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A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer (QUEST)

Primary Purpose

Prostatic Neoplasms, Castration-Resistant

Status

Active

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Niraparib 200 mg

Cetrelimab 240 mg

Cetrelimab 480 mg

Abiraterone acetate 1000 mg

Prednisone 5 mg

About this trial

This is an interventional treatment trial for Prostatic Neoplasms, Castration-Resistant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria for Combination 3:

Diagnosed with mCRPC, who in the opinion of the investigator may benefit from treatment in Combination 3 of this study
Able to continue gonadotropin releasing hormone analogue (GnRHa) therapy during the study if not surgically castrate (that is, subjects who has not undergone bilateral orchiectomy).
Eastern Cooperative Oncology Group Performance Status (ECOG PS) of less than or equal to (<=) 1
Toxicity associated with prior chemotherapy or radiotherapy has resolved to Grade <= 1 (except alopecia or Grade <= 2 neuropathy) at screening
Participant must agree not to donate sperm while on study treatment, and for 3 months following the last dose of study treatment

Exclusion Criteria:

History or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)
Active malignancies (that is, progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. The only allowed exceptions are: non-muscle invasive bladder cancer; skin cancer (non-melanoma or melanoma); breast cancer; malignancy that is considered cured with minimal risk of recurrence
Active infection requiring systemic therapy
Allergies, hypersensitivity, or intolerance to niraparib or the corresponding excipients

Combination 3:

Symptomatic brain metastases
Prior disease progression during combination treatment with AA and poly (adenosine diphosphate [ADP]-ribose) polymerase inhibitor (PARPi). Prior discontinuation of treatment with AA or PARPi due to AA- or PARPi-related toxicity

Sites / Locations

Urological Associates of Southern Arizona, P.C.
The Urology Center of Colorado
Mayo Clinic - Division Of Hematology/oncology
First Urology, PSC
Chesapeake Urology Research Associates
Michigan Institute of Urology
New York Oncology Hematology
Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
Thomas Jefferson University
University of Pittsburgh Medical Center (UPMC)
MUSC-Hollings Cancer Center
Carolina Urologic Research Center
Urology Associates
Houston Metro Urology
The University of Texas MD Anderson Cancer Center
Utah Cancer Specialists
Urology of Virginia, PLCC
University of Wisconsin Carbone Cancer Center
OLV Ziekenhuis Aalst
ZNA Middelheim
ULB Hôpital Erasme
Universitair Ziekenhuis Gent
Az Groeninge
Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
Southern Alberta Institute of Urology / Prostate Cancer Centre
British Columbia Cancer Agency
University Health Network (UHN) Princess Margaret Cancer Centre
Centre de Recherche du CHUM
Asaf Harofe Medical Center
Soroka Hospital
Rambam Medical Center
Rabin Medical Center
Sheba Medical Center Tel Hashomer
Azienda Ospedaliera Universitaria Careggi di Firenze
Azienda Ospedaliera ''Vito Fazzi''
UOC Oncologia Ospedale Provinciale di Macerata
ASST Grande Ospedale Metropolitano Niguarda
IRCCS-Fondazione Pascale
Hosp. de La Santa Creu I Sant Pau
Hospital Vall D'Hebron
Hosp. Univ. de La Princesa
Hosp. Univ. Fund. Jimenez Diaz
Hosp. Univ. Hm Sanchinarro
Hosp. Virgen de La Victoria
Royal United Hospital
University College London Hospitals
Southampton General Hospital
The Royal Marsden NHS Trust Sutton
Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Combination 1:Dose Selection: Niraparib + cetrelimab (Part 1)

Combination 1:Dose Expansion: Niraparib + cetrelimab (Part 2)

Combination 2: Dose Expansion: Niraparib + AA-P (Part 2)

Combination 3: Niraparib + AA-P

Arm Description

Dose regimen 1: The participants will receive niraparib 200 milligram (mg) orally once daily in combination with cetrelimab 240 mg intravenously (IV) once every 2 weeks. Dose regimen 2: The participants will receive niraparib 200 mg orally once daily in combination with cetrelimab 480 mg IV once every 4 weeks in 28-day treatment cycles until disease progression, unacceptable toxicity, death, or the sponsor terminates the study. The safety evaluation team (SET) will determine if an additional cohort is necessary, based on the data from dose regimens 1 and 2. Participants in the Treatment Phase of this combination will be offered the option to enter the Long-term Extension Phase of the study.

Participants will be assigned to either Cohort 1A (Biomarker [BM] positive [+]) or Cohort 1B (BM negative [-]) and will receive established RP2D of cetrelimab and niraparib, in Part 2 until disease progression, unacceptable toxicity, death, or the sponsor terminates the study. A futility analysis will be performed for the Cohort 1B after 10 BM- participants are enrolled in Part 2. This cohort will be closed if the response is less than predetermined response rate as outlined in the protocol. Participants in the Treatment Phase of this combination will be offered the option to enter the Long-term Extension Phase of the study.

Participants will be assigned to one of 4 cohorts based on biomarker status - Cohort 2A (BRCA biallelic loss), 2B (other DRD biallelic loss), 2C (BRCA monoallelic loss), or 2D (other DRD monoallelic loss), and will receive niraparib 200 mg once daily in combination with abiraterone acetate 1000 mg (4*250 mg) plus 10 mg prednisone (5 mg twice daily) throughout treatment phase. Participants in the Treatment Phase of this combination will be offered the option to enter the Long-term Extension Phase of the study.

Participants will be assigned to one of three cohorts to receive AA-P with or without niraparib. Participants in the Treatment Phase of this combination will be offered the option to enter the Long-term Extension Phase of the study.

Outcomes

Primary Outcome Measures

Part 1: Combination 1: Incidence of Specified Toxicities

Incidence defined as number of participants with specified toxicities will be reported. The dose will be considered intolerable if a participant developed Grade greater than or equal to (>=) 3 non-hematological toxicity (with exceptions including anorexia, fever, constipation, fatigue that improves to Grade less than or equal to (<=) 2 in <=7 days, vomiting and diarrhea that resolves in <=3 days with best supportive care), treatment-related Grade 4 thrombocytopenia or Grade >= 3 thrombocytopenia, treatment-related Grade 4 neutropenia >= 7 days, or Grade 3 or 4 neutropenia, treatment-related serious adverse events.

Part 2: Combination 1: Objective Response Rate (ORR)

Objective response rate is defined as the percentage of participants who achieve complete response (CR) or partial response (PR), as assessed by response evaluation criteria in solid tumors (RECIST) 1.1 criteria with no evidence of bone progression according to prostate cancer working group 3 (PCWG3) criteria.

Part 2: Combinations 1: Incidence of Adverse Events (AEs)

Incidence defined as number of participants with AEs will be reported. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

Part 2: Combinations 1: Severity of Adverse Events

Any AE not listed in the NCI-CTCAE will be graded according to the investigator's clinical judgment using the standard grades.

Part 2: Combination 2: Composite Response Rate (RR)

Composite response rate (RR) is defined as percentage of participants who have 1 of the following by PCWG3 criteria: Objective response (confirmed per RECIST 1.1), or circulating tumor cells (CTC) response: defined as CTC=0 per 7.5 milliliter (mL) of blood at 8 weeks for participants who have CTC greater than or equal to (>=)1 at baseline or CTC less than (<)5 per 7.5 mL with CTC >=5 at baseline, confirmed by a second consecutive value obtained 4 or more weeks later, or prostate-specific antigen (PSA) decline of >=50%, measured twice 3 to 4 weeks apart.

Combination 3: Maximum Observed Analyte Plasma Concentration (Cmax) of Niraparib and AA After a Single Dose

Cmax is defined as the maximum observed plasma concentration.

Combination 3: Maximum Observed Analyte Plasma Concentration for Niraparib Normalized by the Dose (Cmax/dose) of Niraparib and AA After a Single Dose

Cmax/dose is defined as maximum observed analyte plasma concentration for niraparib normalized by the dose.

Combination 3: Area Under the Plasma Concentration-Time Curve from Time Zero to 168 Hours (AUC [0-168]) of Niraparib and AA After a Single Dose

AUC (0-168) is defined as area under plasma concentration-time curve from time 0 to time 168 hours post dosing.

Combination 3: Area Under the Plasma Concentration-Time Curve for Niraparib from Time Zero to 168 Hours (AUC [0-168]/dose) of Niraparib and AA After a Single Dose

AUC (0-168)/dose is defined as area under plasma concentration-time curve for niraparib from time 0 to time 168 hours post dosing.

Secondary Outcome Measures

Part 2: Combination 1: Number of Participants with Circulating Tumor Cell (CTC) Response

CTC response is defined as CTC=0 per 7.5 milliliter (mL) of blood at 8 weeks for participants who have CTC >= 1 at baseline or CTC<5 per 7.5 mL with CTC >=5 at baseline, confirmed by a second consecutive value obtained 4 or more weeks later.

Part 2: Combination 1: Composite Response Rate (RR)

Composite RR is defined as percentage of participants who have 1 of the following by PCWG3: Objective response (confirmed per RECIST 1.1), or CTC response: defined as CTC=0 per 7.5 mL of blood at 8 weeks for participants who have CTC >=1 at baseline or CTC <5 baseline per 7.5 mL with CTC>5 at baseline, confirmed by a second consecutive value obtained 4 or more weeks later, or PSA decline of >= 50%, measured twice 3 to 4 weeks apart.

Part 2: Combination 1: Duration of Objective Response

Duration of objective response is defined as time from complete response (CR) or partial response (PR) to radiographic progression of disease (PD), unequivocal clinical progression, or death, whichever occurs first. CR defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to less than 10 millimeter (mm). PR defined as at least 30 % decrease in sum of the diameters of the target lesions taking as reference the baseline sum diameters. PD is defined as a 20% increase in the sum of diameters of all target lesions and a minimum absolute increase of 5 mm in the sum.

Part 2: Combination 1: Overall Survival (OS)

OS is defined as time from start of treatment to death from any cause.

Part 2: Combination 2: Objective Response Rate (ORR)

ORR of soft tissue (visceral or nodal disease) as defined by RECIST 1.1 with no evidence of bone progression according to PCWG3 criteria. As per RECIST 1.1 criteria, ORR is defined as the percentage of participants who achieve complete response (CR) or partial response (PR), as assessed by response evaluation criteria in solid tumors (RECIST) 1.1 criteria with no evidence of bone progression according to prostate cancer working group 3 (PCWG3) criteria. CR defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to less than 10 millimeter (mm). PR defined as at least 30 percent (%) decrease in sum of the diameters of the target lesions taking as reference the baseline sum diameters.

Combination 3: Number of Participants with Adverse Events

Number of participants with adverse events will be reported.

Combination 3: Number of Participants with Abnormal Clinical Laboratory Findings

Number of participants with abnormal clinical laboratory findings (hematology and serum chemistry) will be reported.

Full Information

NCT ID

NCT03431350

First Posted

February 6, 2018

Last Updated

August 15, 2023

Sponsor

Janssen Research & Development, LLC

1. Study Identification

Unique Protocol Identification Number

NCT03431350

Brief Title

A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer

Acronym

QUEST

Official Title

A Phase 1b-2 Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

March 2, 2018 (Actual)

Primary Completion Date

August 31, 2021 (Actual)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to: a) establish the recommended phase 2 dose (RP2D) and to evaluate the antitumor activity and safety of niraparib combination therapies (Combinations 1 and 2) and b) to determine the relative bioavailability of niraparib and abiraterone acetate (AA) in combination (Combination 3) in participants with metastatic castration-resistant prostate cancer (mCRPC).

Detailed Description

This multicenter study will evaluate safety and efficacy of niraparib in combination with other anti-cancer agents. Combination 1 will combine niraparib with the anti-programmed cell death protein (PD)-1 monoclonal antibody cetrelimab, in participants with mCRPC. Combination 1 has 2 parts: in Part 1 (dose selection), participants will be enrolled to establish RP2D doses of niraparib and cetrelimab; and Part 2 (dose expansion) will evaluate the combination therapy in an expanded number of participants into 2 cohorts (biomarker positive or biomarker negative). Combination 2 will combine niraparib with abiraterone acetate plus prednisone (AA-P) in mCRPC participants with DNA-repair gene defects (DRD). Combination 3 will evaluate the relative bioavailability (BA) of niraparib and AA in combination. In a pharmacokinetics (PK) assessment phase, niraparib and AA will be administered, and in an extension phase, niraparib and AA-P will be administered. Combinations 1 and 2 will have 5 phases: A Pre-screening Phase, a Screening Phase, a Treatment Phase, a Follow-up Phase, and a Long-term Extension (LTE) Phase; Combination 3 has 3 phases: A Screening Phase, A PK Assessment Phase, an Extension Phase (including LTE phase). Study evaluations will include efficacy, PK, PK/pharmacodynamics, biomarkers, safety and tolerability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostatic Neoplasms, Castration-Resistant

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

136 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Combination 1:Dose Selection: Niraparib + cetrelimab (Part 1)

Arm Type

Experimental

Arm Description

Arm Title

Combination 1:Dose Expansion: Niraparib + cetrelimab (Part 2)

Arm Type

Experimental

Arm Description

Arm Title

Combination 2: Dose Expansion: Niraparib + AA-P (Part 2)

Arm Type

Experimental

Arm Description

Arm Title

Combination 3: Niraparib + AA-P

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Niraparib 200 mg

Intervention Description

Participants will receive niraparib 200 mg orally.

Intervention Type

Drug

Intervention Name(s)

Cetrelimab 240 mg

Other Intervention Name(s)

JNJ-63723283

Intervention Description

Participants will receive cetrelimab 240 mg IV every 2 weeks.

Intervention Type

Drug

Intervention Name(s)

Cetrelimab 480 mg

Other Intervention Name(s)

JNJ-63723283

Intervention Description

Participants will receive cetrelimab 480 mg IV every 4 weeks.

Intervention Type

Drug

Intervention Name(s)

Abiraterone acetate 1000 mg

Intervention Description

Participants will receive AA 1000 mg orally.

Intervention Type

Drug

Intervention Name(s)

Prednisone 5 mg

Intervention Description

Participants will receive prednisone 5 mg orally.

Primary Outcome Measure Information:

Title

Part 1: Combination 1: Incidence of Specified Toxicities

Description

Time Frame

Up to Day 28

Title

Part 2: Combination 1: Objective Response Rate (ORR)

Description

Time Frame

Up to 42 months

Title

Part 2: Combinations 1: Incidence of Adverse Events (AEs)

Description

Time Frame

Up to 42 months

Title

Part 2: Combinations 1: Severity of Adverse Events

Description

Any AE not listed in the NCI-CTCAE will be graded according to the investigator's clinical judgment using the standard grades.

Time Frame

Up to 42 months

Title

Part 2: Combination 2: Composite Response Rate (RR)

Description

Time Frame

Up to 42 months

Title

Combination 3: Maximum Observed Analyte Plasma Concentration (Cmax) of Niraparib and AA After a Single Dose

Description

Cmax is defined as the maximum observed plasma concentration.

Time Frame

Up to 168 hours postdose

Title

Combination 3: Maximum Observed Analyte Plasma Concentration for Niraparib Normalized by the Dose (Cmax/dose) of Niraparib and AA After a Single Dose

Description

Cmax/dose is defined as maximum observed analyte plasma concentration for niraparib normalized by the dose.

Time Frame

Up to 168 hours postdose

Title

Combination 3: Area Under the Plasma Concentration-Time Curve from Time Zero to 168 Hours (AUC [0-168]) of Niraparib and AA After a Single Dose

Description

AUC (0-168) is defined as area under plasma concentration-time curve from time 0 to time 168 hours post dosing.

Time Frame

Up to 168 hours postdose

Title

Combination 3: Area Under the Plasma Concentration-Time Curve for Niraparib from Time Zero to 168 Hours (AUC [0-168]/dose) of Niraparib and AA After a Single Dose

Description

AUC (0-168)/dose is defined as area under plasma concentration-time curve for niraparib from time 0 to time 168 hours post dosing.

Time Frame

Up to 168 hours postdose

Secondary Outcome Measure Information:

Title

Part 2: Combination 1: Number of Participants with Circulating Tumor Cell (CTC) Response

Description

Time Frame

Up to 42 months

Title

Part 2: Combination 1: Composite Response Rate (RR)

Description

Time Frame

Up to 42 months

Title

Part 2: Combination 1: Duration of Objective Response

Description

Time Frame

Up to 42 months

Title

Part 2: Combination 1: Overall Survival (OS)

Description

OS is defined as time from start of treatment to death from any cause.

Time Frame

Up to 46 months

Title

Part 2: Combination 2: Objective Response Rate (ORR)

Description

Time Frame

Up to 42 months

Title

Combination 3: Number of Participants with Adverse Events

Description

Number of participants with adverse events will be reported.

Time Frame

Up to 46 months

Title

Combination 3: Number of Participants with Abnormal Clinical Laboratory Findings

Description

Number of participants with abnormal clinical laboratory findings (hematology and serum chemistry) will be reported.

Time Frame

Up to 46 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria for Combination 3: Diagnosed with mCRPC, who in the opinion of the investigator may benefit from treatment in Combination 3 of this study Able to continue gonadotropin releasing hormone analogue (GnRHa) therapy during the study if not surgically castrate (that is, subjects who has not undergone bilateral orchiectomy). Eastern Cooperative Oncology Group Performance Status (ECOG PS) of less than or equal to (<=) 1 Toxicity associated with prior chemotherapy or radiotherapy has resolved to Grade <= 1 (except alopecia or Grade <= 2 neuropathy) at screening Participant must agree not to donate sperm while on study treatment, and for 3 months following the last dose of study treatment Exclusion Criteria: History or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) Active malignancies (that is, progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. The only allowed exceptions are: non-muscle invasive bladder cancer; skin cancer (non-melanoma or melanoma); breast cancer; malignancy that is considered cured with minimal risk of recurrence Active infection requiring systemic therapy Allergies, hypersensitivity, or intolerance to niraparib or the corresponding excipients Combination 3: Symptomatic brain metastases Prior disease progression during combination treatment with AA and poly (adenosine diphosphate [ADP]-ribose) polymerase inhibitor (PARPi). Prior discontinuation of treatment with AA or PARPi due to AA- or PARPi-related toxicity

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janssen Research & Development, LLC Clinical Trial

Organizational Affiliation

Janssen Research & Development, LLC

Official's Role

Study Director

Facility Information:

Facility Name

Urological Associates of Southern Arizona, P.C.

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85741

Country

United States

Facility Name

The Urology Center of Colorado

City

Denver

State/Province

Colorado

ZIP/Postal Code

80211

Country

United States

Facility Name

Mayo Clinic - Division Of Hematology/oncology

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32224

Country

United States

Facility Name

First Urology, PSC

City

Jeffersonville

State/Province

Indiana

ZIP/Postal Code

47130

Country

United States

Facility Name

Chesapeake Urology Research Associates

City

Towson

State/Province

Maryland

ZIP/Postal Code

21204

Country

United States

Facility Name

Michigan Institute of Urology

City

Troy

State/Province

Michigan

ZIP/Postal Code

48084

Country

United States

Facility Name

New York Oncology Hematology

City

Albany

State/Province

New York

ZIP/Postal Code

12208

Country

United States

Facility Name

Memorial Sloan Kettering Cancer Center

City

Harrison

State/Province

New York

ZIP/Postal Code

10604

Country

United States

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

Thomas Jefferson University

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Name

University of Pittsburgh Medical Center (UPMC)

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15232

Country

United States

Facility Name

MUSC-Hollings Cancer Center

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

Carolina Urologic Research Center

City

Myrtle Beach

State/Province

South Carolina

ZIP/Postal Code

29572

Country

United States

Facility Name

Urology Associates

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37209

Country

United States

Facility Name

Houston Metro Urology

City

Houston

State/Province

Texas

ZIP/Postal Code

77027

Country

United States

Facility Name

The University of Texas MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Utah Cancer Specialists

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84106

Country

United States

Facility Name

Urology of Virginia, PLCC

City

Virginia Beach

State/Province

Virginia

ZIP/Postal Code

23462

Country

United States

Facility Name

University of Wisconsin Carbone Cancer Center

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

5379200

Country

United States

Facility Name

OLV Ziekenhuis Aalst

City

Aalst

ZIP/Postal Code

9300

Country

Belgium

Facility Name

ZNA Middelheim

City

Antwerpen

ZIP/Postal Code

2020

Country

Belgium

Facility Name

ULB Hôpital Erasme

City

Brussels

ZIP/Postal Code

1070

Country

Belgium

Facility Name

Universitair Ziekenhuis Gent

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Az Groeninge

City

Kortrijk

ZIP/Postal Code

8500

Country

Belgium

Facility Name

Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman

City

Liege

ZIP/Postal Code

B-4000

Country

Belgium

Facility Name

Southern Alberta Institute of Urology / Prostate Cancer Centre

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2V 1P9

Country

Canada

Facility Name

British Columbia Cancer Agency

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z4E6

Country

Canada

Facility Name

University Health Network (UHN) Princess Margaret Cancer Centre

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

Centre de Recherche du CHUM

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2X 0A9

Country

Canada

Facility Name

Asaf Harofe Medical Center

City

Beer Yaakov

ZIP/Postal Code

60930

Country

Israel

Facility Name

Soroka Hospital

City

Beer-Sheva

ZIP/Postal Code

85101

Country

Israel

Facility Name

Rambam Medical Center

City

Haifa

ZIP/Postal Code

31096

Country

Israel

Facility Name

Rabin Medical Center

City

Petach Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

Sheba Medical Center Tel Hashomer

City

Ramat Gan

ZIP/Postal Code

52621

Country

Israel

Facility Name

Azienda Ospedaliera Universitaria Careggi di Firenze

City

Firenze

ZIP/Postal Code

50134

Country

Italy

Facility Name

Azienda Ospedaliera ''Vito Fazzi''

City

Lecce

ZIP/Postal Code

73100

Country

Italy

Facility Name

UOC Oncologia Ospedale Provinciale di Macerata

City

Macerata

ZIP/Postal Code

62100

Country

Italy

Facility Name

ASST Grande Ospedale Metropolitano Niguarda

City

Milano

ZIP/Postal Code

20162

Country

Italy

Facility Name

IRCCS-Fondazione Pascale

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Hosp. de La Santa Creu I Sant Pau

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Facility Name

Hospital Vall D'Hebron

City

Barcelona

ZIP/Postal Code

8035

Country

Spain

Facility Name

Hosp. Univ. de La Princesa

City

Madrid

ZIP/Postal Code

28006

Country

Spain

Facility Name

Hosp. Univ. Fund. Jimenez Diaz

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Hosp. Univ. Hm Sanchinarro

City

Madrid

ZIP/Postal Code

28050

Country

Spain

Facility Name

Hosp. Virgen de La Victoria

City

Malaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

Royal United Hospital

City

Bath

ZIP/Postal Code

BA1 3NG

Country

United Kingdom

Facility Name

University College London Hospitals

City

London

ZIP/Postal Code

WC1E 6BT

Country

United Kingdom

Facility Name

Southampton General Hospital

City

Southampton

ZIP/Postal Code

SO16 6YD

Country

United Kingdom

Facility Name

The Royal Marsden NHS Trust Sutton

City

Sutton

ZIP/Postal Code

SM2 5PT

Country

United Kingdom

Facility Name

Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital

City

Truro

ZIP/Postal Code

TR1 3LJ

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer

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