Consolidative Prostate Radiotherapy in Metastatic Prostate Cancer

Phase 2RecruitingNCT05656794

University Health Network, Toronto40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Metastases

Interventions

RadiotherapyRADIATION

Standard of care radiotherapy administered as per institutional guidelines.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (1)

University Health Network, Princess Margaret Hospital

Toronto, Ontario, Canada

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 5 years

Secondary Outcomes

Rates of late toxicity.

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

Time frame: 5 years

Measure failure-free survival

Compare failure-free survival, collected through medical records, for participants in Arm 1 and Arm 2

Time frame: 5 years

Quality of Life Outcomes

EPIC-26 Questionnaire

Time frame: 5 years

Central Contacts

Peter Chung, MD

CONTACT

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

Data from ClinicalTrials.gov

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