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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 August 9, 2023, with plans to enroll 40 participants. Led by University Health Network, Toronto, it is expected to complete by August 1, 2031. The latest data from ClinicalTrials.gov was last updated on March 23, 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