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NCT06654336 · ClinicalTrials.gov record · last posted 2026-03-13

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)

Study acronym: RATIONAL
StatusRecruiting
PhasePhase 2
Started2026-03-30
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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.

Amendment record 5 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 5 times since 2024-10-22; most recent amendment 2026-03-11. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2026-03-11
Status change Not Yet Recruiting→Recruitingv5
Trial Details
NCT Number NCT06654336
Lead Sponsor Ontario Clinical Oncology Group (OCOG)
Conditions Prostate Adenocarcinoma, Castration Sensitive Prostate Cancer
Enrollment 162 participants
Start Date 2026-03-30
Primary Completion 2031-04 (estimated)
Study Completion 2031-06 (estimated)
Updated on ClinicalTrials.gov 2026-03-13