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Clinical Trials List

Protocol Number67652000PCR3002
NCT Number(ClinicalTrials.gov Identfier)NCT04497844
Active

2020-10-26 - 2028-06-30

Phase III

Not yet recruiting1

Recruiting1

Terminated7

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 the Treatment of Participants with Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

  • Trial Applicant

    Johnson & Johnson

  • Sponsor

    Janssen Research & Development, LLC

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Hsi-Chin Wu Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator - - Division of Urology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Yi-Hsiu Huang Division of Urology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Kai-Jie Yu Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Yu-Li Su Division of Hematology & Oncology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

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

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

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

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop 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

0 Stop recruiting

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 Castration-Sensitive Prostate Cancer

Objectives

• To determine if niraparib and AA, plus prednisone compared with AA plus prednisone in participants with deleterious germline or somatic HRR gene-mutated mCSPC provides superior efficacy in improving radiographic progression-free survival (rPFS). • To assess the clinical benefit of niraparib and AA, plus prednisone compared with AA plus prednisone in participants with deleterious germline or somatic HRR gene-mutated mCSPC. • To characterize the safety profile of niraparib and AA, plus prednisone compared with AA plus prednisone in participants with deleterious germline or somatic HRR gene-mutated mCSPC.

Test Drug

Niraparib

Active Ingredient

Niraparib

Dosage Form

Capsule

Dosage

100 mg

Endpoints

The primary endpoint for this study is rPFS as assessed by the investigator which will be evaluated using computed tomography or magnetic resonance imaging scans and whole-body bone scans (Technetium-99m). Evaluation of rPFS will also be assessed by blinded independent central review.

Inclution Criteria

- >18 years of age (or the local legal age of consent).
- Diagnosis of prostate adenocarcinoma.
- Willing to provide an archival tumor tissue sample or a fresh tumor tissue sample. If germline positive for deleterious germline or somatic HRR gene mutations, an archived or fresh tumor tissue sample is not required.
- Metastatic disease documented by ≥1 bone lesion(s) on 99mTc bone scan. Participants with a single bone lesion must have confirmation of bone metastasis by CT or MRI.
- Androgen deprivation therapy (either medical or surgical castration) must have been started >14 days prior to randomization and willing to continue through the treatment phase. Participants who start a GnRH agonist <28 days prior to randomization will be required to take a first-generation anti-androgen for >14 days prior to randomization. The anti-androgen must be discontinued prior to randomization.
- Other allowed prior therapy for mCSPC:
a. Maximum of 1 course of radiation or surgical intervention to manage symptoms of
prostate cancer. Radiation with curative intent is not allowed. Radiation must be
completed prior to randomization.
b. <6 months of ADT prior to randomization.
c. 30 days of AA-P allowed if required.

Exclusion Criteria

- Pathological finding consistent with small cell ductal or neuroendocrine carcinoma of the prostate.
- Prior treatment with a PARP inhibitor.
- History of adrenal dysfunction.
- Long-term use of systemically administered corticosteroids (>5 mg of prednisone or the equivalent) during the study is not allowed. Short-term use (≤4 weeks, including taper) and locally administered steroids (eg, inhaled, topical, ophthalmic, and intra-articular) are allowed, if clinically indicated.
- History or current diagnosis of MDS/AML.

The Estimated Number of Participants

  • Taiwan

    20 participants

  • Global

    692 participants

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