Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05656794

Consolidative Prostate Radiotherapy in 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Prostate Metastases

Age range

18 year–100 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

University Health Network, Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location status: Recruiting

Location contact

Peter Chung, MD

CONTACT

[email protected]

416-946-4501 ext. 2126

Peter Chung, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiotherapy

Radiation

Standard of care radiotherapy administered as per institutional guidelines.

Primary outcomes

  1. 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

  1. 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

  2. Measure failure-free survival

    Time frame: 5 years

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

  3. Quality of Life Outcomes

    Time frame: 5 years

    EPIC-26 Questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Peter Chung, MD

CONTACT

[email protected]

416-946-4501 ext. 2126

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • TerSera Therapeutics LLC

Registry information

Official study title

Consolidative Prostate Radiotherapy in Patients With Metastatic Prostate Cancer

Acronym: CONSORT-PC

Important dates

Study start
2023
Primary completion
2031
Study completion
2031
First posted
Dec 19, 2022
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.