MedTrace Logo

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

NCT05457699 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-04-08

No results posted yet for this study

Summary

This will be a pragmatic, phase II, registry-based cohort-multiple randomized controlled trial (cmRCT) embedded within an ongoing prospective cancer radiotherapy registry. Eligible patients are those with hormone-sensitive metastatic prostate cancer who have responded to systemic therapy, defined by the absence of PSA progression, and who are eligible for MDRT. All eligible subjects will be enrolled into the registry and followed longitudinally for oncologic and toxicity outcomes.

From this registry, patients will be randomly selected (1:1) to be offered the experimental arm, which consists of MDRT delivered to metastatic sites identified on imaging in patients who have already initiated systemic therapy (Figure 1). Those not selected will continue to receive standard of care systemic therapy +/- standard of care radiotherapy if clinically indicated. Nor patients or physicians will be blinded.

Following the initial course of MDRT, prostate-specific antigen (PSA) will be measured, with a minimum assessment at 3 months. This PSA value will be used to determine whether the PSA level has decreased below 0.2 ng/mL. If the PSA remains ≥ 0.2 ng/mL, repeat PSMA-PET will be performed, and a second course of MDRT will be delivered to consolidate residual metastatic lesions.

In this phase II real-world randomized trial, we will determine if AnChoRing (Addition of MDRT for consolidation of response) sites of PSMA PET visible disease when responding to systemic therapy improves the proportion of patients achieving a PSA \< 0.2 ng/mL and extends failure-free survival compared to the standard of care.

Conditions

  • Prostate Cancer Metastatic

Interventions

RADIATION

Metastasis directed radiotherapy (MDRT)

MDRT to PSMA-PET visible disease at systemic therapy response.

OTHER

no MDRT

Continue systemic therapy per standard of care

Sponsors & Collaborators

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-30
Primary Completion
2030-07-30
Completion
2030-07-30

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05457699 on ClinicalTrials.gov