Clincosm LogoSign in Get a demo

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

Sponsor
Centre hospitalier de l'Université de Montréal (CHUM) (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05457699
Collaborator
(none)
80
Enrollment
2
Arms
96
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: SABR
  • Other: no RT
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Ablative Radiotherapy to Consolidate Maximal Systemic Response in Metastatic Prostate Cancer (ANCHOR-Prostate)
Anticipated Study Start Date :
Jul 30, 2022
Anticipated Primary Completion Date :
Jul 30, 2025
Anticipated Study Completion Date :
Jul 30, 2030

Arms and Interventions

Arm Intervention/Treatment
Experimental: SABR consolidation

Radiation: SABR
SBAR to PSMA-PET visible disease at maximal systemic therapy response.
Active Comparator: Control - no SABR consolidation

Other: no RT
no SABR, continued systemic therapy per SOC

Outcome Measures

Primary Outcome Measures

  1. FFS [1 year]

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

Secondary Outcome Measures

  1. HRQoL [5 years]

  2. Toxicity [5 years]

    CTCAEv5, incidence rate

  3. Time to progression [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Centre hospitalier de l'Université de Montréal (CHUM)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT05457699
Other Study ID Numbers:
    First Posted:
    Jul 14, 2022
    Last Update Posted:
    Jul 14, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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 Jul 14, 2022