# A Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Participants With High-Risk, Metastatic Hormone-Naive Prostate Cancer (mHNPC)

> **NCT01715285** · PHASE3 · COMPLETED · sponsor: **Janssen Research & Development, LLC** · enrollment: 1209 (actual)

## Conditions studied

- Prostate Neoplasms

## Interventions

- **DRUG:** Abiraterone acetate
- **DRUG:** Prednisone
- **OTHER:** Androgen deprivation therapy (ADT)
- **DRUG:** Abiraterone acetate Placebo
- **DRUG:** Prednisone Placebo

## Key facts

- **NCT ID:** NCT01715285
- **Lead sponsor:** Janssen Research & Development, LLC
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2013-02-12
- **Primary completion:** 2016-10-31
- **Final completion:** 2022-02-13
- **Target enrollment:** 1209 (ACTUAL)
- **Last updated:** 2025-02-04


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01715285

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01715285, "A Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Participants With High-Risk, Metastatic Hormone-Naive Prostate Cancer (mHNPC)". Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/clinical/NCT01715285. Licensed CC0.

---

*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*