Androgen-deprivation Therapy (ADT)

DRUG4 trials

Sponsors

Samsung Medical Center, Janssen Pharmaceutical K.K., Janssen Research & Development, LLC

Conditions

Metastatic Castrate-sensitive Prostate CancerProstatic NeoplasmProstatic Neoplasms

Phase 2

An Open Label Phase II Study of Biweekly Docetaxel Plus Androgen-Deprivation Therapy in Patients With Previously-Untreated, Metastatic, Prostatic Adenocarcinoma

Samsung Medical CenterProstatic Neoplasm

Start: 2017-02-08End: 2022-06-30Updated: 2022-03-08

Phase 3

A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC

Active, not recruitingNCT05884398

Janssen Research & Development, LLCMetastatic Castrate-sensitive Prostate Cancer

Start: 2023-08-31End: 2028-10-12Updated: 2026-08-28

Phase 4

A Study of Apalutamide in Chinese Participants With Non Metastatic Castration Resistant Prostate Cancer (NM-CRPC)

CompletedNCT04108208

Janssen Research & Development, LLCProstatic Neoplasms

Start: 2019-12-17End: 2026-06-05Updated: 2026-07-30

Unknown Phase

A Registry Study to Observe Clinical Outcomes of Participants With High-risk Metastatic Hormone-naïve Prostate Cancer in Japan

CompletedNCT04034095

Janssen Pharmaceutical K.K.Prostatic Neoplasms

Start: 2019-07-08End: 2024-08-13Updated: 2025-12-15

Related Papers

Validation of prostate-specific antigen (PSA) decline among the Latin American subgroup of LIBERTAS: A phase 3 study of apalutamide (APA) plus continuous versus intermittent androgen deprivation therapy (ADT) in metastatic castration-sensitive prostate cancer (mCSPC).

Journal of Clinical Oncology2026-05-27

Cognition of apalutamide + ADT treatment responders versus non-responders.

Journal of Clinical Oncology2026-05-27

Improving actigraphy adherence among clinical trial participants with a real-time data-driven workflow

BMC Digital Health2025-12-07

Deep prostate-specific antigen (PSA) decline among early participants (pts) in LIBERTAS, a phase 3 study of apalutamide (APA) plus continuous versus intermittent androgen deprivation therapy (ADT) in metastatic castration-sensitive prostate cancer (mCSPC).

Journal of Clinical Oncology2025-02-101 citations

LIBERTAS: A degendered and transgender-inclusive phase 3 study of apalutamide (APA) plus intermittent vs continuous androgen deprivation therapy (ADT) in participants (pts) with metastatic hormone-sensitive prostate cancer (mHSPC).

Journal of Clinical Oncology2024-06-01

Apalutamide (APA) plus intermittent versus continuous androgen-deprivation therapy (ADT) in participants (pts) with metastatic castration-sensitive prostate cancer (mCSPC): LIBERTAS phase 3 study design.

Journal of Clinical Oncology2024-01-296 citations

Phase II study of biweekly docetaxel plus androgen-deprivation therapy (ADT) in patients with previously-untreated, metastatic, prostatic adenocarcinoma.

Journal of Clinical Oncology2020-05-20

A retrospective, feasibility study of biweekly docetaxel in patients with high-risk, metastatic, hormone-sensitive, or castration-naive prostate cancer (mHSPC or mCNPC).

Journal of Clinical Oncology2018-05-20