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Ablative Radiotherapy to Consolidate Maximal Systemic Response in Metastatic Prostate Cancer (ANCHOR-Prostate) (ANCHORProstate)

Primary Purpose

Prostate Cancer Metastatic

Status
Recruiting
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
SABR
no RT
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer Metastatic

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

3.1.1 Enrolled in PERa (CHUM CER 17.032) and randomly selected for AnChoR-Prostate.

3.1.2 Diagnosis of metastatic prostate cancer having achieved maximum PSA response to SOC systemic therapy defined as two consecutive stable PSA within 6 months of regimen start. Stable PSA is defined as non- progressing (<25% rise from nadir, per PCWG3 guidelines).

3.1.3 ECOG 0-2 3.1.4 PSA > 0.2 ng/mL 3.1.5 1-5 sites of PSMA-PET avid disease amenable to SABR.

Exclusion Criteria:

  • none

Sites / Locations

  • CRCHUMRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SABR consolidation

Control - no SABR consolidation

Arm Description

Outcomes

Primary Outcome Measures

FFS
FFS is defined as time from randomization to the first of the following events: PSA progression, radiographic or clinical progression.

Secondary Outcome Measures

HRQoL
Toxicity
CTCAEv5, incidence rate
Time to progression

Full Information

First Posted
July 4, 2022
Last Updated
January 31, 2023
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
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1. Study Identification

Unique Protocol Identification Number
NCT05457699
Brief Title
Ablative Radiotherapy to Consolidate Maximal Systemic Response in Metastatic Prostate Cancer (ANCHOR-Prostate)
Acronym
ANCHORProstate
Official Title
Ablative Radiotherapy to Consolidate Maximal Systemic Response in Metastatic Prostate Cancer (ANCHOR-Prostate)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 30, 2022 (Actual)
Primary Completion Date
July 30, 2025 (Anticipated)
Study Completion Date
July 30, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A phase IIR cmRCT trial companion to PERa registry, investigating the merit of SABR consolidation in men with metastatic prostate cancer. 80 patients will be randomly selected to be offered experimental SABR based on PSMA-PET detected disease after maximal systemic response. The primary endpoint is the rate of FFS at 1 year. Patients will be stratified according to hormone sensitive vs resistant disease prior to randomisation.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SABR consolidation
Arm Type
Experimental
Arm Title
Control - no SABR consolidation
Arm Type
Active Comparator
Intervention Type
Radiation
Intervention Name(s)
SABR
Intervention Description
SBAR to PSMA-PET visible disease at maximal systemic therapy response.
Intervention Type
Other
Intervention Name(s)
no RT
Intervention Description
no SABR, continued systemic therapy per SOC
Primary Outcome Measure Information:
Title
FFS
Description
FFS is defined as time from randomization to the first of the following events: PSA progression, radiographic or clinical progression.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
HRQoL
Time Frame
5 years
Title
Toxicity
Description
CTCAEv5, incidence rate
Time Frame
5 years
Title
Time to progression
Time Frame
5 years

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 3.1.1 Enrolled in PERa (CHUM CER 17.032) and randomly selected for AnChoR-Prostate. 3.1.2 Diagnosis of metastatic prostate cancer having achieved maximum PSA response to SOC systemic therapy defined as two consecutive stable PSA within 6 months of regimen start. Stable PSA is defined as non- progressing (<25% rise from nadir, per PCWG3 guidelines). 3.1.3 ECOG 0-2 3.1.4 PSA > 0.2 ng/mL 3.1.5 1-5 sites of PSMA-PET avid disease amenable to SABR. Exclusion Criteria: none
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mom Phat
Phone
514-890-8254
Email
mom.phat.chum@ssss.gouv.qc.ca
Facility Information:
Facility Name
CRCHUM
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mom Phat
Phone
514-890-8254
Email
mom.phat.chum@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name & Degree
Cynthia Menard, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Ablative Radiotherapy to Consolidate Maximal Systemic Response in Metastatic Prostate Cancer (ANCHOR-Prostate)

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