drugset / Trial / NCT04181203

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

NCT04181203

Phase 3 Active not recruiting 490 enrolled UNICANCER Janssen Pharmaceutica · collab
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2020-01-09
Primary completion
2028-09-28
Completion
2033-12-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Apalutamide Small molecule 240 mg Oral
Background Goserelin Other / unclassified
Background Leuprolide Other / unclassified
Background Triptorelin Other / unclassified

Indications