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

Primary Purpose

Prostate Metastases

Status

Recruiting

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Radiotherapy

About this trial

This is an interventional treatment trial for Prostate Metastases

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

University Health Network, Princess Margaret HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Arm 1 - Investigational

Arm 2 - Standard

Arm Description

Radiation treatment (36 Gy in 6 fractions) to be delivered every other day over 2 weeks (excluding weekends).

Radiation treatment (36 Gy in 6 fractions) to be delivered once a week over 6 weeks.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Rates of late toxicity.

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

Measure failure-free survival

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

Full Information

NCT ID

NCT05656794

First Posted

December 9, 2022

Last Updated

July 31, 2023

Sponsor

University Health Network, Toronto

1. Study Identification

Unique Protocol Identification Number

NCT05656794

Brief Title

Consolidative Prostate Radiotherapy in Metastatic Prostate Cancer

Acronym

CONSORT-PC

Official Title

Consolidative Prostate Radiotherapy in Patients With Metastatic Prostate Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 31, 2023 (Actual)

Primary Completion Date

August 2031 (Anticipated)

Study Completion Date

August 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Metastases

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm 1 - Investigational

Arm Type

Experimental

Arm Description

Radiation treatment (36 Gy in 6 fractions) to be delivered every other day over 2 weeks (excluding weekends).

Arm Title

Arm 2 - Standard

Arm Type

Other

Arm Description

Radiation treatment (36 Gy in 6 fractions) to be delivered once a week over 6 weeks.

Intervention Type

Radiation

Intervention Name(s)

Radiotherapy

Intervention Description

Standard of care radiotherapy administered as per institutional guidelines.

Primary Outcome Measure Information:

Title

Rates of acute toxicity

Description

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

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Rates of late toxicity.

Description

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

Time Frame

5 years

Title

Measure failure-free survival

Description

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

Time Frame

5 years

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

Prostate cancer excludes women

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Peter Chung, MD

Phone

416-946-4501

Ext

2126

peter.chung@rmp.uhn.ca

Facility Information:

Facility Name

University Health Network, Princess Margaret Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Peter Chung, MD

Phone

416-946-4501

Ext

2126

peter.chung@uhn.ca

First Name & Middle Initial & Last Name & Degree

Peter Chung, MD

12. IPD Sharing Statement

Learn more about this trial

Consolidative Prostate Radiotherapy in Metastatic Prostate Cancer

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