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

NCT ID: NCT05457699

Last Updated: 2025-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-30

Study Completion Date

2030-07-30

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer Metastatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SABR consolidation

Group Type EXPERIMENTAL

SABR

Intervention Type RADIATION

SBAR to PSMA-PET visible disease at maximal systemic therapy response.

Control - no SABR consolidation

Group Type ACTIVE_COMPARATOR

no RT

Intervention Type OTHER

no SABR, continued systemic therapy per SOC

Interventions

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SABR

SBAR to PSMA-PET visible disease at maximal systemic therapy response.

Intervention Type RADIATION

no RT

no SABR, continued systemic therapy per SOC

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CRCHUM

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Mom Phat

Role: CONTACT

514-890-8254

Facility Contacts

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Mom Phat

Role: primary

514-890-8254

Other Identifiers

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22.115

Identifier Type: -

Identifier Source: org_study_id

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