Adaptive external beam radiotherapy added to Lutetium-177 PSMA therapy for metastatic castration-resistant prostate cancer
Official title: Adaptive External Beam and Radioligand Radiotherapy for MEtaSTatic Castration Resistant Prostate Cancer (ARREST): a Phase II Registry-based RCT
Run by Centre hospitalier de l'Université de Montréal (CHUM) · NCT07354594 · Data updated 2026-11-12
This trial tests whether adding targeted external beam radiotherapy during Lutetium-177 PSMA treatment can improve outcomes for men with metastatic castration‑resistant prostate cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Sex | Men only |
| Enrollment | 120 (estimated) |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Montreal, Quebec) |
| Status | Recruiting |
| Started | July 7, 2026 |
| Main results expected | May 2028 |
| Study ends | May 2028 |
| Registry record updated | September 1, 2026 |
| Trial ID | NCT07354594 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with metastatic castration-resistant prostate cancer who are receiving 177Lu-PSMA and have measurable metastases suitable for EBRT, with ECOG 0–1.
✕Probably not a fit
Patients without measurable metastases or those unlikely to tolerate additional EBRT may not benefit from this combined approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pragmatic, registry-based phase 2 study compares standard 177Lu-PSMA therapy with an added adaptive external beam radiotherapy (EBRT) approach in men with metastatic castration-resistant prostate cancer. EBRT is delivered between cycles of radioligand treatment to boost underdosed metastatic sites while maintaining overall safety. The trial is multi-center and randomized, aiming to see if the combined approach reduces skeletal-related events without increasing toxicity. Eligible patients have measurable metastases suitable for EBRT and are receiving 177Lu-PSMA, with good performance status. Outcomes will inform whether adaptive EBRT can enhance the effectiveness of PSMA-targeted radioligand therapy.
Why it matters
Potential benefit: If successful, patients could experience better control of metastatic lesions and fewer skeletal-related events while staying on PSMA-targeted therapy.
How similar studies have gone: Previous PSMA therapies have shown benefit; adding adaptive EBRT to radioligand therapy is a novel approach with promising rationale but requires confirmation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Receiving 177Lu-PSMA for mCRPC * ECOG 0-1 * Presence of a discernible metastatic burden suitable for EBRT * Receiving bone protective therapy Exclusion Criteria: * no exclusions
Where it's running
-
Centre Hospitalier de l'Université-de-Montréal
Montreal, Quebec, Canada Recruiting
Study contacts
- Principal investigator: Cynthia Menard, MD — Centre hospitalier de l'Université de Montréal (CHUM)
- Study coordinator: Mom Phat
- Email: mom.phat.chum@ssss.gouv.qc.ca
- Phone: 514-890-8000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.