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Study of Olaparib (Lynparza™) Versus Enzalutamide or Abiraterone Acetate in Men With Metastatic Castration-Resistant Prostate Cancer (PROfound Study)

Primary Purpose

Metastatic Castration-resistant Prostate Cancer

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

olaparib

enzalutamide

abiraterone acetate

enzalutamide

About this trial

This is an interventional treatment trial for Metastatic Castration-resistant Prostate Cancer focused on measuring metastatic castration-resistant prostate cancer (mCRPC), homologous recombination repair (HRR)

Eligibility Criteria

18 Years - 130 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion criteria

Histologically confirmed diagnosis of prostate cancer.
Documented evidence of metastatic castration resistant prostate cancer (mCRPC).
Subjects must have progressed on prior new hormonal agent (e.g. abiraterone acetate and/or enzalutamide) for the treatment of metastatic prostate cancer and/or CRPC .
Ongoing therapy with LHRH analog or bilateral orchiectomy.
Radiographic progression at study entry while on androgen deprivation therapy (or after bilateral orchiectomy).
Qualifying HRR mutation in tumor tissue.

Exclusion criteria

Any previous treatment with PARP inhibitor, including olaparib.
Subjects who have any previous treatment with DNA-damaging cytotoxic chemotherapy, except if for non-prostate cancer indication and last dose > 5 years prior to randomization.
Other malignancy (including MDS and MGUS) within the last 5 years except: adequately treated non-melanoma skin cancer or other solid tumors curatively treated with no evidence of disease for ≥5 years.
Subjects with known brain metastases.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Olaparib

Enzalutamide OR abiraterone acetate

Arm Description

Olaparib is available as a film-coated tablet containing 150 mg or 100 mg of olaparib. Subjects will be administered study treatment orally at a dose of 300 mg twice daily (bid). The planned dose of 300 mg bid will be made up of two x 150 mg tablets twice daily, with 100 mg tablets used to manage dose reductions

Enzalutamide: Enzalutamide is available as capsules or tablets containing 40 mg of enzalutamide. Subjects will be administered study treatment orally at a dose of 160 mg once daily. Abiraterone acetate with prednisone: Abiraterone acetate is available as tablets containing 250 mg or 500 mg of abiraterone acetate. Subjects will be administered study treatment orally at a dose of 1,000 mg once daily in combination with prednisone 5 mg administered twice daily orally. Prednisolone is permitted for use instead of prednisone if necessary.

Outcomes

Primary Outcome Measures

Radiological Progression Free Survival (rPFS) by Blinded Independent Central Review (BICR) - Cohort A Only

The time from randomisation until the date of objective radiological disease progression (determined by RECIST 1.1 (soft tissue) and Prostate Cancer Working Group 3 (PCWG-3) (bone)) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from randomised therapy or received another anti-cancer therapy prior to progression. Progression is defined using (i) Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for soft tissue, as a >=20% increase in the sum of diameters of target lesions and an absolute increase of >=5mm taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters; (ii) Prostate Cancer Working Group 3 (PGWG-3) for bone as >= 2 new bone lesions on the 1st week 8 scan compared to baseline. The confirmatory scan, >=6 weeks later, must show >=2 more new bone lesions (for a total of >=4 new bone lesions since baseline).

Secondary Outcome Measures

Confirmed Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) - Cohort A Only

ORR is the percentage of patients with at least one visit response of Complete response (CR) or Partial response (PR), in their soft tissue disease assessed by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), in the absence of progression on bone scan assessed by Prostate Cancer Working Group 3 (PCWG3)). Per RECIST v1.1, CR=Disappearance of all target lesions; PR = >=30% decrease in the sum of diameters of target lesions; For each treatment group, ORR is the number of patients with a CR and PR.

Radiological Progression Free Survival (rPFS) by Blinded Independent Central Review (BICR) - Cohort A+B

The time from randomisation until the date of objective radiological disease progression (by RECIST 1.1 and Prostate Cancer Working Group 3 (PGWG-3)) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from randomised therapy or received another anti-cancer therapy prior to progression.

Time to Pain Progression - Cohort A Only

Time from randomisation to time point at which worsening in pain is observed (ie date of pain progression - date of randomisation + 1). Based on average Brief Pain Inventory - short form (BPI-SF) worst pain [Item 3] and Analgesic Quantification Algorithm [AQA] score.

Overall Survival (OS) - Cohort A Only

Number of Participants with Overall Survival (OS) - Cohort A only.

Full Information

NCT ID

NCT02987543

First Posted

November 15, 2016

Last Updated

October 4, 2023

Sponsor

AstraZeneca

Collaborators

Merck Sharp & Dohme LLC, Foundation Medicine, Inc., Myriad Genetics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02987543

Brief Title

Study of Olaparib (Lynparza™) Versus Enzalutamide or Abiraterone Acetate in Men With Metastatic Castration-Resistant Prostate Cancer (PROfound Study)

Official Title

A Phase III, Open Label, Randomized Study to Assess the Efficacy and Safety of Olaparib (Lynparza™) Versus Enzalutamide or Abiraterone Acetate in Men With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Prior Treatment With a New Hormonal Agent and Have Homologous Recombination Repair Gene Mutations (PROfound)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

February 6, 2017 (Actual)

Primary Completion Date

June 4, 2019 (Actual)

Study Completion Date

February 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

Collaborators

Merck Sharp & Dohme LLC, Foundation Medicine, Inc., Myriad Genetics, Inc.

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 evaluate the efficacy and safety of olaparib versus enzalutamide or abiraterone acetate in subjects with metastatic castration-resistant prostate cancer who have failed prior treatment with a new hormonal agent and have homologous recombination repair gene mutations.

Detailed Description

This is a prospective, multicenter, randomized, open-label, phase 3 trial evaluating the efficacy and safety of olaparib versus enzalutamide or abiraterone in subjects with metastatic castration-resistant prostate cancer (mCRPC) who have failed prior treatment with a new hormonal agent (NHA) and have a qualifying tumor mutation in one of 15 genes involved in the homologous recombination repair (HRR) pathway. Subjects will be divided into two cohorts based on HRR gene mutation status. Approximately 340 subjects will be randomized 2:1 (olaparib : investigator choice of enzalutamide or abiraterone acetate) into the trial.

6. Conditions and Keywords

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

Metastatic Castration-resistant Prostate Cancer

Keywords

metastatic castration-resistant prostate cancer (mCRPC), homologous recombination repair (HRR)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

387 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Olaparib

Arm Type

Experimental

Arm Description

Arm Title

Enzalutamide OR abiraterone acetate

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

olaparib

Other Intervention Name(s)

Lynparza

Intervention Description

300 mg (2x 150 mg tablets) twice daily

Intervention Type

Drug

Intervention Name(s)

enzalutamide

Other Intervention Name(s)

XTANDI

Intervention Description

160 mg (4 x 40 mg capsules) once daily

Intervention Type

Drug

Intervention Name(s)

abiraterone acetate

Other Intervention Name(s)

ZYTIGA

Intervention Description

1,000 mg (4 x 250 mg tablets) once daily

Intervention Type

Drug

Intervention Name(s)

abiraterone acetate

Other Intervention Name(s)

ZYTIGA

Intervention Description

1,000 mg (2 x 500 mg tablets) once daily

Intervention Type

Drug

Intervention Name(s)

enzalutamide

Other Intervention Name(s)

XTANDI

Intervention Description

160 mg (4 x 40 mg tablets) once daily

Primary Outcome Measure Information:

Title

Radiological Progression Free Survival (rPFS) by Blinded Independent Central Review (BICR) - Cohort A Only

Description

Time Frame

Tumor assessments every 8 weeks from randomisation until radiographic progression assessed by BICR (median duration of treatment of 7 and 4 months for Olaparib and Investigators Choice of NHA respectively).

Secondary Outcome Measure Information:

Title

Confirmed Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) - Cohort A Only

Description

Time Frame

Title

Radiological Progression Free Survival (rPFS) by Blinded Independent Central Review (BICR) - Cohort A+B

Description

Time Frame

Title

Time to Pain Progression - Cohort A Only

Description

Time Frame

Every 4 weeks from randomisation (for 7 consecutive days) throughout the study (median duration of treatment of 7 and 4 months for Olaparib and Investigators Choice of NHA respectively).

Title

Overall Survival (OS) - Cohort A Only

Description

Number of Participants with Overall Survival (OS) - Cohort A only.

Time Frame

Approximately 35 months after the first patient was randomised.

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

130 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria Histologically confirmed diagnosis of prostate cancer. Documented evidence of metastatic castration resistant prostate cancer (mCRPC). Subjects must have progressed on prior new hormonal agent (e.g. abiraterone acetate and/or enzalutamide) for the treatment of metastatic prostate cancer and/or CRPC . Ongoing therapy with LHRH analog or bilateral orchiectomy. Radiographic progression at study entry while on androgen deprivation therapy (or after bilateral orchiectomy). Qualifying HRR mutation in tumor tissue. Exclusion criteria Any previous treatment with PARP inhibitor, including olaparib. Subjects who have any previous treatment with DNA-damaging cytotoxic chemotherapy, except if for non-prostate cancer indication and last dose > 5 years prior to randomization. Other malignancy (including MDS and MGUS) within the last 5 years except: adequately treated non-melanoma skin cancer or other solid tumors curatively treated with no evidence of disease for ≥5 years. Subjects with known brain metastases.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Johann de Bono, M.D., Ph.D.

Organizational Affiliation

The Institute of Cancer Research, United Kingdom

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Maha Hussain, M.D., FACP, FASCO

Organizational Affiliation

Northwestern University, United States of America

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Site

City

Anchorage

State/Province

Alaska

ZIP/Postal Code

99503

Country

United States

Facility Name

Research Site

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85704

Country

United States

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Research Site

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85741

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United States

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Research Site

City

Duarte

State/Province

California

ZIP/Postal Code

91010

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United States

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Research Site

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San Diego

State/Province

California

ZIP/Postal Code

92161

Country

United States

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Research Site

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Santa Barbara

State/Province

California

ZIP/Postal Code

93105

Country

United States

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Research Site

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Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

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Research Site

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Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

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Research Site

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Atlanta

State/Province

Georgia

ZIP/Postal Code

30318

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United States

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Chicago

State/Province

Illinois

ZIP/Postal Code

60611

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United States

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Research Site

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Jeffersonville

State/Province

Indiana

ZIP/Postal Code

47130

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United States

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New Orleans

State/Province

Louisiana

ZIP/Postal Code

70112

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United States

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Baltimore

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Maryland

ZIP/Postal Code

21287

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United States

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Towson

State/Province

Maryland

ZIP/Postal Code

21204

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United States

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Research Site

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Omaha

State/Province

Nebraska

ZIP/Postal Code

68130

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United States

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Las Vegas

State/Province

Nevada

ZIP/Postal Code

89135

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United States

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Albany

State/Province

New York

ZIP/Postal Code

12208

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United States

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Bronx

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New York

ZIP/Postal Code

10468

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United States

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Brooklyn

State/Province

New York

ZIP/Postal Code

11201

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United States

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Syracuse

State/Province

New York

ZIP/Postal Code

13210

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United States

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Durham

State/Province

North Carolina

ZIP/Postal Code

27710

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United States

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Salisbury

State/Province

North Carolina

ZIP/Postal Code

28144

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United States

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Columbus

State/Province

Ohio

ZIP/Postal Code

43230

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United States

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Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

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United States

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Springfield

State/Province

Oregon

ZIP/Postal Code

97477

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United States

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Tualatin

State/Province

Oregon

ZIP/Postal Code

97062

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United States

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Charleston

State/Province

South Carolina

ZIP/Postal Code

29401

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United States

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Myrtle Beach

State/Province

South Carolina

ZIP/Postal Code

29572

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United States

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Germantown

State/Province

Tennessee

ZIP/Postal Code

38138

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United States

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Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

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United States

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San Antonio

State/Province

Texas

ZIP/Postal Code

78229

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United States

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Salt Lake City

State/Province

Utah

ZIP/Postal Code

84112

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United States

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Salt Lake City

State/Province

Utah

ZIP/Postal Code

84148

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United States

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Spokane

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Washington

ZIP/Postal Code

99202

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United States

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Wheeling

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West Virginia

ZIP/Postal Code

26003

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United States

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Buenos Aires

ZIP/Postal Code

1426

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Argentina

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Buenos Aires

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C1118AAT

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Argentina

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Buenos Aires

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C1120AAT

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Argentina

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Research Site

City

Caba

ZIP/Postal Code

C1280AEB

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Argentina

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Research Site

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La Rioja

ZIP/Postal Code

5300

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Argentina

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Rosario

ZIP/Postal Code

2000

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Argentina

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Adelaide

ZIP/Postal Code

5000

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Australia

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City

Box Hill

ZIP/Postal Code

3128

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Australia

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City

Clayton

ZIP/Postal Code

3168

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Australia

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City

Greenslopes

ZIP/Postal Code

4120

Country

Australia

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City

Herston

ZIP/Postal Code

4029

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Australia

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City

Macquarie University

ZIP/Postal Code

2109

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Australia

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Melbourne

ZIP/Postal Code

3000

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Australia

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City

Nedlands

ZIP/Postal Code

6009

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Australia

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Randwick

ZIP/Postal Code

2031

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Australia

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Waratah

ZIP/Postal Code

2298

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Australia

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Graz

ZIP/Postal Code

8036

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Austria

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Linz

ZIP/Postal Code

4020

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Austria

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Salzburg

ZIP/Postal Code

5020

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Austria

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Wien

ZIP/Postal Code

1020

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Austria

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City

Wien

ZIP/Postal Code

1090

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Austria

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City

Barretos

ZIP/Postal Code

14784-400

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Brazil

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City

Belo Horizonte

ZIP/Postal Code

30110-022

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Brazil

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City

Curitiba

ZIP/Postal Code

80530-010

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Brazil

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Florianópolis

ZIP/Postal Code

88034-000

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Brazil

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Passo Fundo

ZIP/Postal Code

99010-080

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Brazil

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Porto Alegre

ZIP/Postal Code

90160-093

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Brazil

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Porto Alegre

ZIP/Postal Code

90610-000

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Brazil

Facility Name

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Recife

ZIP/Postal Code

50040-000

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Brazil

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Research Site

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Ribeirao Preto

ZIP/Postal Code

14015-140

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Brazil

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Rio de Janeiro

ZIP/Postal Code

22793-080

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Brazil

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Santo Andre

ZIP/Postal Code

09060-650

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Brazil

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São José do Rio Preto

ZIP/Postal Code

15090-000

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Brazil

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São Paulo

ZIP/Postal Code

01321-001

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Brazil

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São Paulo

ZIP/Postal Code

03102-002

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Brazil

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City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1Z2

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Canada

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City

Kelowna

State/Province

British Columbia

ZIP/Postal Code

V1Y 5L3

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Canada

Facility Name

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City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 4E6

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Canada

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City

Hamilton

State/Province

Ontario

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L8V 5C2

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Canada

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City

Oakville

State/Province

Ontario

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L6H 3P1

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Canada

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City

Toronto

State/Province

Ontario

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M4N 3M5

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Canada

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City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

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Canada

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City

Chicoutimi

State/Province

Quebec

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G7H 5H6

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Canada

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City

Montreal

State/Province

Quebec

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H2X 3E4

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Canada

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City

Montreal

State/Province

Quebec

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H4A 3J1

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Canada

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City

Saskatoon

State/Province

Saskatchewan

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S7N 4H4

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Canada

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City

Quebec

ZIP/Postal Code

G1J 1Z4

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Canada

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City

Odense C

ZIP/Postal Code

5000

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Denmark

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City

BESANCON Cedex

ZIP/Postal Code

25030

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France

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City

Bordeaux Cedex

ZIP/Postal Code

33000

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France

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City

Caen

ZIP/Postal Code

14000

Country

France

Facility Name

Research Site

City

Lille

ZIP/Postal Code

59020

Country

France

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Research Site

City

Lyon Cedex 08

ZIP/Postal Code

69008

Country

France

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Research Site

City

Marseille cedex 09

ZIP/Postal Code

13273

Country

France

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Research Site

City

Montpellier

ZIP/Postal Code

34298

Country

France

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City

Paris

ZIP/Postal Code

75014

Country

France

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City

Poitiers Cedex

ZIP/Postal Code

86021

Country

France

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City

Saint Herblain

ZIP/Postal Code

44805

Country

France

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City

Toulouse Cedex 09

ZIP/Postal Code

31100

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France

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City

Vandoeuvre les Nancy

ZIP/Postal Code

54519

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France

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City

Villejuif

ZIP/Postal Code

94805

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France

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Bergisch Gladbach

ZIP/Postal Code

51465

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Germany

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Berlin

ZIP/Postal Code

13055

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Germany

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Bremen

ZIP/Postal Code

28277

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Germany

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Duisburg

ZIP/Postal Code

47179

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Germany

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Research Site

City

Düsseldorf

ZIP/Postal Code

40225

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Germany

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Research Site

City

Hamburg

ZIP/Postal Code

22399

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Germany

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Research Site

City

Heidelberg

ZIP/Postal Code

69120

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Germany

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Research Site

City

Holzminden

ZIP/Postal Code

37603

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Germany

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Research Site

City

Jena

ZIP/Postal Code

07747

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Germany

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Research Site

City

Köln

ZIP/Postal Code

50968

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Germany

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Research Site

City

Magdeburg

ZIP/Postal Code

39120

Country

Germany

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Research Site

City

Nürnberg

ZIP/Postal Code

90491

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Germany

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Research Site

City

Nürtingen

ZIP/Postal Code

72622

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Germany

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City

Tübingen

ZIP/Postal Code

72076

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Germany

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Research Site

City

Wuppertal

ZIP/Postal Code

42109

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Germany

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Research Site

City

Haifa

ZIP/Postal Code

31096

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Israel

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Research Site

City

Jerusalem

ZIP/Postal Code

91120

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Israel

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Research Site

City

Kfar Saba

ZIP/Postal Code

95847

Country

Israel

Facility Name

Research Site

City

Petach-Tikva

ZIP/Postal Code

4941492

Country

Israel

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Research Site

City

Ramat Gan

ZIP/Postal Code

5265601

Country

Israel

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Research Site

City

Zerifin

ZIP/Postal Code

70300

Country

Israel

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Research Site

City

Ancona

ZIP/Postal Code

60126

Country

Italy

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Research Site

City

Arezzo

ZIP/Postal Code

52100

Country

Italy

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Research Site

City

Bari

ZIP/Postal Code

70124

Country

Italy

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Research Site

City

Brescia

ZIP/Postal Code

25100

Country

Italy

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Research Site

City

Meldola

ZIP/Postal Code

47014

Country

Italy

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Research Site

City

Milano

ZIP/Postal Code

20133

Country

Italy

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Research Site

City

Milano

ZIP/Postal Code

20141

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Italy

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Research Site

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Modena

ZIP/Postal Code

41124

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Italy

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Research Site

City

Napoli

ZIP/Postal Code

80131

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Italy

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Research Site

City

Trento

ZIP/Postal Code

38100

Country

Italy

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Research Site

City

Bunkyo-ku

ZIP/Postal Code

113-8431

Country

Japan

Facility Name

Research Site

City

Bunkyo-ku

ZIP/Postal Code

113-8510

Country

Japan

Facility Name

Research Site

City

Bunkyo-ku

ZIP/Postal Code

113-8603

Country

Japan

Facility Name

Research Site

City

Fukuoka

ZIP/Postal Code

812-8582

Country

Japan

Facility Name

Research Site

City

Hirosaki-shi

ZIP/Postal Code

036-8563

Country

Japan

Facility Name

Research Site

City

Kanazawa-shi

ZIP/Postal Code

920-8641

Country

Japan

Facility Name

Research Site

City

Kashihara-shi

ZIP/Postal Code

634-8522

Country

Japan

Facility Name

Research Site

City

Kashiwa

ZIP/Postal Code

277-8577

Country

Japan

Facility Name

Research Site

City

Kawagoe-shi

ZIP/Postal Code

350-8550

Country

Japan

Facility Name

Research Site

City

Kita-gun

ZIP/Postal Code

761-0793

Country

Japan

Facility Name

Research Site

City

Koto-ku

ZIP/Postal Code

135-8550

Country

Japan

Facility Name

Research Site

City

Kyoto-shi

ZIP/Postal Code

606-8507

Country

Japan

Facility Name

Research Site

City

Maebashi-shi

ZIP/Postal Code

371-8811

Country

Japan

Facility Name

Research Site

City

Matsuyama-shi

ZIP/Postal Code

791-0280

Country

Japan

Facility Name

Research Site

City

Minato-ku

ZIP/Postal Code

105-8471

Country

Japan

Facility Name

Research Site

City

Mitaka-shi

ZIP/Postal Code

181-8611

Country

Japan

Facility Name

Research Site

City

Miyazaki-shi

ZIP/Postal Code

889-1692

Country

Japan

Facility Name

Research Site

City

Nagasaki-shi

ZIP/Postal Code

852-8501

Country

Japan

Facility Name

Research Site

City

Nagoya-shi

ZIP/Postal Code

464-8681

Country

Japan

Facility Name

Research Site

City

Nagoya-shi

ZIP/Postal Code

466-8560

Country

Japan

Facility Name

Research Site

City

Osaka-shi

ZIP/Postal Code

541-8567

Country

Japan

Facility Name

Research Site

City

Osaka-shi

ZIP/Postal Code

545-8586

Country

Japan

Facility Name

Research Site

City

Osakasayama-shi

ZIP/Postal Code

589-8511

Country

Japan

Facility Name

Research Site

City

Sagamihara-shi

ZIP/Postal Code

252-0375

Country

Japan

Facility Name

Research Site

City

Sakura-shi

ZIP/Postal Code

285-8741

Country

Japan

Facility Name

Research Site

City

Sapporo-shi

ZIP/Postal Code

060-8648

Country

Japan

Facility Name

Research Site

City

Shinjuku-ku

ZIP/Postal Code

160-8582

Country

Japan

Facility Name

Research Site

City

Suita-shi

ZIP/Postal Code

565-0871

Country

Japan

Facility Name

Research Site

City

Sunto-gun

ZIP/Postal Code

411-8777

Country

Japan

Facility Name

Research Site

City

Yokohama-shi

ZIP/Postal Code

232-0024

Country

Japan

Facility Name

Research Site

City

Busan

ZIP/Postal Code

49241

Country

Korea, Republic of

Facility Name

Research Site

City

Daegu

ZIP/Postal Code

41404

Country

Korea, Republic of

Facility Name

Research Site

City

Goyang-si

ZIP/Postal Code

10408

Country

Korea, Republic of

Facility Name

Research Site

City

Gwangju

ZIP/Postal Code

61469

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

06273

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

06591

Country

Korea, Republic of

Facility Name

Research Site

City

Amsterdam

ZIP/Postal Code

1066 CX

Country

Netherlands

Facility Name

Research Site

City

Hilversum

ZIP/Postal Code

1213 XZ

Country

Netherlands

Facility Name

Research Site

City

Leiden

ZIP/Postal Code

2333 ZA

Country

Netherlands

Facility Name

Research Site

City

Nijmegen

ZIP/Postal Code

6525 GA

Country

Netherlands

Facility Name

Research Site

City

Tilburg

ZIP/Postal Code

5042 AD

Country

Netherlands

Facility Name

Research Site

City

Zwolle

ZIP/Postal Code

8025 AB

Country

Netherlands

Facility Name

Research Site

City

Lørenskog

ZIP/Postal Code

N-1478

Country

Norway

Facility Name

Research Site

City

Gerona

ZIP/Postal Code

17007

Country

Spain

Facility Name

Research Site

City

Madrid

ZIP/Postal Code

08035

Country

Spain

Facility Name

Research Site

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Research Site

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Research Site

City

Malaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

Research Site

City

Oviedo

ZIP/Postal Code

33011

Country

Spain

Facility Name

Research Site

City

Sevilla

ZIP/Postal Code

41009

Country

Spain

Facility Name

Research Site

City

Göteborg

ZIP/Postal Code

413 45

Country

Sweden

Facility Name

Research Site

City

Solna

ZIP/Postal Code

171 64

Country

Sweden

Facility Name

Research Site

City

Changhua City

ZIP/Postal Code

50006

Country

Taiwan

Facility Name

Research Site

City

Kaohsiung

ZIP/Postal Code

807

Country

Taiwan

Facility Name

Research Site

City

Kaohsiung

ZIP/Postal Code

833

Country

Taiwan

Facility Name

Research Site

City

Taichung

ZIP/Postal Code

404

Country

Taiwan

Facility Name

Research Site

City

Taichung

ZIP/Postal Code

40705

Country

Taiwan

Facility Name

Research Site

City

Tainan

ZIP/Postal Code

70403

Country

Taiwan

Facility Name

Research Site

City

Taipei

ZIP/Postal Code

10002

Country

Taiwan

Facility Name

Research Site

City

Taipei

ZIP/Postal Code

112

Country

Taiwan

Facility Name

Research Site

City

Taoyuan City

ZIP/Postal Code

333

Country

Taiwan

Facility Name

Research Site

City

Adana

ZIP/Postal Code

01120

Country

Turkey

Facility Name

Research Site

City

Ankara

ZIP/Postal Code

06230

Country

Turkey

Facility Name

Research Site

City

Ankara

ZIP/Postal Code

06340

Country

Turkey

Facility Name

Research Site

City

Ankara

ZIP/Postal Code

06590

Country

Turkey

Facility Name

Research Site

City

Edirne

ZIP/Postal Code

22030

Country

Turkey

Facility Name

Research Site

City

Istanbul

ZIP/Postal Code

34030

Country

Turkey

Facility Name

Research Site

City

Istanbul

ZIP/Postal Code

34365

Country

Turkey

Facility Name

Research Site

City

Karsiyaka

ZIP/Postal Code

35575

Country

Turkey

Facility Name

Research Site

City

London

ZIP/Postal Code

EC1M 6BQ

Country

United Kingdom

Facility Name

Research Site

City

London

ZIP/Postal Code

NW1 2PG

Country

United Kingdom

Facility Name

Research Site

City

Manchester

ZIP/Postal Code

M20 4BX

Country

United Kingdom

Facility Name

Research Site

City

Romford

ZIP/Postal Code

RM7 0BE

Country

United Kingdom

Facility Name

Research Site

City

Sutton

ZIP/Postal Code

SM25PT

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

35598359

Citation

Roubaud G, Ozguroglu M, Penel N, Matsubara N, Mehra N, Kolinsky MP, Procopio G, Feyerabend S, Joung JY, Gravis G, Nishimura K, Gedye C, Padua C, Shore N, Thiery-Vuillemin A, Saad F, van Alphen R, Carducci MA, Desai C, Brickel N, Poehlein C, Del Rosario P, Fizazi K. Olaparib tolerability and common adverse-event management in patients with metastatic castration-resistant prostate cancer: Further analyses from the PROfound study. Eur J Cancer. 2022 Jul;170:73-84. doi: 10.1016/j.ejca.2022.04.016. Epub 2022 May 19.

Results Reference

derived

PubMed Identifier

35229141

Citation

Matsubara N, Nishimura K, Kawakami S, Joung JY, Uemura H, Goto T, Kwon TG, Sugimoto M, Kato M, Wang SS, Pang ST, Chen CH, Fujita T, Nii M, Shen L, Dujka M, Hussain M, de Bono J. Olaparib in patients with mCRPC with homologous recombination repair gene alterations: PROfound Asian subset analysis. Jpn J Clin Oncol. 2022 May 5;52(5):441-448. doi: 10.1093/jjco/hyac015.

Results Reference

derived

PubMed Identifier

35157830

Citation

Thiery-Vuillemin A, de Bono J, Hussain M, Roubaud G, Procopio G, Shore N, Fizazi K, Dos Anjos G, Gravis G, Joung JY, Matsubara N, Castellano D, Degboe A, Gresty C, Kang J, Allen A, Poehlein C, Saad F. Pain and health-related quality of life with olaparib versus physician's choice of next-generation hormonal drug in patients with metastatic castration-resistant prostate cancer with homologous recombination repair gene alterations (PROfound): an open-label, randomised, phase 3 trial. Lancet Oncol. 2022 Mar;23(3):393-405. doi: 10.1016/S1470-2045(22)00017-1. Epub 2022 Feb 11. Erratum In: Lancet Oncol. 2022 Apr;23(4):e161.

Results Reference

derived

PubMed Identifier

35091440

Citation

Hussain M, Corcoran C, Sibilla C, Fizazi K, Saad F, Shore N, Sandhu S, Mateo J, Olmos D, Mehra N, Kolinsky MP, Roubaud G, Ozguroglu M, Matsubara N, Gedye C, Choi YD, Padua C, Kohlmann A, Huisden R, Elvin JA, Kang J, Adelman CA, Allen A, Poehlein C, de Bono J. Tumor Genomic Testing for >4,000 Men with Metastatic Castration-resistant Prostate Cancer in the Phase III Trial PROfound (Olaparib). Clin Cancer Res. 2022 Apr 14;28(8):1518-1530. doi: 10.1158/1078-0432.CCR-21-3940.

Results Reference

derived

PubMed Identifier

32955174

Citation

Hussain M, Mateo J, Fizazi K, Saad F, Shore N, Sandhu S, Chi KN, Sartor O, Agarwal N, Olmos D, Thiery-Vuillemin A, Twardowski P, Roubaud G, Ozguroglu M, Kang J, Burgents J, Gresty C, Corcoran C, Adelman CA, de Bono J; PROfound Trial Investigators. Survival with Olaparib in Metastatic Castration-Resistant Prostate Cancer. N Engl J Med. 2020 Dec 10;383(24):2345-2357. doi: 10.1056/NEJMoa2022485. Epub 2020 Sep 20.

Results Reference

derived

PubMed Identifier

32343890

Citation

de Bono J, Mateo J, Fizazi K, Saad F, Shore N, Sandhu S, Chi KN, Sartor O, Agarwal N, Olmos D, Thiery-Vuillemin A, Twardowski P, Mehra N, Goessl C, Kang J, Burgents J, Wu W, Kohlmann A, Adelman CA, Hussain M. Olaparib for Metastatic Castration-Resistant Prostate Cancer. N Engl J Med. 2020 May 28;382(22):2091-2102. doi: 10.1056/NEJMoa1911440. Epub 2020 Apr 28.

Results Reference

derived

Links:

URL

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D081DC00007&attachmentIdentifier=fe1712ee-5e58-4f7d-a072-3044f698908d&fileName=D081DC00007_CSP_redacted.pdf&versionIdentifier=

Description

CSP redacted

URL

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D081DC00007&attachmentIdentifier=441f6e9d-6f12-410a-9352-dca653de8d9c&fileName=D081DC00007_SAP_redacted.pdf&versionIdentifier=

Description

redacted SAP

URL

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D081DC00007&attachmentIdentifier=cedcfc75-9a55-4974-b756-654ad809ea1b&fileName=d081dc00007-addendum-2-study-synopsis_Redacted.pdf&versionIdentifier=

Description

Redacted CSR synopsis

Learn more about this trial

Study of Olaparib (Lynparza™) Versus Enzalutamide or Abiraterone Acetate in Men With Metastatic Castration-Resistant Prostate Cancer (PROfound Study)

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Study of Olaparib (Lynparza™) Versus Enzalutamide or Abiraterone Acetate in Men With Metastatic Castration-Resistant Prostate Cancer (PROfound Study)

Metastatic Castration-resistant Prostate Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial