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NCT05457699 Clinical Trial

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

Prostate Cancer Metastatic Clinical Trial

— ANCHORProstate  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05457699
Other study ID #
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date December 30, 2022
Est. completion date July 30, 2030

Study information
Verified date February 2024
Source Centre hospitalier de l'Université de Montréal (CHUM)
Contact Mom Phat
Phone 514-890-8254
Email mom.phat.chum@ssss.gouv.qc.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 80
Est. completion date July 30, 2030
Est. primary completion date July 30, 2025
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Radiation:
• SABR
SBAR to PSMA-PET visible disease at maximal systemic therapy response.
Other:
• no RT
no SABR, continued systemic therapy per SOC

Locations
Country Name City State
Canada CRCHUM Montreal Quebec

Sponsors (1)
Lead Sponsor Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary FFS FFS is defined as time from randomization to the first of the following events: PSA progression, radiographic or clinical progression. 1 year
Secondary HRQoL 5 years
Secondary Toxicity CTCAEv5, incidence rate 5 years
Secondary Time to progression 5 years
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