Clinical Trial: NCT02489318
A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 3| Lead Sponsor: | Aragon Pharmaceuticals, Inc. |
| Information Provided By: | Aragon Pharmaceuticals, Inc. |
| Last Update Posted: | 2026-09-28 |
Study Overview
Brief Summary
The purpose of this study is to determine if the addition of apalutamide to ADT provides superior efficacy in improving radiographic progression-free survival (rPFS) or overall survival (OS) for participants with mHSPC.
Official Title
A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Apalutamide Plus Androgen Deprivation Therapy (ADT) Versus ADT in Subjects With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Conditions
Prostate Cancer
Intervention / Treatment
- Drug: Apalutamide
- Drug: Placebo
- Drug: Androgen Deprivation Therapy (ADT)
Other Study ID Numbers
- CR107614
- 56021927PCR3002
- 2015-000735-32
- 2015
Start Date (Actual)
2015-11-27
Primary Completion Date (Actual)
2020-09-07
Study Completion Date (Estimated)
2027-12-31
Enrollment (Actual)
1052
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Aragon Pharmaceuticals, Inc. |
| Information Provided By: | Aragon Pharmaceuticals, Inc. |
| Last Update Posted: | 2026-09-28 |
Study Overview
Brief Summary
The purpose of this study is to determine if the addition of apalutamide to ADT provides superior efficacy in improving radiographic progression-free survival (rPFS) or overall survival (OS) for participants with mHSPC.
Official Title
A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Apalutamide Plus Androgen Deprivation Therapy (ADT) Versus ADT in Subjects With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Conditions
Prostate Cancer
Intervention / Treatment
- Drug: Apalutamide
- Drug: Placebo
- Drug: Androgen Deprivation Therapy (ADT)
Other Study ID Numbers
- CR107614
- 56021927PCR3002
- 2015-000735-32
- 2015
Start Date (Actual)
2015-11-27
Primary Completion Date (Actual)
2020-09-07
Study Completion Date (Estimated)
2027-12-31
Enrollment (Actual)
1052
Study Type
Interventional
Phase
Phase 3