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Clinical Trial NCT05656794 (CONSORT-PC) for Prostate Metastases is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Consolidative Prostate Radiotherapy in Metastatic Prostate Cancer (CONSORT-PC) Phase 2 40 Randomized

Recruiting
Clinical Trial NCT05656794 (CONSORT-PC) is designed to study Treatment for Prostate Metastases. It is a Phase 2 interventional study that is recruiting, having started on 9 August 2023, with plans to enroll 40 participants. Led by University Health Network, Toronto, it is expected to complete by 1 August 2031. The latest data from ClinicalTrials.gov was last updated on 23 March 2026.
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.
Official Title

Consolidative Prostate Radiotherapy in Patients With Metastatic Prostate Cancer

Conditions
Prostate Metastases
Other Study IDs
  • CONSORT-PC
  • 22-5921
NCT ID Number
NCT05656794
Start Date (Actual)
2023-08-09
Last Update Posted
2026-03-23
Completion Date (Estimated)
2031-08
Enrollment (Estimated)
40
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalArm 1 - Investigational
Radiation treatment (36 Gy in 6 fractions) to be delivered every other day over 2 weeks (excluding weekends).
Radiotherapy
Standard of care radiotherapy administered as per institutional guidelines.
OtherArm 2 - Standard
Radiation treatment (36 Gy in 6 fractions) to be delivered once a week over 6 weeks.
Radiotherapy
Standard of care radiotherapy administered as per institutional guidelines.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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
5 years
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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
5 years
Measure failure-free survival
Compare failure-free survival, collected through medical records, for participants in Arm 1 and Arm 2
5 years
Quality of Life Outcomes
EPIC-26 Questionnaire
5 years
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Male
  • 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

  • Prior radiotherapy to pelvis
  • Active ulcerative colitis or Crohn's Disease, at discretion of treating physician
  • Any condition where radiotherapy is contraindicated
University Health Network, Toronto logoUniversity Health Network, Toronto
TerSera Therapeutics LLC logoTerSera Therapeutics LLC
Study Central Contact
Contact: Peter Chung, MD, 416-946-4501, [email protected]
1 Study Locations in 1 Countries

Ontario

University Health Network, Princess Margaret Hospital, Toronto, Ontario, M5G 2M9, Canada
Peter Chung, MD, Contact, 416-946-4501, [email protected]
Peter Chung, MD, Principal Investigator
Recruiting