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

About This Trial

This study is for men with advanced prostate cancer that has spread to other areas of the body, but is currently responding well to standard hormone treatments.
Researchers are testing whether adding targeted radiation therapy directly to the spots where the cancer has spread works better than medication alone.
The goal is to see if treating these spots can lower cancer markers in the blood even further and keep the disease from growing.
Before deciding to join, you should know that you will be randomly assigned to either receive this extra radiation or continue with standard care alone, and additional imaging scans may be needed to track your response.

More Information

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.

Who Can Enroll

Gender: Male
Who This Trial is For: This study is for men with advanced prostate cancer that has spread to other areas of the body, but is currently responding well to standard hormone treatments.

Study Details

Start Date: December 30, 2022
Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Full Eligibility Criteria

Inclusion Criteria

Enrolled in PERa (CHUM CER 17.032) and randomly selected for ANCHOR-Prostate.
Diagnosis of hormone-sensitive metastatic prostate cancer having responded to systemic therapy.
PSA non-progressing
ECOG 0-2
Metastatic disease suitable for MDRT.
Primary tumor must have received definitive local treatment (surgery or radiotherapy) with no evidence of local recurrence, or be planned for treatment at the time of MDRT.

Exclusion Criteria