An Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies

NCT02854436 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: CR10820864091742PCR20012016-002057-38
• Study Type: interventional
• Target: 289
• Locations: 15 countries
• Sites: 110

Brief Summary

The purpose of this study is to assess the efficacy, safety, and pharmacokinetics of niraparib in men with metastatic castration-resistant prostate cancer (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies.

Conditions

Prostatic Neoplasms

Keywords

Prostate cancer; CRPC; Metastatic castrate-resistant prostate cancer; Prostate neoplasm; Galahad; Niraparib; DNA anomalies; DNA defect; PARP inhibitor; PARPi

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) for Participants With Measurable Metastatic Castration-resistant Prostate Cancer (mCRPC) and Breast Cancer Gene (BRCA) Mutation

  ORR defined as percentage of participants with BRCA DNA-repair anomalies and measurable disease whose best response is either complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and with no evidence of bone progression per Prostate Cancer Working Group 3 (PCWG3) criteria.

  Up to 52 months

Secondary Outcomes (10)

• Objective Response Rate for Participants With Measurable Metastatic Castration-resistant Prostate Cancer (mCRPC) and Non-Breast Cancer Gene (BRCA) Mutation

  Up to 52 months

• Circulating Tumor Cells (CTC) Response Rate

  At 8 weeks post-baseline

• Overall Survival (OS)

  Up to 52 months

• Radiographic Progression-Free Survival (rPFS)

  Up to 52 months

• Time to Radiographic Progression

  Up to 52 months

Study Arms (1)

Niraparib

EXPERIMENTAL

Participants will receive 300 milligram (mg) niraparib (3 capsules\*100 mg) orally once daily.

Drug: Niraparib

Interventions

Niraparib DRUG

Participants will receive 300 mg niraparib (3 capsules\*100 mg) orally once daily.

Also known as: JNJ-64091742

Niraparib

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed prostate cancer (mixed histology is acceptable, with the exception of the small cell pure phenotype, which is excluded)
• Received a taxane-based chemotherapy for the treatment of metastatic prostate cancer with evidence of disease progression on or after treatment, or discontinued from a taxane-based chemotherapy due to an adverse event
• Received a second-generation or later androgen receptor (AR)-targeted therapy (for example, abiraterone acetate plus prednisone, enzalutamide, apalutamide) for the treatment of metastatic prostate cancer with evidence of disease progression or non-metastatic castration-resistant prostate cancer with evidence of subsequent metastasis
• Biomarker-positive by at least one of the following criteria: (a) Biallelic deoxyribonucleic acid (DNA)-repair anomaly based on a sponsor validated blood or tissue assay; (b) Germline pathogenic Breast Cancer gene (BRCA) 1 or BRCA2 by any test (somatic local results must be confirmed as positive by the sponsor-validated assay before dosing)
• Progression of metastatic prostate cancer in the setting of castrate levels of testosterone or history of bilateral orchiectomy at study entry

You may not qualify if:

• Prior treatment with a poly (adenosine diphosphate \[ADP\] ribose) polymerase (PARP) inhibitor
• Prior platinum-based chemotherapy for the treatment of prostate cancer
• Known history or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)
• Symptomatic or impending cord compression
• Symptomatic brain metastases

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (110)

Unknown Facility

Tucson, Arizona, United States

Location

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

Riverside, California, United States

Location

Unknown Facility

Sacramento, California, United States

Location

Unknown Facility

Aurora, Colorado, United States

Location

Unknown Facility

Denver, Colorado, United States

Location

Unknown Facility

Evanston, Illinois, United States

Location

Unknown Facility

Danville, Kentucky, United States

Location

Unknown Facility

Louisville, Kentucky, United States

Location

Unknown Facility

New Orleans, Louisiana, United States

Location

Unknown Facility

Boston, Massachusetts, United States

Location

Unknown Facility

Detroit, Michigan, United States

Location

Unknown Facility

Omaha, Nebraska, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Durham, North Carolina, United States

Location

Unknown Facility

Lancaster, Pennsylvania, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Unknown Facility

Myrtle Beach, South Carolina, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

Charlottesville, Virginia, United States

Location

Unknown Facility

Fairfax, Virginia, United States

Location

Unknown Facility

Seattle, Washington, United States

Location

Unknown Facility

Madison, Wisconsin, United States

Location

Unknown Facility

Camperdown, Australia

Location

Unknown Facility

Darlinghurst, Australia

Location

Unknown Facility

East Albury, Australia

Location

Unknown Facility

Kurralta Park, Australia

Location

Unknown Facility

Macquarie University, Australia

Location

Unknown Facility

Melbourne, Australia

Location

Unknown Facility

Murdoch, Australia

Location

Unknown Facility

Port Macquarie, Australia

Location

Unknown Facility

Randwick, Australia

Location

Unknown Facility

Wahroonga, Australia

Location

Unknown Facility

Aalst, Belgium

Location

Unknown Facility

Brussels, Belgium

Location

Unknown Facility

Charleroi, Belgium

Location

Unknown Facility

Ghent, Belgium

Location

Unknown Facility

Haine-Saint-Paul, Belgium

Location

Unknown Facility

Hasselt, Belgium

Location

Unknown Facility

Kortrijk, Belgium

Location

Unknown Facility

Liège, Belgium

Location

Unknown Facility

Namur, Belgium

Location

Unknown Facility

Ottignies, Belgium

Location

Unknown Facility

Wilrijk, Belgium

Location

Unknown Facility

Barretos, Brazil

Location

Unknown Facility

Belo Horizonte, Brazil

Location

Unknown Facility

Curitiba, Brazil

Location

Unknown Facility

Fortaleza, Brazil

Location

Unknown Facility

Ijuí, Brazil

Location

Unknown Facility

Itajaí, Brazil

Location

Unknown Facility

Joinville, Brazil

Location

Unknown Facility

Natal, Brazil

Location

Unknown Facility

Salvador, Brazil

Location

Unknown Facility

São Paulo, Brazil

Location

Unknown Facility

Vancouver, British Columbia, Canada

Location

Unknown Facility

Oshawa, Ontario, Canada

Location

Unknown Facility

Toronto, Ontario, Canada

Location

Unknown Facility

Montreal, Quebec, Canada

Location

Unknown Facility

Québec, Quebec, Canada

Location

Unknown Facility

Aarhus N, Denmark

Location

Unknown Facility

Copenhagen N, Denmark

Location

Unknown Facility

Herlev, Denmark

Location

Unknown Facility

Odense C, Denmark

Location

Unknown Facility

Avignon, France

Location

Unknown Facility

Besançon, France

Location

Unknown Facility

Caen, France

Location

Unknown Facility

Lyon, France

Location

Unknown Facility

Nice, France

Location

Unknown Facility

Paris, France

Location

Unknown Facility

Reims, France

Location

Unknown Facility

Strasbourg, France

Location

Unknown Facility

Villejuif, France

Location

Unknown Facility

Beersheba, Israel

Location

Unknown Facility

Haifa, Israel

Location

Unknown Facility

Kfar Saba, Israel

Location

Unknown Facility

Ramat Gan, Israel

Location

Unknown Facility

Zrifin, Israel

Location

Unknown Facility

Alkmaar, Netherlands

Location

Unknown Facility

Amsterdam, Netherlands

Location

Unknown Facility

Groningen, Netherlands

Location

Unknown Facility

Maastricht, Netherlands

Location

Unknown Facility

Rotterdam, Netherlands

Location

Unknown Facility

Moscow, Russia

Location

Unknown Facility

Omsk, Russia

Location

Unknown Facility

Tomsk, Russia

Location

Unknown Facility

Seoul, South Korea

Location

Unknown Facility

Barcelona, Spain

Location

Unknown Facility

Córdoba, Spain

Location

Unknown Facility

Madrid, Spain

Location

Unknown Facility

Málaga, Spain

Location

Unknown Facility

Pozuelo de Alarcón, Spain

Location

Unknown Facility

Santander, Spain

Location

Unknown Facility

Santiago de Compostela, Spain

Location

Unknown Facility

Seville, Spain

Location

Unknown Facility

Valencia, Spain

Location

Unknown Facility

Gothenburg, Sweden

Location

Unknown Facility

Lund, Sweden

Location

Unknown Facility

Stockholm, Sweden

Location

Unknown Facility

Umeå, Sweden

Location

Unknown Facility

Kaohsiung City, Taiwan

Location

Unknown Facility

Taichung, Taiwan

Location

Unknown Facility

Tainan, Taiwan

Location

Unknown Facility

Taipei, Taiwan

Location

Unknown Facility

Taoyuan, Taiwan

Location

Unknown Facility

Blackburn, United Kingdom

Location

Unknown Facility

Bristol, United Kingdom

Location

Unknown Facility

Cardiff, United Kingdom

Location

Unknown Facility

Exeter, United Kingdom

Location

Unknown Facility

London, United Kingdom

Location

Unknown Facility

Preston, United Kingdom

Location

Related Publications (2)

• Smith MR, Sandhu S, George DJ, Chi KN, Saad F, Thiery-Vuillemin A, Stahl O, Olmos D, Danila DC, Gafanov R, Castro E, Moon H, Joshua AM, Mason GE, Espina BM, Liu Y, Lopez-Gitlitz A, Francis P, Bevans KB, Fizazi K. Health-related quality of life in GALAHAD: A multicenter, open-label, phase 2 study of niraparib for patients with metastatic castration-resistant prostate cancer and DNA-repair gene defects. J Manag Care Spec Pharm. 2023 Jul;29(7):758-768. doi: 10.18553/jmcp.2023.29.7.758.

  PMID: 37404070 DERIVED

• Smith MR, Scher HI, Sandhu S, Efstathiou E, Lara PN Jr, Yu EY, George DJ, Chi KN, Saad F, Stahl O, Olmos D, Danila DC, Mason GE, Espina BM, Zhao X, Urtishak KA, Francis P, Lopez-Gitlitz A, Fizazi K; GALAHAD investigators. Niraparib in patients with metastatic castration-resistant prostate cancer and DNA repair gene defects (GALAHAD): a multicentre, open-label, phase 2 trial. Lancet Oncol. 2022 Mar;23(3):362-373. doi: 10.1016/S1470-2045(21)00757-9. Epub 2022 Feb 4.

  PMID: 35131040 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

niraparib

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: EXECUTIVE MEDICAL DIRECTOR
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2016
• First Posted: August 3, 2016
• Study Start: August 31, 2016
• Primary Completion: January 26, 2021
• Study Completion: August 16, 2023
• Last Updated: December 22, 2025
• Results First Posted: March 8, 2022

Record last verified: 2025-12

Locations

AU (10); NL (5); TW (5); DK (4); KR (1); BR (10); SE (4); ES (9); IL (5); US (23); GB (6); BE (11); RU (3); FR (9); CA (5)