clinical trial · NCT04523207
A Study of Apalutamide (Adjuvant Treatment) and Androgen Deprivation Therapy (ADT) in Participants Who Have Undergone Radical Prostatectomy (RP) for Non-metastatic Prostate Cancer and Who Are at High Risk for Metastases
Janssen Research & Development, LLC·phase2·completed·n = 108
Prostatic NeoplasmsApalutamideADTRelugolix
brief summary
Main Study: The purpose of main study is to assess if the combination of apalutamide and androgen deprivation therapy (ADT) in participants with high-risk localized prostate cancer improves the biochemical recurrence (BCR) free rate. Sub-study: The purpose of the sub-study is to assess if the co administration of apalutamide and relugolix is able to maintain castrate levels of testosterone.
started
Aug 19, 2020
primary completion
Oct 23, 2023
completion
Oct 25, 2023
last updated
Apr 21, 2026
official title
A Multi-center, Open-label, Single-arm Phase 2 Study of the Adjuvant Treatment of Apalutamide and Androgen Deprivation Therapy (ADT) in Treatment-naïve Participants Who Have Undergone Radical Prostatectomy (RP) for Non-metastatic Prostate Cancer and Who Are at High Risk for Metastases
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol