NCT05457699 Ablative Radiotherapy to Consolidate Maximal Systemic Response in Metastatic Prostate Cancer (ANCHOR-Prostate)
| NCT ID | NCT05457699 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) |
| Condition | Prostate Cancer Metastatic |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2022-12-30 |
| Primary Completion | 2030-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 80 participants in total. It began in 2022-12-30 with a primary completion date of 2030-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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: * Planned intermittent systemic therapy. * Planned radio-ligand therapy.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05457699 clinical trial?
This trial is open to male participants only, studying Prostate Cancer Metastatic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05457699 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05457699 currently recruiting?
Yes, NCT05457699 is actively recruiting participants. Contact the research team at mom.phat.chum@ssss.gouv.qc.ca for enrollment information.
Where is the NCT05457699 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT05457699 clinical trial?
NCT05457699 is sponsored by Centre hospitalier de l'Université de Montréal (CHUM). The trial plans to enroll 80 participants.
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