drugset / Trial / NCT06654336

Study of Recurrence-directed Therapy (RDT) With or Without Androgen-Deprivation Therapy (ADT) In Patients With Radio-recurrent Oligo-metastatic Hormone/Castrate Sensitive Prostate Cancer (romCSPC)

NCT06654336

Phase 2 Recruiting 162 enrolled Ontario Clinical Oncology Group (OCOG)
RandomizedParallel-groupOpen-labelTreatment

Summary

The goal of this study is to determine whether the addition of Androgen Deprivation Therapy (ADT) utilizing the study drug ELIGARD® to Recurrence- Directed Therapy (RDT) improves progression-free survival (PFS) compared to RDT alone in patients with early radio-recurrent oligo-metastatic castrate / hormone sensitive prostate cancer (romCSPC). Participants will be assessed at standard of care clinic visits every 3 months. The follow-up period is 36 months.

Timeline

Start
2026-03-30
Primary completion
2031-04
Completion
2031-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Leuprolide Other / unclassified 22.5 mg