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Clinical Trials List

Protocol Number64091742PCR3001
NCT Number(ClinicalTrials.gov Identfier)NCT03748641
Active

2019-01-01 - 2027-05-27

Phase III

Recruiting8

Terminated1

ICD-10C61

Malignant neoplasm of prostate

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9185

Malignant neoplasm of prostate

A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Subjects with Metastatic Prostate Cancer

  • Trial Applicant

    Johnson & Johnson

  • Sponsor

    Janssen Research & Development, LLC

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator 歐宴泉 Division of Hematology & Oncology
Kuang Tien General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 黃冠華 Division of Urology
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chao-Hsiang Chang Division of Urology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Hsiao-Jen Chung Division of Urology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator See-Tong Pang Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Shian-Shiang Wang Division of Urology
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yu-Chieh Tsai Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wen-Jeng Wu Division of Urology
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

6 Terminated

Principal Investigator 歐宴泉 Division of Hematology & Oncology
童綜合醫療社團法人童綜合醫院

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Metastatic prostate cancer

Objectives

The objective of this study is to compare niraparib and abiraterone acetate plus prednisone (AA-P) versus placebo plus AA-P plus for the treatment of subjects with various stages of metastatic prostate cancer.

Test Drug

Niraparib

Active Ingredient

Niraparib

Dosage Form

capsule

Dosage

100 mg

Endpoints

Primary
- Radiographic progression free survival(rPFS)
Secondary
- OS
- Time to chronic opioid use
- Time to pain progression
- Time to initiation of cytotoxic chemotherapy
Other
- Time to PSA progression based on PCWG3 criteria
- PFS on first subsequent therapy (PFS2)
- Time to symptomatic progression

Inclution Criteria

- DRD status (as identified by the sponsor’s required assays) as follows:
a) Cohort 1: positive for DRD
b) Cohort 2: not positive for DRD (ie, no DRD)
- Metastatic disease documented by positive bone scan or metastatic lesions on computed tomography (CT) or magnetic resonance imaging (MRI).
- Progression of metastatic prostate cancer in the setting of castrate levels of testosterone ≤50 ng/dL on a GnRHa, or history of bilateral orchiectomy at study entry as evidenced by PSA progression or radiographic progression.
- Able to continue GnRHa during the study if not surgically castrate.
- Score of ≤3 on the Brief Pain Inventory-Short Form (BPI-SF) Question #3 (worst pain in last 24 hours).

Exclusion Criteria

- Prior treatment with a PARP inhibitor.
- Systemic therapy (eg, enzalutamide, docetaxel) in the mCRPC setting with the exception of:
a) Less than 4 months of AA-P prior to randomization.
- Symptomatic brain metastases.
- History or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML).
- Other prior malignancy (exceptions: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) ≤2 years prior to randomization, or malignancy that currently requires active systemic therapy.

The Estimated Number of Participants

  • Taiwan

    36 participants

  • Global

    1100 participants

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