Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02854436




Registration number
NCT02854436
Ethics application status
Date submitted
1/08/2016
Date registered
3/08/2016
Date last updated
5/09/2024

Titles & IDs
Public title
An Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies
Scientific title
A Phase 2 Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies
Secondary ID [1] 0 0
64091742PCR2001
Secondary ID [2] 0 0
CR108208
Universal Trial Number (UTN)
Trial acronym
Galahad
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostatic Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Niraparib

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


Treatment: Drugs: Niraparib
Participants will receive 300 mg niraparib (3 capsules\*100 mg) orally once daily.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate (ORR) for Participants With Measurable Metastatic Castration-resistant Prostate Cancer (mCRPC) and Breast Cancer Gene (BRCA) Mutation
Timepoint [1] 0 0
Up to 52 months
Secondary outcome [1] 0 0
Objective Response Rate for Participants With Measurable Metastatic Castration-resistant Prostate Cancer (mCRPC) and Non-Breast Cancer Gene (BRCA) Mutation
Timepoint [1] 0 0
Up to 52 months
Secondary outcome [2] 0 0
Circulating Tumor Cells (CTC) Response Rate
Timepoint [2] 0 0
At 8 weeks post-baseline
Secondary outcome [3] 0 0
Overall Survival (OS)
Timepoint [3] 0 0
Up to 52 months
Secondary outcome [4] 0 0
Radiographic Progression-Free Survival (rPFS)
Timepoint [4] 0 0
Up to 52 months
Secondary outcome [5] 0 0
Time to Radiographic Progression
Timepoint [5] 0 0
Up to 52 months
Secondary outcome [6] 0 0
Time to Prostate-Specific Antigen (PSA) Progression
Timepoint [6] 0 0
Up to 52 months
Secondary outcome [7] 0 0
Time to Symptomatic Skeletal Event (SSE)
Timepoint [7] 0 0
Up to 52 months
Secondary outcome [8] 0 0
Duration of Objective Response
Timepoint [8] 0 0
Up to 52 months
Secondary outcome [9] 0 0
Number of Participants With Adverse Events (AEs)
Timepoint [9] 0 0
Up to 52 months
Secondary outcome [10] 0 0
Number of Participants With Worst Toxicity Grades for Clinical Laboratory Tests Based on National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Timepoint [10] 0 0
Up to 52 months

Eligibility
Key inclusion criteria
* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/08/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/08/2023
Sample size
Target
Accrual to date
Final
289
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Camperdown
Recruitment hospital [2] 0 0
- Darlinghurst
Recruitment hospital [3] 0 0
- East Albury
Recruitment hospital [4] 0 0
- Kurralta Park
Recruitment hospital [5] 0 0
- Macquarie University
Recruitment hospital [6] 0 0
- Melbourne
Recruitment hospital [7] 0 0
- Murdoch
Recruitment hospital [8] 0 0
- Port Macquarie
Recruitment hospital [9] 0 0
- Randwick
Recruitment hospital [10] 0 0
- Wahroonga
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment postcode(s) [2] 0 0
- Darlinghurst
Recruitment postcode(s) [3] 0 0
- East Albury
Recruitment postcode(s) [4] 0 0
- Kurralta Park
Recruitment postcode(s) [5] 0 0
- Macquarie University
Recruitment postcode(s) [6] 0 0
- Melbourne
Recruitment postcode(s) [7] 0 0
- Murdoch
Recruitment postcode(s) [8] 0 0
- Port Macquarie
Recruitment postcode(s) [9] 0 0
- Randwick
Recruitment postcode(s) [10] 0 0
- Wahroonga
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Nebraska
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
South Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Virginia
Country [16] 0 0
United States of America
State/province [16] 0 0
Washington
Country [17] 0 0
United States of America
State/province [17] 0 0
Wisconsin
Country [18] 0 0
Belgium
State/province [18] 0 0
Aalst
Country [19] 0 0
Belgium
State/province [19] 0 0
Brussel
Country [20] 0 0
Belgium
State/province [20] 0 0
Charleroi
Country [21] 0 0
Belgium
State/province [21] 0 0
Gent
Country [22] 0 0
Belgium
State/province [22] 0 0
Haine-Saint-Paul, La Louviere
Country [23] 0 0
Belgium
State/province [23] 0 0
Hasselt
Country [24] 0 0
Belgium
State/province [24] 0 0
Kortrijk
Country [25] 0 0
Belgium
State/province [25] 0 0
Liège
Country [26] 0 0
Belgium
State/province [26] 0 0
Namur
Country [27] 0 0
Belgium
State/province [27] 0 0
Ottignies
Country [28] 0 0
Belgium
State/province [28] 0 0
Wilrijk
Country [29] 0 0
Brazil
State/province [29] 0 0
Barretos
Country [30] 0 0
Brazil
State/province [30] 0 0
Belo Horizonte
Country [31] 0 0
Brazil
State/province [31] 0 0
Curitiba
Country [32] 0 0
Brazil
State/province [32] 0 0
Fortaleza
Country [33] 0 0
Brazil
State/province [33] 0 0
Ijui
Country [34] 0 0
Brazil
State/province [34] 0 0
Itajai
Country [35] 0 0
Brazil
State/province [35] 0 0
Joinville
Country [36] 0 0
Brazil
State/province [36] 0 0
Natal
Country [37] 0 0
Brazil
State/province [37] 0 0
Salvador
Country [38] 0 0
Brazil
State/province [38] 0 0
Sao Paulo
Country [39] 0 0
Canada
State/province [39] 0 0
British Columbia
Country [40] 0 0
Canada
State/province [40] 0 0
Ontario
Country [41] 0 0
Canada
State/province [41] 0 0
Quebec
Country [42] 0 0
Denmark
State/province [42] 0 0
Aarhus N.
Country [43] 0 0
Denmark
State/province [43] 0 0
Copenhagen N
Country [44] 0 0
Denmark
State/province [44] 0 0
Herlev
Country [45] 0 0
Denmark
State/province [45] 0 0
Odense C
Country [46] 0 0
France
State/province [46] 0 0
Avignon Cedex 9
Country [47] 0 0
France
State/province [47] 0 0
Besancon
Country [48] 0 0
France
State/province [48] 0 0
Caen
Country [49] 0 0
France
State/province [49] 0 0
Lyon
Country [50] 0 0
France
State/province [50] 0 0
Nice Cedex 2
Country [51] 0 0
France
State/province [51] 0 0
Paris
Country [52] 0 0
France
State/province [52] 0 0
Reims
Country [53] 0 0
France
State/province [53] 0 0
Strasbourg
Country [54] 0 0
France
State/province [54] 0 0
Villejuif Cedex
Country [55] 0 0
Israel
State/province [55] 0 0
Beer-Sheva
Country [56] 0 0
Israel
State/province [56] 0 0
Haifa
Country [57] 0 0
Israel
State/province [57] 0 0
Kfar Saba
Country [58] 0 0
Israel
State/province [58] 0 0
Ramat Gan
Country [59] 0 0
Israel
State/province [59] 0 0
Zrifin
Country [60] 0 0
Korea, Republic of
State/province [60] 0 0
Seoul
Country [61] 0 0
Netherlands
State/province [61] 0 0
Alkmaar
Country [62] 0 0
Netherlands
State/province [62] 0 0
Amsterdam
Country [63] 0 0
Netherlands
State/province [63] 0 0
Groningen
Country [64] 0 0
Netherlands
State/province [64] 0 0
Maastricht
Country [65] 0 0
Netherlands
State/province [65] 0 0
Rotterdam
Country [66] 0 0
Russian Federation
State/province [66] 0 0
Moscow
Country [67] 0 0
Russian Federation
State/province [67] 0 0
Omsk
Country [68] 0 0
Russian Federation
State/province [68] 0 0
Tomsk
Country [69] 0 0
Spain
State/province [69] 0 0
Barcelona
Country [70] 0 0
Spain
State/province [70] 0 0
Córdoba
Country [71] 0 0
Spain
State/province [71] 0 0
Madrid
Country [72] 0 0
Spain
State/province [72] 0 0
Málaga
Country [73] 0 0
Spain
State/province [73] 0 0
Pozuelo de Alarcon
Country [74] 0 0
Spain
State/province [74] 0 0
Santander
Country [75] 0 0
Spain
State/province [75] 0 0
Santiago de Compostela
Country [76] 0 0
Spain
State/province [76] 0 0
Sevilla
Country [77] 0 0
Spain
State/province [77] 0 0
Valencia
Country [78] 0 0
Sweden
State/province [78] 0 0
Göteborg
Country [79] 0 0
Sweden
State/province [79] 0 0
Lund
Country [80] 0 0
Sweden
State/province [80] 0 0
Stockholm
Country [81] 0 0
Sweden
State/province [81] 0 0
Umeå
Country [82] 0 0
Taiwan
State/province [82] 0 0
Kaohsiung
Country [83] 0 0
Taiwan
State/province [83] 0 0
Taichung
Country [84] 0 0
Taiwan
State/province [84] 0 0
Tainan
Country [85] 0 0
Taiwan
State/province [85] 0 0
Taipei
Country [86] 0 0
Taiwan
State/province [86] 0 0
Taoyuan County
Country [87] 0 0
United Kingdom
State/province [87] 0 0
Blackburn
Country [88] 0 0
United Kingdom
State/province [88] 0 0
Bristol
Country [89] 0 0
United Kingdom
State/province [89] 0 0
Cardiff
Country [90] 0 0
United Kingdom
State/province [90] 0 0
Exeter
Country [91] 0 0
United Kingdom
State/province [91] 0 0
London
Country [92] 0 0
United Kingdom
State/province [92] 0 0
Preston

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT02854436
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02854436