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Prostatic NeoplasmsPhase 2GalahadNCT02854436

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

A Phase 2 study testing Niraparib in people with Prostatic Neoplasms, run by Janssen Research & Development, LLC at 110 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostatic Neoplasms
What is being tested?
Niraparib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
289 participants
Where
110 sitesin 15 countries
Study dates
31 Aug 2016to 16 Aug 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

110 sites in 15 countries.

110 sites in 15 countries

United States23 sites

  • Study site

    Aurora, Colorado

  • Study site

    Boston, Massachusetts

  • Study site

    Charlottesville, Virginia

  • Study site

    Danville, Kentucky

  • Study site

    Denver, Colorado

  • Study site

    Detroit, Michigan

  • Study site

    Durham, North Carolina

  • Study site

    Evanston, Illinois

  • Study site

    Fairfax, Virginia

  • Study site

    Houston, Texas

  • Study site

    Lancaster, Pennsylvania

  • Study site

    Los Angeles, California

  • Study site

    Louisville, Kentucky

  • Study site

    Madison, Wisconsin

  • Study site

    Myrtle Beach, South Carolina

  • Study site

    New Orleans, Louisiana

  • Study site

    New York, New York

  • Study site

    Omaha, Nebraska

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Riverside, California

  • Study site

    Sacramento, California

  • Study site

    Seattle, Washington

  • Study site

    Tucson, Arizona

Other trials in United States

Belgium11 sites

  • Study site

    Aalst

  • Study site

    Brussels

  • Study site

    Charleroi

  • Study site

    Ghent

  • Study site

    Haine-Saint-Paul

  • Study site

    Hasselt

  • Study site

    Kortrijk

  • Study site

    Liège

  • Study site

    Namur

  • Study site

    Ottignies

  • Study site

    Wilrijk

Other trials in Belgium

Australia10 sites

  • Study site

    Camperdown

  • Study site

    Darlinghurst

  • Study site

    East Albury

  • Study site

    Kurralta Park

  • Study site

    Macquarie University

  • Study site

    Melbourne

  • Study site

    Murdoch

  • Study site

    Port Macquarie

  • Study site

    Randwick

  • Study site

    Wahroonga

Other trials in Australia

Brazil10 sites

  • Study site

    Barretos

  • Study site

    Belo Horizonte

  • Study site

    Curitiba

  • Study site

    Fortaleza

  • Study site

    Ijuí

  • Study site

    Itajaí

  • Study site

    Joinville

  • Study site

    Natal

  • Study site

    Salvador

  • Study site

    São Paulo

Other trials in Brazil

France9 sites

  • Study site

    Avignon

  • Study site

    Besançon

  • Study site

    Caen

  • Study site

    Lyon

  • Study site

    Nice

  • Study site

    Paris

  • Study site

    Reims

  • Study site

    Strasbourg

  • Study site

    Villejuif

Other trials in France

Spain9 sites

  • Study site

    Barcelona

  • Study site

    Córdoba

  • Study site

    Madrid

  • Study site

    Málaga

  • Study site

    Pozuelo de Alarcón

  • Study site

    Santander

  • Study site

    Santiago de Compostela

  • Study site

    Seville

  • Study site

    Valencia

Other trials in Spain

United Kingdom6 sites

  • Study site

    Blackburn

  • Study site

    Bristol

  • Study site

    Cardiff

  • Study site

    Exeter

  • Study site

    London

  • Study site

    Preston

Other trials in United Kingdom

Canada5 sites

  • Study site

    Montreal, Quebec

  • Study site

    Oshawa, Ontario

  • Study site

    Québec, Quebec

  • Study site

    Toronto, Ontario

  • Study site

    Vancouver, British Columbia

Other trials in Canada

Israel5 sites

  • Study site

    Beersheba

  • Study site

    Haifa

  • Study site

    Kfar Saba

  • Study site

    Ramat Gan

  • Study site

    Zrifin

Other trials in Israel

Netherlands5 sites

  • Study site

    Alkmaar

  • Study site

    Amsterdam

  • Study site

    Groningen

  • Study site

    Maastricht

  • Study site

    Rotterdam

Other trials in Netherlands

Taiwan5 sites

  • Study site

    Kaohsiung City

  • Study site

    Taichung

  • Study site

    Tainan

  • Study site

    Taipei

  • Study site

    Taoyuan County

Other trials in Taiwan

Denmark4 sites

  • Study site

    Aarhus N

  • Study site

    Copenhagen N

  • Study site

    Herlev

  • Study site

    Odense C

Other trials in Denmark

Sweden4 sites

  • Study site

    Gothenburg

  • Study site

    Lund

  • Study site

    Stockholm

  • Study site

    Umeå

Other trials in Sweden

Russia3 sites

  • Study site

    Moscow

  • Study site

    Omsk

  • Study site

    Tomsk

Other trials in Russia

South Korea1 site

  • Study site

    Seoul

Other trials in South Korea

About this study

Official title: A Phase 2 Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies

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.

Read the detailed description

This is a multicenter and open-label (participants and researchers are aware of the treatment that participants are receiving) study that consists of 4 phases: a Prescreening Phase for biomarker evaluation only, a Screening Phase, a Treatment Phase (Cycle 1 Day 1 and will continue until the study drug is discontinued), a Follow-up Phase (every 3 months after end of treatment visit), and a Long-term Extension Phase (until participants no longer derive benefit from treatment or until further notification on different means of study treatment). Participants will be monitored for safety during the study period, and up to 30 days after the last dose of study drug.

Being tested
Niraparib
Keywords
Prostate cancer, CRPC, Metastatic castrate-resistant prostate cancer, Prostate neoplasm, Galahad, Niraparib, DNA anomalies, DNA defect, PARP inhibitor, PARPi
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NiraparibDrug

    Also called JNJ-64091742

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

Study groups in NCT02854436
Study groupRoleWhat they receive
NiraparibExperimentalParticipants will receive 300 milligram (mg) niraparib (3 capsules*100 mg) orally once daily.
Receives: Drug: Niraparib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 52 months

Secondary outcomes (10)

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

    ORR defined as percentage of participants with BRCA deoxyribonucleic acid (DNA)-repair anomalies and measurable disease whose best response is either CR or PR per RECIST 1.1 and with no evidence of bone progression per PCWG3 criteria.

    Measured: Up to 52 months

  2. Circulating Tumor Cells (CTC) Response Rate

    CTC response rate was defined as the percentage of participants with CTC equals to (=) 0 per 7.5 milliliter (mL) blood at 8 weeks post-baseline in participants with baseline CTC greater than (>) 0.

    Measured: At 8 weeks post-baseline

  3. Overall Survival (OS)

    OS is defined as time from enrollment to death from any cause.

    Measured: Up to 52 months

  4. Radiographic Progression-Free Survival (rPFS)

    rPFS was defined as time from enrollment to radiographic progression or death from any cause, whichever occurred first. Radiographic progression was evaluated per RECIST 1.1 criteria for soft tissue disease and per PCWG3 criteria for bone disease.

    Measured: Up to 52 months

  5. Time to Radiographic Progression

    Time to radiographic progression is defined as time from enrollment to radiographic progression or death due to disease progression, whichever occurs first. Disease progression is defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.

    Measured: Up to 52 months

  6. Time to Prostate-Specific Antigen (PSA) Progression

    Time to PSA progression was defined as time from enrollment to the first date of documented PSA progression based on PCWG3 criteria. A participant was considered to have a PSA progression if the PSA level had a 25 percent (%) or greater increase from nadir and an absolute increase of 2 nanograms per milliliter (ng/mL) or more, which is confirmed by a second value obtained in 3 or more weeks.

    Measured: Up to 52 months

  7. Time to Symptomatic Skeletal Event (SSE)

    Time to SSE was defined as the time from enrollment to first occurrence of one of the following symptomatic skeletal events: tumor-related spinal cord compression, radiation to bone to relieve skeletal symptoms, surgery to bone or need for tumor-related orthopedic surgical intervention, symptomatic or pathologic fracture.

    Measured: Up to 52 months

  8. Duration of Objective Response

    Duration of objective response is defined as time from CR or PR to radiographic progression of disease, unequivocal clinical progression or death, whichever occurs first. Unequivocal clinical progression defined as one or more of following: 1) deterioration in Eastern Cooperative Oncology Group Performance Status (ECOG PS) to Grade 3 or higher; 2) need to initiate any of following because of tumor progression (even in absence of radiographic evidence of disease): alternative anticancer therapy for prostate cancer, radiation therapy, surgical interventions for complications due to tumor progression.

    Measured: Up to 52 months

  9. Number of Participants With Adverse Events (AEs)

    An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study.

    Measured: Up to 52 months

  10. Number of Participants With Worst Toxicity Grades for Clinical Laboratory Tests Based on National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE)

    Number of participants with worst toxicity grades for clinical laboratory tests (chemistry and hematology) based on NCI-CTCAE were reported. The chemistry laboratory parameters were: alanine aminotransferase (ALT) increased, alkaline phosphatase increased, aspartate aminotransferase (AST) increased, blood bilirubin increased, creatinine increased, gamma glutamyl transferase (GGT) increased and the hematology parameters were: hemoglobin increased, lymphocyte count increased. Grading was done as: Grade 1 (=mild), Grade 2 (=moderate), Grade 3 (=severe) and Grade 4 (=potentially life-threatening).

    Measured: Up to 52 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2016 (estimated)
  2. Study start31 Aug 2016
  3. Primary completion26 Jan 2021
  4. Study completion16 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
289 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02854436
Sponsor's protocol ID
CR108208
Other IDs
64091742PCR2001, 2016-002057-38, 2016
Acronym
Galahad
Status last verified
Dec 2025
First submitted
1 Aug 2016
Last updated
22 Dec 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Russu A, Hazra A, Tian H, Haddish-Berhane N, Perez Ruixo JJ, Boulton M. Population Pharmacokinetics of Niraparib/Abiraterone Acetate Administered as Single-Agent Combination and Dual-Acting Tablets Plus Prednisone for Metastatic Castration-Resistant Prostate Cancer. Adv Ther. 2025 Apr;42(4):1860-1880. doi: 10.1007/s12325-025-03104-y. Epub 2025 Feb 28.

    PubMed 40016438

  • 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.

    PubMed 37404070

  • 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.

    PubMed 35131040

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Niraparib in people with Prostatic Neoplasms, run by Janssen Research & Development, LLC at 110 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 110 sites in United States, Belgium, Australia, Brazil, France and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) for Participants With Measurable Metastatic Castration-resistant Prostate Cancer (mCRPC) and Breast Cancer Gene (BRCA) Mutation (time frame: Up to 52 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02854436, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.

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