Consolidative Prostate Radiotherapy in Patients With Metastatic Prostate Cancer

University Health Network, Toronto1 site in 1 country40 target enrollmentAugust 9, 2023

ConditionsProstate Metastases

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Prostate Metastases
Sponsor: University Health Network, Toronto
Enrollment: 40
Locations: 1
Primary Endpoint: Rates of acute toxicity
Status: Recruiting
Last Updated: last month

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 9, 2023

End Date

August 1, 2031

Last Updated

last month

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

University Health Network, Toronto

Responsible Party

Sponsor

Eligibility Criteria

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