Neoadjuvant Androgen Deprivation Therapy Plus Abiraterone With or Without Apalutamide for High-Risk Prostate Cancer

Phase 2 Completed 64 enrolled Cancer Institute of the State of São Paulo Janssen, LP · collab

RandomizedParallel-groupSingle-blindTreatment

Summary

This is a randomized study to evaluate the efficacy and safety neoadjuvant androgen deprivation therapy with goserelin and abiraterone with or without apalutamide prior to radical prostatectomy for patients diagnosed with localized high-risk prostate cancer.

Timeline

Start: 2019-01-24
Primary completion: 2022-04-30
Completion: 2022-08-01

Publications

Nascimento BCG, Pedrenho R, Zandona PCE, Sanvido LV, Bessa Junior J, Miranda EP, Bastos DA, Cordeiro MD, Coelho R, Nahas WC, Hallak J, Mulhall JP, Gomes CM. Prospective study of endogenous testosterone recovery following neoadjuvant hormonal blockade and radical prostatectomy in high-risk prostate cancer patients. J Sex Med. 2025 Sep 4;22(9):1554-1563. doi: 10.1093/jsxmed/qdaf164.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Apalutamide	Small molecule	240 mg	Oral
Background	Abiraterone acetate	Small molecule	1000 mg	Oral
Background	Goserelin	Other / unclassified	10.8 mg	Subcutaneous
Background	Prednisone	Other / unclassified	5 mg	Oral

Neoadjuvant Androgen Deprivation Therapy Plus Abiraterone With or Without Apalutamide for High-Risk Prostate Cancer

Summary

Timeline

Publications

Drugs

Indications