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CONSORT-PC: Consolidative Prostate Radiotherapy in Metastatic Prostate Cancer

Sponsor
University Health Network, Toronto (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05656794
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
96
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Radiotherapy
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Consolidative Prostate Radiotherapy in Patients With Metastatic Prostate Cancer
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2031
Anticipated Study Completion Date :
Mar 1, 2031

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Rates of acute toxicity [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 Outcome Measures

  1. Rates of late toxicity. [5 years]

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

  2. Measure failure-free survival [5 years]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Histologically-proven metastatic 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.)

  • Receiving systemic treatment ADT +/- ARAT (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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Health Network, Princess Margaret Hospital Toronto Ontario Canada M5G 2M9

Sponsors and Collaborators

  • University Health Network, Toronto

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT05656794
Other Study ID Numbers:
  • 22-5921
First Posted:
Dec 19, 2022
Last Update Posted:
Dec 19, 2022
Last Verified:
Dec 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

No Results Posted as of Dec 19, 2022