Clinical Trial

Combined Apalutamide, Radiotherapy, and LHRH Agonist in Prostate Cancer Patients After Prostatectomy

Study acronym: CARLHA-2
Active, Not Recruiting Phase 3
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Summary
This is a multicenter, randomized, open label, phase III study comparing the efficacy and safety of apatulamide combined with concomitant prostate-bed salvage radiotherapy (SRT) and androgen deprivation therapy (ADT) versus concomitant prostate-bed SRT and ADT in high-risk postprostatectomy biochemically relapsed prostate cancer patients.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2019-11-26; most recent amendment 2025-07-29.
Status change: Recruiting → Active, Not Recruiting 2025-07-29
Status change: Suspended → Recruiting 2020-09-22
Status change: Recruiting → Suspended 2020-04-22
Status change: Not Yet Recruiting → Recruiting 2020-01-24
Trial Details
NCT Number NCT04181203
Lead Sponsor UNICANCER
Collaborators: Janssen Pharmaceutica
Conditions Prostate Cancer
Enrollment 490 participants
Start Date 2020-01-09
Primary Completion 2028-09-28 (estimated)
Study Completion 2033-12-28 (estimated)
Updated on ClinicalTrials.gov 2025-07-30