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

Centre hospitalier de l'Université de Montréal (CHUM)

Status and phase: Enrolling; Phase 2

Conditions: Prostate Cancer Metastatic

Treatments: Other: no RT; Radiation: SABR

Study type: Interventional

Funder types: Other

Identifiers

NCT05457699

22.115

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: Male

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

SABR consolidation

Experimental group

Treatment:

Radiation: SABR

Control - no SABR consolidation

Active Comparator group

Treatment:

Other: no RT