  • Rates of late toxicity.

    5 years

  • Measure failure-free survival

    5 years

  • Quality of Life Outcomes

    5 years

Study Arms (2)

Arm 1 - Investigational

EXPERIMENTAL

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

Radiation: Radiotherapy

Arm 2 - Standard

OTHER

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

Radiation: Radiotherapy

Interventions

RadiotherapyRADIATION

Standard of care radiotherapy administered as per institutional guidelines.

Arm 1 - InvestigationalArm 2 - Standard

Eligibility Criteria

Age18 Years - 100 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsProstate cancer excludes women
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network, Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

MeSH Terms

Interventions

Radiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Peter Chung, MD

CONTACT

416-946-4501peter.chung@rmp.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

Study Record Dates

First Submitted

December 9, 2022

First Posted

December 19, 2022

Study Start

August 9, 2023

Primary Completion (Estimated)

August 1, 2031

Study Completion (Estimated)

August 1, 2031

Last Updated

March 23, 2026

Record last verified: 2026-03

Locations

CA(1)