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EMD 525797 in Subjects With Asymptomatic or Mildly Symptomatic Metastatic Castrate-resistant Prostate Cancer (PERSEUS)

Primary Purpose

Prostate Cancer Metastatic

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
EMD 525797
EMD 525797
Placebo
Standard of Care (SoC)
Sponsored by
EMD Serono
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer Metastatic focused on measuring Asymptomatic, mildly symptomatic, metastatic castrate-resistant prostate cancer, mCRPC

Eligibility Criteria

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

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate (Gleason score)
  • Bisphosphonate treatment
  • Stable, ongoing adequate testosterone suppression proven by hypogonadal levels of testosterone (less than or equal to) <= 50 nanogram per deciliter [ng/dL]) for subjects without surgical castration (luteinizing hormone-releasing hormone antagonists and agonists)
  • Other protocol defined inclusion criteria could apply

Exclusion Criteria:

  • Prior chemotherapy, biologic therapy (targeted therapy), or any experimental therapy for mCRPC
  • Chronic and ongoing treatment with opioids
  • Acute pathologic fracture, spinal cord compression, or hypercalcemia at Screening
  • Visceral metastasis, brain metastasis
  • Radiotherapy to bone lesions and/or orthopedic surgery for pathologic fractures. Any kinds of major elective surgery within 30 days prior to trial treatment
  • Other protocol defined exclusion criteria could apply

Sites / Locations

  • Research Site
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  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • ZNA Middelheim Oncologie
  • Brandord Urology Research
  • Exdeo Clinical Research Inc.
  • Can-Med Clinical Research Inc.
  • Sunnybrook Health Sciences Centre
  • Research Site
  • Research Site
  • Research Site
  • Center Alexis Vaurrin
  • Research Site
  • Hôpitaux Civils de Colmar-CH Louis Pasteur
  • Research Site
  • Research Site
  • Institute Gustave Roussy
  • Research Site
  • Universitätsmedizin Charité, Campus Benjamin Franklin, Urologische Klinik and Poliklinik
  • Research Site
  • Universitätsklinikum Carl Gustav Carus an der Techischen Universität Dresden, Klinik und Poliklinik für Urologie
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Studienpraxis Urologie
  • Universitätsklinikum Tübinger, Klinik und Poliklinik für Urologie
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Altay Regional Oncology Dispensary
  • Research Site
  • Research Site
  • State Institution of Healthcare Ivanovo Regional Oncology Dispensary
  • Budzhet Clinical Oncology Center
  • Research Site
  • Krasnoyarsk State Medical University Oncology and Radiotherapy Territorial Dispensary
  • Research Site
  • City Hospital # 2
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo + Standard of care (SoC)

EMD 525797 750 mg + SoC

EMD 525797 1500 mg + SoC

Arm Description

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS) Time
PFS was defined as time from randomization until the first documented sign of objective radiographic disease progression (ORDP) or death from any cause. Death was considered as an event only if it was reported within 12 weeks after last tumor assessment without progression. ORDP was defined as: Bone lesion progression (2 or more new bone lesions compared to baseline) assessed with bone scintigraphy. Assessment was based on Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) modified as per Prostate Cancer Working Group 2 (PCWG-2); Soft-tissue lesion progression assessed with CT scans according to RECIST v1.0 modified as per PCWG-2; Presence of skeletal events defined as cord compression/fracture documented via a scheduled or unscheduled radiographic assessment triggered by increased pain or other signs and/or symptoms, based on the investigator's discretion; Non-radiological events, including emergency bone irradiation and surgery, were not investigated.

Secondary Outcome Measures

Overall Survival
Overall Survival was defined as the time from the date of randomization to the date of death from any cause.
Time to Tumor Progression
Time to tumor progression was defined as the time from the date of randomization to the date of ORDP. ORDP was defined as: Bone lesion progression (2 or more new bone lesions compared to baseline) assessed with bone scintigraphy, which had to be confirmed by bone scintigraphy 6 weeks later if subjects remained asymptomatic or mildly symptomatic. Assessments were to be based on RECIST v1.0 modified according to PCWG-2; Soft-tissue lesion progression assessed with CT scans according to RECIST v1.0 modified as per PCWG-2; Presence of skeletal events defined as cord compression or fracture documented via a scheduled or unscheduled radiographic assessment triggered by increased pain or other signs and/or symptoms, based on the investigator's discretion; Non-radiological events, including emergency bone irradiation and surgery, were not investigated.
Number of Subjects With Presence of Tumor Response and Disease Control (DC) in Soft Tissue Lesions
Presence of tumor response in soft tissue lesions was defined as the presence of at least 1 confirmed complete response (CR) or confirmed partial response (PR) in soft tissue lesions, documented by computed tomography (CT) scans. Presence of DC in soft tissue lesions was defined as the presence of at least 1 confirmed CR or confirmed PR or stable disease (SD) lasting at least 12 weeks after randomization. Tumor response assessments were based on RECIST v1.0 modified according to the PCWG-2. The response was evaluated for subjects with measurable disease at baseline. According to RECIST v1.0, CR=disappearance of all target and non-target lesions; PR=at least 30% decrease in the sum of the longest diameter of target lesions and non-complete response/non-progressive disease in non-target lesions.
Number of Subjects With New Bone Lesions Compared to Baseline
New bone lesions were evaluated by bone scintigraphy for subjects with bone lesions at baseline.
Number of Subjects With Presence of DC in Bone Lesions
Presence of DC in bone lesions was defined as the appearance of less than 2 new bone lesions, documented by bone scintigraphy.
Bone and Soft Tissue Lesions Composite Tumor Response
Bone and soft tissue lesions composite tumor response was defined as the presence of both a confirmed CR or PR, documented by CT scans, and a DC in bone lesions, documented by bone scintigraphy. CR was defined as disappearance of all target and non-target lesions and PR was defined as at least 30% decrease in the sum of the longest diameter of target lesions and non-complete response/non-progressive disease in non-target lesions. Presence of DC in bone lesions was defined as the appearance of less than 2 new bone lesions.
Number of Subjects With Presence of Skeletal Related Events
Presence of skeletal related events was defined as cord compression or fracture documented via a scheduled or unscheduled radiographic assessment triggered by increased pain or other signs and/or symptoms at the investigator discretion. Non-radiological events, including emergency bone irradiation and surgery, were not investigated.
Number of Subjects With Presence of Prostate Specific Antigen (PSA) Response
PSA response was defined as a decrease greater than 50 percent (%) in PSA value from baseline for 2 consecutive evaluations greater than or equal to (>=) 3 Weeks apart.
Minimum Percentage Change From Baseline in PSA Serum Concentration
Minimum Percentage Change From Baseline in the Number of Circulating Tumor Cells (CTCs)
Overall Minimum Percentage Change From Previous Time Point in Circulating Tumor Cells (CTC)
Number of Subjects With Any Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death, and TEAEs Leading to Discontinuation
An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A serious adverse event was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs were defined as those AEs that started between first dose of study drug and up to 50 days after last dose.
Pharmacokinetic Parameter: Clearance of Intravenously Administered EMD 525797 After First Dose (CL) and Clearance in Steady State of EMD52597 After Fifth Dose (CLss)
The apparent total body clearance of drug following intravenous administration (CL); The apparent total body clearance of drug at steady state following intravenous administration (CLss).
Pharmacokinetic Parameter: Volume of Distribution of EMD 525797 After the First Dose (V) and in Steady State After the Fifth Dose (Vss) of Intravenous Infusion
The apparent volume of distribution during the terminal phase following intravenous administration (V). The estimate of the apparent volume of distribution at steady state following intravenous administration (Vss).

Full Information

First Posted
April 15, 2011
Last Updated
November 9, 2015
Sponsor
EMD Serono
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1. Study Identification

Unique Protocol Identification Number
NCT01360840
Brief Title
EMD 525797 in Subjects With Asymptomatic or Mildly Symptomatic Metastatic Castrate-resistant Prostate Cancer
Acronym
PERSEUS
Official Title
A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Trial Investigating Two Doses of EMD 525797 in Subjects With Asymptomatic or Mildly Symptomatic Metastatic Castrate-resistant Prostate Cancer (mCRPC)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMD Serono

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of the trial is to evaluate the clinical anti-tumor activity of EMD 525797 administered as 1-hour intravenous infusion every 3 weeks in terms of progression free survival (PFS) time in subjects with asymptomatic or mildly symptomatic metastatic castrate-resistant prostate cancer (mCRPC).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer Metastatic
Keywords
Asymptomatic, mildly symptomatic, metastatic castrate-resistant prostate cancer, mCRPC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo + Standard of care (SoC)
Arm Type
Placebo Comparator
Arm Title
EMD 525797 750 mg + SoC
Arm Type
Experimental
Arm Title
EMD 525797 1500 mg + SoC
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
EMD 525797
Intervention Description
Subjects will be administered with EMD 525797 at a dose of 1500 milligram (mg) (diluted with 0.9 percent [%] sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons.
Intervention Type
Drug
Intervention Name(s)
EMD 525797
Intervention Description
Subjects will be administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Subjects will be administered with placebo (as 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons.
Intervention Type
Other
Intervention Name(s)
Standard of Care (SoC)
Intervention Description
All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists).
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS) Time
Description
PFS was defined as time from randomization until the first documented sign of objective radiographic disease progression (ORDP) or death from any cause. Death was considered as an event only if it was reported within 12 weeks after last tumor assessment without progression. ORDP was defined as: Bone lesion progression (2 or more new bone lesions compared to baseline) assessed with bone scintigraphy. Assessment was based on Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) modified as per Prostate Cancer Working Group 2 (PCWG-2); Soft-tissue lesion progression assessed with CT scans according to RECIST v1.0 modified as per PCWG-2; Presence of skeletal events defined as cord compression/fracture documented via a scheduled or unscheduled radiographic assessment triggered by increased pain or other signs and/or symptoms, based on the investigator's discretion; Non-radiological events, including emergency bone irradiation and surgery, were not investigated.
Time Frame
Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Overall Survival was defined as the time from the date of randomization to the date of death from any cause.
Time Frame
Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Title
Time to Tumor Progression
Description
Time to tumor progression was defined as the time from the date of randomization to the date of ORDP. ORDP was defined as: Bone lesion progression (2 or more new bone lesions compared to baseline) assessed with bone scintigraphy, which had to be confirmed by bone scintigraphy 6 weeks later if subjects remained asymptomatic or mildly symptomatic. Assessments were to be based on RECIST v1.0 modified according to PCWG-2; Soft-tissue lesion progression assessed with CT scans according to RECIST v1.0 modified as per PCWG-2; Presence of skeletal events defined as cord compression or fracture documented via a scheduled or unscheduled radiographic assessment triggered by increased pain or other signs and/or symptoms, based on the investigator's discretion; Non-radiological events, including emergency bone irradiation and surgery, were not investigated.
Time Frame
Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Title
Number of Subjects With Presence of Tumor Response and Disease Control (DC) in Soft Tissue Lesions
Description
Presence of tumor response in soft tissue lesions was defined as the presence of at least 1 confirmed complete response (CR) or confirmed partial response (PR) in soft tissue lesions, documented by computed tomography (CT) scans. Presence of DC in soft tissue lesions was defined as the presence of at least 1 confirmed CR or confirmed PR or stable disease (SD) lasting at least 12 weeks after randomization. Tumor response assessments were based on RECIST v1.0 modified according to the PCWG-2. The response was evaluated for subjects with measurable disease at baseline. According to RECIST v1.0, CR=disappearance of all target and non-target lesions; PR=at least 30% decrease in the sum of the longest diameter of target lesions and non-complete response/non-progressive disease in non-target lesions.
Time Frame
Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Title
Number of Subjects With New Bone Lesions Compared to Baseline
Description
New bone lesions were evaluated by bone scintigraphy for subjects with bone lesions at baseline.
Time Frame
Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Title
Number of Subjects With Presence of DC in Bone Lesions
Description
Presence of DC in bone lesions was defined as the appearance of less than 2 new bone lesions, documented by bone scintigraphy.
Time Frame
At Weeks 13, 19 and 25
Title
Bone and Soft Tissue Lesions Composite Tumor Response
Description
Bone and soft tissue lesions composite tumor response was defined as the presence of both a confirmed CR or PR, documented by CT scans, and a DC in bone lesions, documented by bone scintigraphy. CR was defined as disappearance of all target and non-target lesions and PR was defined as at least 30% decrease in the sum of the longest diameter of target lesions and non-complete response/non-progressive disease in non-target lesions. Presence of DC in bone lesions was defined as the appearance of less than 2 new bone lesions.
Time Frame
Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Title
Number of Subjects With Presence of Skeletal Related Events
Description
Presence of skeletal related events was defined as cord compression or fracture documented via a scheduled or unscheduled radiographic assessment triggered by increased pain or other signs and/or symptoms at the investigator discretion. Non-radiological events, including emergency bone irradiation and surgery, were not investigated.
Time Frame
Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Title
Number of Subjects With Presence of Prostate Specific Antigen (PSA) Response
Description
PSA response was defined as a decrease greater than 50 percent (%) in PSA value from baseline for 2 consecutive evaluations greater than or equal to (>=) 3 Weeks apart.
Time Frame
Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Title
Minimum Percentage Change From Baseline in PSA Serum Concentration
Time Frame
Baseline, up to data cut-off date (30 April 2013), assessed up to 2 years
Title
Minimum Percentage Change From Baseline in the Number of Circulating Tumor Cells (CTCs)
Time Frame
Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years
Title
Overall Minimum Percentage Change From Previous Time Point in Circulating Tumor Cells (CTC)
Time Frame
Cycle 1, Day 1 (Week 1): pre-dose, Cycle 3, Day 1 (Week 7): pre-dose, and Cycle 5, Day 1 (Week 13): pre-dose
Title
Number of Subjects With Any Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death, and TEAEs Leading to Discontinuation
Description
An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A serious adverse event was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs were defined as those AEs that started between first dose of study drug and up to 50 days after last dose.
Time Frame
From the first dose of study drug administration until 50 days after the last dose of study drug administration or until cut-off date (30 April 2013), assessed up to 2 years
Title
Pharmacokinetic Parameter: Clearance of Intravenously Administered EMD 525797 After First Dose (CL) and Clearance in Steady State of EMD52597 After Fifth Dose (CLss)
Description
The apparent total body clearance of drug following intravenous administration (CL); The apparent total body clearance of drug at steady state following intravenous administration (CLss).
Time Frame
Cycle 1 (Week 1) and cycle 5 (Week 13): Day 1: pre-dose, End of Infusion (EOI), 4, 8, 24, 48, 96, 168, 336, and 504 hours after start of infusion; Cycles 3 and 4 (Weeks 7 and 10), Day 1: pre-dose; Cycle 7 (Week 19), Day 1: pre-dose and EOI
Title
Pharmacokinetic Parameter: Volume of Distribution of EMD 525797 After the First Dose (V) and in Steady State After the Fifth Dose (Vss) of Intravenous Infusion
Description
The apparent volume of distribution during the terminal phase following intravenous administration (V). The estimate of the apparent volume of distribution at steady state following intravenous administration (Vss).
Time Frame
Cycle 1 (Week 1) and cycle 5 (Week 13): Day 1: pre-dose, End of Infusion (EOI), 4, 8, 24, 48, 96, 168, 336, and 504 hours after start of infusion; Cycles 3 and 4 (Weeks 7 and 10), Day 1: pre-dose; Cycle 7 (Week 19), Day 1: pre-dose and EOI
Other Pre-specified Outcome Measures:
Title
To Explore the Relationship Between Number and/or Changes of Numbers of Biomarker and the Clinical Outcome
Time Frame
From the date of randomization up to data cut-off date (30 April 2013), assessed up to 2 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed adenocarcinoma of the prostate (Gleason score) Bisphosphonate treatment Stable, ongoing adequate testosterone suppression proven by hypogonadal levels of testosterone (less than or equal to) <= 50 nanogram per deciliter [ng/dL]) for subjects without surgical castration (luteinizing hormone-releasing hormone antagonists and agonists) Other protocol defined inclusion criteria could apply Exclusion Criteria: Prior chemotherapy, biologic therapy (targeted therapy), or any experimental therapy for mCRPC Chronic and ongoing treatment with opioids Acute pathologic fracture, spinal cord compression, or hypercalcemia at Screening Visceral metastasis, brain metastasis Radiotherapy to bone lesions and/or orthopedic surgery for pathologic fractures. Any kinds of major elective surgery within 30 days prior to trial treatment Other protocol defined exclusion criteria could apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Responsible
Organizational Affiliation
EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Pleasant Hill
State/Province
California
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
Research Site
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
Research Site
City
New Brunswick
State/Province
New Jersey
Country
United States
Facility Name
Research Site
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Tyler
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Roanoke
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Spokane
State/Province
Washington
Country
United States
Facility Name
Research Site
City
Bendigo
Country
Australia
Facility Name
Research Site
City
Coffs Harbour
Country
Australia
Facility Name
Research Site
City
Darlinghurst
Country
Australia
Facility Name
Research Site
City
Frankston
Country
Australia
Facility Name
Research Site
City
Gosford
Country
Australia
Facility Name
Research Site
City
Kurralta Park
Country
Australia
Facility Name
Research Site
City
Northmead
Country
Australia
Facility Name
Research Site
City
Port Macquarie
Country
Australia
Facility Name
Research Site
City
Randwick
Country
Australia
Facility Name
Research Site
City
Turnhout
Country
Australia
Facility Name
ZNA Middelheim Oncologie
City
Antwerp
Country
Belgium
Facility Name
Brandord Urology Research
City
Brantford
State/Province
Ontario
Country
Canada
Facility Name
Exdeo Clinical Research Inc.
City
Abbotsford
Country
Canada
Facility Name
Can-Med Clinical Research Inc.
City
Province of British Columbia
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
Country
Canada
Facility Name
Research Site
City
Victoria
Country
Canada
Facility Name
Research Site
City
Windsor
Country
Canada
Facility Name
Research Site
City
Angers
Country
France
Facility Name
Center Alexis Vaurrin
City
Bourgogne
Country
France
Facility Name
Research Site
City
Caen Cedex 05
Country
France
Facility Name
Hôpitaux Civils de Colmar-CH Louis Pasteur
City
Colmar
Country
France
Facility Name
Research Site
City
Paris
Country
France
Facility Name
Research Site
City
Reims
Country
France
Facility Name
Institute Gustave Roussy
City
Villejuif
Country
France
Facility Name
Research Site
City
Aachen
Country
Germany
Facility Name
Universitätsmedizin Charité, Campus Benjamin Franklin, Urologische Klinik and Poliklinik
City
Berlin
Country
Germany
Facility Name
Research Site
City
Darmstadt
Country
Germany
Facility Name
Universitätsklinikum Carl Gustav Carus an der Techischen Universität Dresden, Klinik und Poliklinik für Urologie
City
Dresden
Country
Germany
Facility Name
Research Site
City
Esslingen
Country
Germany
Facility Name
Research Site
City
Freiburg
Country
Germany
Facility Name
Research Site
City
Hannover
Country
Germany
Facility Name
Research Site
City
Nürtingen
Country
Germany
Facility Name
Studienpraxis Urologie
City
Reutlingen
Country
Germany
Facility Name
Universitätsklinikum Tübinger, Klinik und Poliklinik für Urologie
City
Tübingen
Country
Germany
Facility Name
Research Site
City
Blaricum
Country
Netherlands
Facility Name
Research Site
City
Groningen
Country
Netherlands
Facility Name
Research Site
City
Haarlem
Country
Netherlands
Facility Name
Research Site
City
Gdańsk
Country
Poland
Facility Name
Research Site
City
Lublin
Country
Poland
Facility Name
Research Site
City
Łódź
Country
Poland
Facility Name
Altay Regional Oncology Dispensary
City
Barnaul
Country
Russian Federation
Facility Name
Research Site
City
Barnaul
Country
Russian Federation
Facility Name
Research Site
City
Ekaterinburg
Country
Russian Federation
Facility Name
State Institution of Healthcare Ivanovo Regional Oncology Dispensary
City
Ivanovo
Country
Russian Federation
Facility Name
Budzhet Clinical Oncology Center
City
Izhevsk
Country
Russian Federation
Facility Name
Research Site
City
Kazan
Country
Russian Federation
Facility Name
Krasnoyarsk State Medical University Oncology and Radiotherapy Territorial Dispensary
City
Krasnoyarsk
Country
Russian Federation
Facility Name
Research Site
City
Omsk
Country
Russian Federation
Facility Name
City Hospital # 2
City
Petersburg
Country
Russian Federation
Facility Name
Research Site
City
Stavropol
Country
Russian Federation
Facility Name
Research Site
City
Presov
Country
Slovakia
Facility Name
Research Site
City
Gauteng
Country
South Africa
Facility Name
Research Site
City
Kwa-Zulu Natal
Country
South Africa
Facility Name
Research Site
City
Pretoria Gauteng
Country
South Africa
Facility Name
Research Site
City
Western Cape
Country
South Africa
Facility Name
Research Site
City
Barcelone
Country
Spain
Facility Name
Research Site
City
Madrid
Country
Spain
Facility Name
Research Site
City
Pamplona
Country
Spain
Facility Name
Research Site
City
Sabadell, Barcelone
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

EMD 525797 in Subjects With Asymptomatic or Mildly Symptomatic Metastatic Castrate-resistant Prostate Cancer

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