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NCT Number: NCT03748641

A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer

The purpose of this study is to evaluate the effectiveness of niraparib in combination with abiraterone acetate plus prednisone (AAP) compared to AAP and placebo.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Castration-Resistant Prostatic Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Prostatic Neoplasms, Castration-Resistant Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

CEMIC Saavedra, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HRR gene alteration (as identified by the sponsor's required assays) as follows:
  • Cohort 1: positive for HRR gene alteration
  • Cohort 2: not positive for DRD (that is, HRR gene alteration)
  • Cohort 3: eligible by HRR status
  • Metastatic disease documented by positive bone scan or metastatic lesions on computed tomography (CT) or magnetic resonance imaging (MRI)
  • Metastatic prostate cancer in the setting of castrate levels of testosterone less than or equal to (<=) 50 nanogram per deciliter (ng/dL) on a gonadotropin releasing hormone analog (GnRHa) or bilateral orchiectomy
  • Able to continue GnRHa during the study if not surgically castrate
  • Score of <= 3 on the brief pain inventory-short form (BPI-SF) question number 3 (worst pain in last 24 hours)

Exclusion criteria

  • Prior treatment with a poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor
  • Systemic therapy (that is, novel second-generation AR-targeted therapy such as enzalutamide, apalutamide, or darolutamide; taxane-based chemotherapy, or more than 4 months of abiraterone acetate plus prednisone [AAP] prior to randomization) in the metastatic castration-resistant prostate cancer (mCRPC) setting; or AAP outside of the mCRPC setting
  • 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

Treatment and study plan

Niraparib

Drug

Participants will receive niraparib 200 mg capsules or tablets once daily.

Other names: JNJ-64091742

Abiraterone Acetate

Drug

Participants will receive AA 1000 mg tablets once daily.

Prednisone

Drug

Participants will receive prednisone 10 mg tablets daily.

Placebo

Drug

Participants will receive matching placebo once daily.

New Formulation of Niraparib and Abiraterone Acetate (AA)

Drug

Participants will receive a new formulation of niraparib 200 mg and AA 1000 mg tablets once daily.

Primary outcomes

  1. Cohort 1: Radiographic Progression-Free Survival (rPFS) as Assessed by Blinded Independent Central Review (BICR)

    Time frame: Up to 32 months

    As per BICR, rPFS is time interval from the date of randomization to radiographic progression or death, whichever occurred first. Radiographic progression was determined by: (1) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI) as per response evaluation criteria in solid tumors (RECIST) 1.1; (2) Progression of bone lesions observed by bone scan based on prostate cancer working group 3 (PCWG3) criteria. PCWG3 criteria: bone progression was confirmed by subsequent scan greater than or equal to (>=) 6 weeks later. Week 8 scan was baseline to which all subsequent scans were compared to determine progression. Confirmatory scan >=2 new lesions indicate progression; scan does not show >=2 new lesions means no progression. If Week 8 scan less than (<) 2 new bone lesions compared to baseline, the initial scan >=2 new lesions compared to Week 8 scan indicates progression if confirmed by subsequent scan >=6 weeks later.

  2. Cohort 1 Breast Cancer Gene (BRCA) Subgroup: Radiographic Progression-Free Survival (rPFS) as Assessed by Blinded Independent Central Review (BICR)

    Time frame: Up to 32 months

    As per BICR, rPFS is time interval from the date of randomization to radiographic progression or death, whichever occurred first. Radiographic progression was determined by: (1) progression of soft tissue lesions measured by CT or MRI as per RECIST 1.1; (2) Progression of bone lesions observed by bone scan based on PCWG3 criteria. PCWG3 criteria: bone progression was confirmed by subsequent scan >=6 weeks later. Week 8 scan was baseline to which all subsequent scans were compared to determine progression. Confirmatory scan >=2 new lesions indicate progression; scan does not show >=2 new lesions means no progression. If Week 8 scan <2 new bone lesions compared to baseline, the initial scan >=2 new lesions compared to Week 8 scan indicates progression if confirmed by subsequent scan >=6 weeks later.

Secondary outcomes

  1. Cohort 1: Overall Survival (OS)

    Time frame: Up to 97 months

  2. Cohort 1: Time to Symptomatic Progression

    Time frame: Up to 97 months

  3. Cohort 1: Time to Initiation of Cytotoxic Chemotherapy

    Time frame: Up to 97 months

  4. Observed Plasma Concentrations of Niraparib

    Time frame: Up to 97 months

  5. Observed Plasma Concentrations of Abiraterone

    Time frame: Up to 97 months

  6. Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Up to 96 months

  7. Number of Participants With Treatment-Emergent Adverse Events by Severity

    Time frame: Up to 96 months

  8. Number of Participants With Abnormalities in Laboratory Values

    Time frame: Up to 96 months

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

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

Acronym: MAGNITUDE

Important dates

Study start
2019
Primary completion
2021
Study completion
2027
First posted
Nov 21, 2018
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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