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

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ClinicalTrials.gov Identifier: NCT02854436

Recruitment Status : Completed

First Posted : August 3, 2016

Results First Posted : March 8, 2022

Last Update Posted : November 13, 2023

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Sponsor:

Information provided by (Responsible Party):

Janssen Research & Development, LLC

Study Type	Interventional
Study Design	Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Prostatic Neoplasms
Intervention	Drug: Niraparib
Enrollment	289

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Niraparib
Arm/Group Description	Male participants who were over the...
Arm/Group Description	Male participants who were over the age of 18 years with metastatic castration-resistant prostate cancer (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies and who had received prior taxane-based chemotherapy and androgen receptor (AR)-targeted therapy received once daily oral dose of 300 milligrams (mg) niraparib capsules starting Day 1 until disease progression, unacceptable toxicity, death, or termination of the study by the sponsor (up to 52 months).
Period Title: Overall Study
Started	289
Intent to Treat Participants (Breast Cancer Gene [BRCA] and Non-BRCA Participants)	223 ^[1]
Completed	0
Not Completed	289
Reason Not Completed
Adverse Event	1
Death	208
Lost to Follow-up	5
Withdrawal by Subject	12
Other	45
Ongoing	18
[1] There were 142 BRCA participants and 81 non-BRCA participants.

Baseline Characteristics

Arm/Group Title		Niraparib
Arm/Group Description		Male participants who were over the...
Arm/Group Description		Male participants who were over the age of 18 years with metastatic castration-resistant prostate cancer (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies and who had received prior taxane-based chemotherapy and androgen receptor (AR)-targeted therapy received once daily oral dose of 300 milligrams (mg) niraparib capsules starting Day 1 until disease progression, unacceptable toxicity, death, or termination of the study by the sponsor (up to 52 months).
Overall Number of Baseline Participants		289
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	289 participants
		68.8 (7.8)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	289 participants
	Female	0 0.0%
	Male	289 100.0%
Race/Ethnicity, Customized Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	289 participants
American Indian or Alaska Native		0 0.0%
Asian		16 5.5%
Black or African American		9 3.1%
Native Hawaiian or Other Pacific Islander		0 0.0%
White		205 70.9%
More than one race		3 1.0%
Unknown or Not Reported		51 17.6%
Other		5 1.7%
Region of Enrollment Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	289 participants
AUSTRALIA		31 10.7%
BELGIUM		18 6.2%
BRAZIL		12 4.2%
CANADA		21 7.3%
DENMARK		1 0.3%
FRANCE		48 16.6%
ISRAEL		6 2.1%
NETHERLANDS		6 2.1%
RUSSIAN FEDERATION		7 2.4%
SOUTH KOREA		5 1.7%
SPAIN		39 13.5%
SWEDEN		24 8.3%
TAIWAN		9 3.1%
UNITED KINGDOM		17 5.9%
UNITED STATES		45 15.6%

Outcome Measures

1.Primary Outcome


Title	Objective Response Rate (ORR) for Participants With Measurable Metastatic Castration-resistant Prostate Cancer (mCRPC) and Breast Cancer Gene (BRCA) Mutation
Description	ORR defined as percentage of participants with BRCA DNA-repair anomali...
Description	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.
Time Frame	Up to 52 months

Outcome Measure Data

Analysis Population Description

Measurable intent to treat (ITT) population also referred to as efficacy analysis set included all participants who received at least 1 dose of study drug and have BRCA (biallelic or germline DNA-repair anomalies) and measurable disease at baseline.


Arm/Group Title	Niraparib
Arm/Group Description:	Male participants who were over the...
Arm/Group Description:	Male participants who were over the age of 18 years with metastatic castration-resistant prostate cancer (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies and who had received prior taxane-based chemotherapy and androgen receptor (AR)-targeted therapy received once daily oral dose of 300 milligrams (mg) niraparib capsules starting Day 1 until disease progression, unacceptable toxicity, death, or termination of the study by the sponsor (up to 52 months).
Overall Number of Participants Analyzed	76
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: percentage of participants
	34.2 (23.7 to 46.0)

2.Secondary Outcome


Title	Objective Response Rate for Participants With Measurable Metastatic Castration-resistant Prostate Cancer (mCRPC) and Non-Breast Cancer Gene (BRCA) Mutation
Description	ORR defined as percentage of participants with BRCA deoxyribonucleic a...
Description	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.
Time Frame	Up to 52 months

Outcome Measure Data

Analysis Population Description

Measurable ITT analysis set included all participants who received at least 1 dose of study drug and have non-BRCA (biallelic DNA-repair anomaly) and measurable disease at baseline.


Arm/Group Title	Niraparib
Arm/Group Description:	Male participants who were over the...
Arm/Group Description:	Male participants who were over the age of 18 years with metastatic castration-resistant prostate cancer (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies and who had received prior taxane-based chemotherapy and androgen receptor (AR)-targeted therapy received once daily oral dose of 300 milligrams (mg) niraparib capsules starting Day 1 until disease progression, unacceptable toxicity, death, or termination of the study by the sponsor (up to 52 months).
Overall Number of Participants Analyzed	47
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: percentage of participants
	10.6 (3.5 to 23.1)

3.Secondary Outcome


Title	Circulating Tumor Cells (CTC) Response Rate
Description	CTC response rate was defined as the percentage of participants with C...
Description	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.
Time Frame	At 8 weeks post-baseline

Outcome Measure Data

Analysis Population Description

ITT analysis set included all participants who received at least 1 dose of study drug. Here 'N' (number of participants analysed) specifies the participants with baseline CTC (per 7.5 mL blood) > 0. Here, 'n' (number analyzed) specifies the number of participants evaluated for specific categories.


Arm/Group Title		Niraparib
Arm/Group Description:		Male participants who were over the...
Arm/Group Description:		Male participants who were over the age of 18 years with metastatic castration-resistant prostate cancer (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies and who had received prior taxane-based chemotherapy and androgen receptor (AR)-targeted therapy received once daily oral dose of 300 milligrams (mg) niraparib capsules starting Day 1 until disease progression, unacceptable toxicity, death, or termination of the study by the sponsor (up to 52 months).
Overall Number of Participants Analyzed		202
Measure Type: Number Unit of Measure: percentage of participants
BRCA	Number Analyzed	131 participants
BRCA		23.7
Non-BRCA	Number Analyzed	71 participants
Non-BRCA		8.5

4.Secondary Outcome


Title	Overall Survival (OS)
Description	OS is defined as time from enrollment to death from any cause.
Description	OS is defined as time from enrollment to death from any cause.
Time Frame	Up to 52 months

Outcome Measure Data

Analysis Population Description

ITT analysis set included participants who had received at least 1 dose of study drug. Here, 'n' (number analyzed) specifies the number of participants evaluated for specific categories.


Arm/Group Title		Niraparib
Arm/Group Description:		Male participants who were over the...
Arm/Group Description:		Male participants who were over the age of 18 years with metastatic castration-resistant prostate cancer (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies and who had received prior taxane-based chemotherapy and androgen receptor (AR)-targeted therapy received once daily oral dose of 300 milligrams (mg) niraparib capsules starting Day 1 until disease progression, unacceptable toxicity, death, or termination of the study by the sponsor (up to 52 months).
Overall Number of Participants Analyzed		223
Median (95% Confidence Interval) Unit of Measure: months
BRCA	Number Analyzed	142 participants
BRCA		13.01 (11.04 to 14.29)
Non-BRCA	Number Analyzed	81 participants
Non-BRCA		9.63 (8.05 to 13.44)

5.Secondary Outcome


Title	Radiographic Progression-Free Survival (rPFS)
Description	rPFS was defined as time from enrollment to radiographic progression o...
Description	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.
Time Frame	Up to 52 months

Outcome Measure Data

Analysis Population Description

ITT analysis set included participants who had received at least 1 dose of study drug. Here, 'n' (number analyzed) specifies the number of participants evaluated for specific categories.


Arm/Group Title		Niraparib
Arm/Group Description:		Male participants who were over the...
Arm/Group Description:		Male participants who were over the age of 18 years with metastatic castration-resistant prostate cancer (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies and who had received prior taxane-based chemotherapy and androgen receptor (AR)-targeted therapy received once daily oral dose of 300 milligrams (mg) niraparib capsules starting Day 1 until disease progression, unacceptable toxicity, death, or termination of the study by the sponsor (up to 52 months).
Overall Number of Participants Analyzed		223
Median (95% Confidence Interval) Unit of Measure: months
BRCA	Number Analyzed	142 participants
BRCA		8.08 (5.55 to 8.38)
Non-BRCA	Number Analyzed	81 participants
Non-BRCA		3.71 (1.97 to 5.49)

6.Secondary Outcome


Title	Time to Radiographic Progression
Description	Time to radiographic progression is defined as time from enrollment to...
Description	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.
Time Frame	Up to 52 months

Outcome Measure Data

Analysis Population Description

ITT analysis set included participants who had received at least 1 dose of study drug. Here, 'n' (number analyzed) specifies the number of participants evaluated for specific categories.


Arm/Group Title		Niraparib
Arm/Group Description:		Male participants who were over the...
Arm/Group Description:		Male participants who were over the age of 18 years with metastatic castration-resistant prostate cancer (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies and who had received prior taxane-based chemotherapy and androgen receptor (AR)-targeted therapy received once daily oral dose of 300 milligrams (mg) niraparib capsules starting Day 1 until disease progression, unacceptable toxicity, death, or termination of the study by the sponsor (up to 52 months).
Overall Number of Participants Analyzed		223
Median (95% Confidence Interval) Unit of Measure: months
BRCA	Number Analyzed	142 participants
BRCA		8.08 (5.75 to 8.97)
Non-BRCA	Number Analyzed	81 participants
Non-BRCA		3.78 (2.00 to 5.55)

7.Secondary Outcome


Title	Time to Prostate-Specific Antigen (PSA) Progression
Description	Time to PSA progression was defined as time from enrollment to the fir...
Description	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.
Time Frame	Up to 52 months

Outcome Measure Data

Analysis Population Description

ITT analysis set included participants who had received at least 1 dose of study drug. Here, 'n' (number analyzed) specifies the number of participants evaluated for specific categories.


Arm/Group Title		Niraparib
Arm/Group Description:		Male participants who were over the...
Arm/Group Description:		Male participants who were over the age of 18 years with metastatic castration-resistant prostate cancer (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies and who had received prior taxane-based chemotherapy and androgen receptor (AR)-targeted therapy received once daily oral dose of 300 milligrams (mg) niraparib capsules starting Day 1 until disease progression, unacceptable toxicity, death, or termination of the study by the sponsor (up to 52 months).
Overall Number of Participants Analyzed		223
Median (95% Confidence Interval) Unit of Measure: months
BRCA	Number Analyzed	142 participants
BRCA		5.13 (4.60 to 5.59)
Non-BRCA	Number Analyzed	81 participants
Non-BRCA		3.65 (2.83 to 3.71)

8.Secondary Outcome


Title	Time to Symptomatic Skeletal Event (SSE)
Description	Time to SSE was defined as the time from enrollment to first occurrenc...
Description	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.
Time Frame	Up to 52 months

Outcome Measure Data

Analysis Population Description

ITT analysis set included participants who had received at least 1 dose of study drug. Here, 'n' (number analyzed) specifies the number of participants evaluated for specific categories.


Arm/Group Title		Niraparib
Arm/Group Description:		Male participants who were over the...
Arm/Group Description:		Male participants who were over the age of 18 years with metastatic castration-resistant prostate cancer (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies and who had received prior taxane-based chemotherapy and androgen receptor (AR)-targeted therapy received once daily oral dose of 300 milligrams (mg) niraparib capsules starting Day 1 until disease progression, unacceptable toxicity, death, or termination of the study by the sponsor (up to 52 months).
Overall Number of Participants Analyzed		223
Median (95% Confidence Interval) Unit of Measure: months
BRCA	Number Analyzed	142 participants
BRCA		13.80 ^[1] (10.41 to NA)
Non-BRCA	Number Analyzed	81 participants
Non-BRCA		10.35 ^[1] (8.18 to NA)

[1]

Here, 'NA' indicates that upper limit of confidence interval was not estimable due to less number of events.

9.Secondary Outcome


Title	Duration of Objective Response
Description	Duration of objective response is defined as time from CR or PR to rad...
Description	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.
Time Frame	Up to 52 months

Outcome Measure Data

Analysis Population Description

Measurable ITT responder analysis set included all participants who received at least 1 dose of study drug, responded to it and have BRCA or non-BRCA and measurable disease at baseline. Here, 'n' (number analyzed) specifies the number of participants evaluated for specific categories.


Arm/Group Title		Niraparib
Arm/Group Description:		Male participants who were over the...
Arm/Group Description:		Male participants who were over the age of 18 years with metastatic castration-resistant prostate cancer (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies and who had received prior taxane-based chemotherapy and androgen receptor (AR)-targeted therapy received once daily oral dose of 300 milligrams (mg) niraparib capsules starting Day 1 until disease progression, unacceptable toxicity, death, or termination of the study by the sponsor (up to 52 months).
Overall Number of Participants Analyzed		31
Median (95% Confidence Interval) Unit of Measure: months
BRCA	Number Analyzed	26 participants
BRCA		5.55 (3.91 to 7.20)
non-BRCA	Number Analyzed	5 participants
non-BRCA		5.16 ^[1] (2.14 to NA)

[1]

Here, 'NA' indicates that upper limit of confidence interval was not estimable due to less number of events.

10.Secondary Outcome


Title	Number of Participants With Adverse Events (AEs)
Description	An AE is any untoward medical occurrence in a participant participatin...
Description	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.
Time Frame	Up to 52 months

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least 1 dose of study drug.


Arm/Group Title	Niraparib
Arm/Group Description:	Male participants who were over the...
Arm/Group Description:	Male participants who were over the age of 18 years with metastatic castration-resistant prostate cancer (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies and who had received prior taxane-based chemotherapy and androgen receptor (AR)-targeted therapy received once daily oral dose of 300 milligrams (mg) niraparib capsules starting Day 1 until disease progression, unacceptable toxicity, death, or termination of the study by the sponsor (up to 52 months).
Overall Number of Participants Analyzed	289
Measure Type: Count of Participants Unit of Measure: Participants
	288 99.7%

11.Secondary Outcome


Title	Number of Participants With Worst Toxicity Grades for Clinical Laboratory Tests Based on National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Description	Number of participants with worst toxicity grades for clinical laborat...
Description	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).
Time Frame	Up to 52 months

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least 1 dose of study drug and with at least one postbaseline assessment for the specific lab test within the time period. Here, 'n' (number analyzed) specifies the number of participants evaluated for specific categories.


Arm/Group Title		Niraparib
Arm/Group Description:		Male participants who were over the...
Arm/Group Description:		Male participants who were over the age of 18 years with metastatic castration-resistant prostate cancer (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies and who had received prior taxane-based chemotherapy and androgen receptor (AR)-targeted therapy received once daily oral dose of 300 milligrams (mg) niraparib capsules starting Day 1 until disease progression, unacceptable toxicity, death, or termination of the study by the sponsor (up to 52 months).
Overall Number of Participants Analyzed		283
Measure Type: Count of Participants Unit of Measure: Participants
ALT increased (Grade 1 or 2)	Number Analyzed	283 participants
ALT increased (Grade 1 or 2)		67 23.7%
ALT increased (Grade 3 or 4)	Number Analyzed	283 participants
ALT increased (Grade 3 or 4)		4 1.4%
Alkaline phosphatase increased (Grade 1 or 2)	Number Analyzed	283 participants
Alkaline phosphatase increased (Grade 1 or 2)		102 36.0%
Alkaline phosphatase increased (Grade 3 or 4)	Number Analyzed	283 participants
Alkaline phosphatase increased (Grade 3 or 4)		7 2.5%
AST increased (Grade 1 or 2)	Number Analyzed	283 participants
AST increased (Grade 1 or 2)		70 24.7%
AST increased (Grade 3 or 4)	Number Analyzed	283 participants
AST increased (Grade 3 or 4)		4 1.4%
Blood bilirubin increased (Grade 1 or 2)	Number Analyzed	283 participants
Blood bilirubin increased (Grade 1 or 2)		9 3.2%
Blood bilirubin increased (Grade 3 or 4)	Number Analyzed	283 participants
Blood bilirubin increased (Grade 3 or 4)		2 0.7%
Creatinine increased (Grade 1 or 2)	Number Analyzed	283 participants
Creatinine increased (Grade 1 or 2)		45 15.9%
Creatinine increased (Grade 3 or 4)	Number Analyzed	283 participants
Creatinine increased (Grade 3 or 4)		2 0.7%
GGT increased (Grade 1 or 2)	Number Analyzed	282 participants
GGT increased (Grade 1 or 2)		105 37.2%
GGT increased (Grade 3 or 4)	Number Analyzed	282 participants
GGT increased (Grade 3 or 4)		14 5.0%
Hemoglobin increased (Grade 1 or 2)	Number Analyzed	283 participants
Hemoglobin increased (Grade 1 or 2)		0 0.0%
Hemoglobin increased (Grade 3 or 4)	Number Analyzed	283 participants
Hemoglobin increased (Grade 3 or 4)		0 0.0%
Lymphocyte count increased (Grade 1 or 2)	Number Analyzed	283 participants
Lymphocyte count increased (Grade 1 or 2)		2 0.7%
Lymphocyte count increased (Grade 3 or 4)	Number Analyzed	283 participants
Lymphocyte count increased (Grade 3 or 4)		0 0.0%

Adverse Events

Time Frame	Up to 52 months
Adverse Event Reporting Description	Safety analysis set included all participants who received at least 1 dose of study drug.

Arm/Group Title	Niraparib
Arm/Group Description	Male participants who were over the...
Arm/Group Description	Male participants who were over the age of 18 years with metastatic castration-resistant prostate cancer (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies and who had received prior taxane-based chemotherapy and androgen receptor (AR)-targeted therapy received once daily oral dose of 300 milligrams (mg) niraparib capsules starting Day 1 until disease progression, unacceptable toxicity, death, or termination of the study by the sponsor (up to 52 months).
All-Cause Mortality
	Niraparib
	Affected / at Risk (%)
Total	208/289 (71.97%)
Serious Adverse Events Serious Adverse Events
	Niraparib
	Affected / at Risk (%)
Total	134/289 (46.37%)
Blood and lymphatic system disorders
Anaemia ^* 1	13/289 (4.50%)
Febrile Neutropenia ^* 1	2/289 (0.69%)
Leukopenia ^* 1	1/289 (0.35%)
Neutropenia ^* 1	1/289 (0.35%)
Thrombocytopenia ^* 1	17/289 (5.88%)
Cardiac disorders
Atrial Fibrillation ^* 1	1/289 (0.35%)
Cardiac Arrest ^* 1	1/289 (0.35%)
Cardiac Failure ^* 1	1/289 (0.35%)
Cardiac Failure Congestive ^* 1	1/289 (0.35%)
Ventricular Tachycardia ^* 1	1/289 (0.35%)
Gastrointestinal disorders
Abdominal Pain ^* 1	4/289 (1.38%)
Acute Abdomen ^* 1	1/289 (0.35%)
Ascites ^* 1	1/289 (0.35%)
Constipation ^* 1	5/289 (1.73%)
Diarrhoea ^* 1	2/289 (0.69%)
Gastritis ^* 1	2/289 (0.69%)
Gastrointestinal Haemorrhage ^* 1	1/289 (0.35%)
Inflammatory Bowel Disease ^* 1	1/289 (0.35%)
Lower Gastrointestinal Haemorrhage ^* 1	1/289 (0.35%)
Nausea ^* 1	5/289 (1.73%)
Rectal Haemorrhage ^* 1	1/289 (0.35%)
Small Intestinal Obstruction ^* 1	1/289 (0.35%)
Stomatitis ^* 1	2/289 (0.69%)
Volvulus ^* 1	1/289 (0.35%)
Vomiting ^* 1	7/289 (2.42%)
General disorders
Asthenia ^* 1	4/289 (1.38%)
Facial Pain ^* 1	1/289 (0.35%)
Fatigue ^* 1	4/289 (1.38%)
General Physical Health Deterioration ^* 1	8/289 (2.77%)
Non-Cardiac Chest Pain ^* 1	1/289 (0.35%)
Pain ^* 1	2/289 (0.69%)
Performance Status Decreased ^* 1	1/289 (0.35%)
Pyrexia ^* 1	4/289 (1.38%)
Systemic Inflammatory Response Syndrome ^* 1	1/289 (0.35%)
Infections and infestations
Abdominal Infection ^* 1	1/289 (0.35%)
Abscess Jaw ^* 1	1/289 (0.35%)
Cellulitis ^* 1	1/289 (0.35%)
Escherichia Urinary Tract Infection ^* 1	2/289 (0.69%)
Herpes Zoster ^* 1	1/289 (0.35%)
Infected Lymphocele ^* 1	1/289 (0.35%)
Infection ^* 1	1/289 (0.35%)
Lower Respiratory Tract Infection ^* 1	1/289 (0.35%)
Malaria ^* 1	1/289 (0.35%)
Neutropenic Sepsis ^* 1	1/289 (0.35%)
Osteomyelitis ^* 1	2/289 (0.69%)
Pneumocystis Jirovecii Pneumonia ^* 1	1/289 (0.35%)
Pneumonia ^* 1	4/289 (1.38%)
Pneumonia Haemophilus ^* 1	1/289 (0.35%)
Pyelonephritis Acute ^* 1	2/289 (0.69%)
Sepsis ^* 1	5/289 (1.73%)
Septic Shock ^* 1	2/289 (0.69%)
Skin Infection ^* 1	1/289 (0.35%)
Spinal Cord Infection ^* 1	1/289 (0.35%)
Urinary Tract Infection ^* 1	3/289 (1.04%)
Urosepsis ^* 1	2/289 (0.69%)
Injury, poisoning and procedural complications
Cystitis Radiation ^* 1	1/289 (0.35%)
Extradural Haematoma ^* 1	1/289 (0.35%)
Femur Fracture ^* 1	1/289 (0.35%)
Head Injury ^* 1	1/289 (0.35%)
Hip Fracture ^* 1	2/289 (0.69%)
Spinal Fracture ^* 1	1/289 (0.35%)
Investigations
Blood Calcium Increased ^* 1	1/289 (0.35%)
Blood Creatinine Increased ^* 1	1/289 (0.35%)
Electrocardiogram QT Prolonged ^* 1	1/289 (0.35%)
Metabolism and nutrition disorders
Dehydration ^* 1	4/289 (1.38%)
Hypercalcaemia ^* 1	1/289 (0.35%)
Hypocalcaemia ^* 1	1/289 (0.35%)
Hypokalaemia ^* 1	1/289 (0.35%)
Hyponatraemia ^* 1	2/289 (0.69%)
Hypophosphataemia ^* 1	1/289 (0.35%)
Hypovolaemia ^* 1	1/289 (0.35%)
Musculoskeletal and connective tissue disorders
Arthralgia ^* 1	3/289 (1.04%)
Back Pain ^* 1	7/289 (2.42%)
Bone Pain ^* 1	3/289 (1.04%)
Joint Effusion ^* 1	1/289 (0.35%)
Muscular Weakness ^* 1	3/289 (1.04%)
Musculoskeletal Pain ^* 1	1/289 (0.35%)
Myalgia ^* 1	1/289 (0.35%)
Pain in Extremity ^* 1	1/289 (0.35%)
Pain in Jaw ^* 1	1/289 (0.35%)
Pathological Fracture ^* 1	1/289 (0.35%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma ^* 1	1/289 (0.35%)
Gastrointestinal Stromal Tumour ^* 1	1/289 (0.35%)
Metastases to Meninges ^* 1	3/289 (1.04%)
Prostate Cancer Metastatic ^* 1	2/289 (0.69%)
Tumour Pain ^* 1	1/289 (0.35%)
Nervous system disorders
Altered State of Consciousness ^* 1	1/289 (0.35%)
Cauda Equina Syndrome ^* 1	1/289 (0.35%)
Cerebrovascular Accident ^* 1	1/289 (0.35%)
Headache ^* 1	6/289 (2.08%)
Ischaemic Stroke ^* 1	2/289 (0.69%)
Monoparesis ^* 1	1/289 (0.35%)
Nerve Compression ^* 1	1/289 (0.35%)
Neuropathy Peripheral ^* 1	1/289 (0.35%)
Paraparesis ^* 1	1/289 (0.35%)
Presyncope ^* 1	1/289 (0.35%)
Spinal Cord Compression ^* 1	6/289 (2.08%)
Syncope ^* 1	2/289 (0.69%)
Transient Ischaemic Attack ^* 1	1/289 (0.35%)
Psychiatric disorders
Confusional State ^* 1	2/289 (0.69%)
Renal and urinary disorders
Acute Kidney Injury ^* 1	2/289 (0.69%)
Haematuria ^* 1	6/289 (2.08%)
Renal Impairment ^* 1	1/289 (0.35%)
Urinary Retention ^* 1	2/289 (0.69%)
Reproductive system and breast disorders
Prostatitis ^* 1	1/289 (0.35%)
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure ^* 1	1/289 (0.35%)
Chronic Obstructive Pulmonary Disease ^* 1	1/289 (0.35%)
Dyspnoea ^* 1	1/289 (0.35%)
Lung Disorder ^* 1	1/289 (0.35%)
Pneumonitis ^* 1	1/289 (0.35%)
Pulmonary Embolism ^* 1	1/289 (0.35%)
Respiratory Distress ^* 1	1/289 (0.35%)
Vascular disorders
Deep Vein Thrombosis ^* 1	1/289 (0.35%)
Embolism ^* 1	1/289 (0.35%)
Hypotension ^* 1	2/289 (0.69%)
Phlebitis ^* 1	1/289 (0.35%)
1 Term from vocabulary, MedDRA Version 23.0 * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Niraparib
	Affected / at Risk (%)
Total	280/289 (96.89%)
Blood and lymphatic system disorders
Anaemia ^* 1	154/289 (53.29%)
Leukopenia ^* 1	27/289 (9.34%)
Lymphopenia ^* 1	24/289 (8.30%)
Neutropenia ^* 1	54/289 (18.69%)
Thrombocytopenia ^* 1	94/289 (32.53%)
Gastrointestinal disorders
Abdominal Pain ^* 1	23/289 (7.96%)
Constipation ^* 1	98/289 (33.91%)
Diarrhoea ^* 1	48/289 (16.61%)
Dry Mouth ^* 1	20/289 (6.92%)
Dyspepsia ^* 1	21/289 (7.27%)
Nausea ^* 1	167/289 (57.79%)
Stomatitis ^* 1	19/289 (6.57%)
Vomiting ^* 1	109/289 (37.72%)
General disorders
Asthenia ^* 1	45/289 (15.57%)
Fatigue ^* 1	105/289 (36.33%)
Oedema Peripheral ^* 1	41/289 (14.19%)
Pyrexia ^* 1	17/289 (5.88%)
Investigations
Alanine Aminotransferase Increased ^* 1	17/289 (5.88%)
Aspartate Aminotransferase Increased ^* 1	20/289 (6.92%)
Blood Alkaline Phosphatase Increased ^* 1	26/289 (9.00%)
Electrocardiogram QT Prolonged ^* 1	17/289 (5.88%)
Gamma-Glutamyltransferase Increased ^* 1	25/289 (8.65%)
Weight Decreased ^* 1	50/289 (17.30%)
Metabolism and nutrition disorders
Decreased Appetite ^* 1	93/289 (32.18%)
Musculoskeletal and connective tissue disorders
Arthralgia ^* 1	43/289 (14.88%)
Back Pain ^* 1	59/289 (20.42%)
Bone Pain ^* 1	30/289 (10.38%)
Musculoskeletal Pain ^* 1	29/289 (10.03%)
Pain in Extremity ^* 1	30/289 (10.38%)
Nervous system disorders
Dizziness ^* 1	19/289 (6.57%)
Dysgeusia ^* 1	17/289 (5.88%)
Headache ^* 1	30/289 (10.38%)
Psychiatric disorders
Insomnia ^* 1	24/289 (8.30%)
Respiratory, thoracic and mediastinal disorders
Cough ^* 1	17/289 (5.88%)
Dyspnoea ^* 1	39/289 (13.49%)
Vascular disorders
Hot Flush ^* 1	17/289 (5.88%)
Hypertension ^* 1	34/289 (11.76%)
1 Term from vocabulary, MedDRA Version 23.0 * Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	EXECUTIVE MEDICAL DIRECTOR
Organization:	Janssen Research & Development, LLC
Phone:	844-434-4210
EMail:	ClinicalTrialDisclosure@its.jnj.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Layout table for additonal information

Responsible Party:	Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:	NCT02854436
Other Study ID Numbers:	CR108208 64091742PCR2001 ( Other Identifier: Janssen Research & Development, LLC ) 2016-002057-38 ( EudraCT Number )
First Submitted:	August 1, 2016
First Posted:	August 3, 2016
Results First Submitted:	January 25, 2022
Results First Posted:	March 8, 2022
Last Update Posted:	November 13, 2023

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