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Clinical Trials/NCT05656794
NCT05656794RecruitingPhase 2

Consolidative Prostate Radiotherapy in Patients With Metastatic Prostate Cancer

University Health Network, Toronto1 site in 1 country40 target enrollmentStarted: August 9, 2023Last updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Status
Recruiting
Enrollment
40
Locations
1
Primary Endpoint
Rates of acute toxicity
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 100 Years (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Rates of acute toxicity

Time Frame: 5 years

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

Secondary Outcomes

  • Measure failure-free survival(5 years)
  • Rates of late toxicity.(5 years)
  • Quality of Life Outcomes(5 years)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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