Consolidative Prostate Radiotherapy in Metastatic Prostate Cancer (CONSORT-PC)

March 18, 2026 updated by: University Health Network, Toronto

Consolidative Prostate Radiotherapy in Patients With Metastatic Prostate Cancer

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • University Health Network, Princess Margaret Hospital
        • Principal Investigator:
          • Peter Chung, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1 - Investigational
Radiation treatment (36 Gy in 6 fractions) to be delivered every other day over 2 weeks (excluding weekends).
Radiation: Radiotherapy
Standard of care radiotherapy administered as per institutional guidelines.
Other: Arm 2 - Standard
Radiation treatment (36 Gy in 6 fractions) to be delivered once a week over 6 weeks.
Radiation: Radiotherapy
Standard of care radiotherapy administered as per institutional guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure failure-free survival
Time Frame: 5 years
Compare failure-free survival, collected through medical records, for participants in Arm 1 and Arm 2
5 years
Rates of late toxicity.
Time Frame: 5 years
Compare rates of late toxicity between participants in Arm 1 and Arm 2. Late toxicity will be measured using CTCAE V5.0
5 years
Quality of Life Outcomes
Time Frame: 5 years
EPIC-26 Questionnaire
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

TerSera Therapeutics LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 9, 2023

Primary Completion (Estimated)

August 1, 2031

Study Completion (Estimated)

August 1, 2031

Study Registration Dates

First Submitted

December 9, 2022

First Submitted That Met QC Criteria

December 9, 2022

First Posted (Actual)

December 19, 2022

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-5921

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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