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Phase 3 Study of Immunotherapy to Treat Advanced Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ipilimumab
Placebo
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

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

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Metastatic prostate cancer
  • Asymptomatic or minimally symptomatic
  • Progression during hormonal therapy
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1

Exclusion Criteria:

  • Liver, lung or brain metastases
  • Prior immunotherapy or chemotherapy for metastatic prostate cancer
  • Autoimmune disease
  • HIV, Hepatitis B, or Hepatitis C infection

Sites / Locations

  • Alaska Clinical Research Center, Llc
  • Pinnacle Oncology Hematology
  • Arizona Cancer Center
  • Desert Hematology Oncology
  • Southern California Permanente Medical Group
  • Pacific Hematology Oncology Associates
  • George Washington University
  • Lynn Cancer Institute Center For Hematology-Oncology
  • Baptist Cancer Institute
  • Mount Sinai Comprehensive Cancer Center
  • Md Anderson Cancer Center Orlando
  • Hematology Oncology Associates Of The Treasure Coast
  • Northside Hospital
  • Georgia Regents University
  • Gwinnett Hospital System Inc.
  • Straub Clinic And Hospital
  • University Of Chicago
  • Cancer Care Specialists Of Central Illinois
  • Goshen Center For Cancer Care
  • Hutchinson Clinic, Pa
  • Cancer Center Of Kansas
  • University Of Maryland
  • Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
  • Mayo Clinic
  • Kansas City Veterans Affairs Medical Center
  • Nevada Cancer Institute
  • Comprehensive Cancer Centers Of Nevada
  • Montefiore Medical Center
  • North Shore Hematology/Oncology Associates, P.C.
  • Goshen Medical Associates
  • Stony Brook University Medical Center
  • Suny Upstate Medical University
  • Novant Health Oncology Specialists
  • Tulsa Cancer Institute
  • Kaiser Permanente Oncology/Hematology
  • Oregon Health & Science University
  • St. Luke'S Hospital & Health Network Laboratory
  • Cancer Center Of The Carolinas
  • Carolina Urologic Research Center
  • Scott & White Memorial Hospital And Clinic
  • Utah Cancer Specialists
  • Providence Regional Medical Center Everett
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  • Va Caribbean Healthcare System
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ipilimumab

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Overall Survival (OS) Time
OS was defined as the time from the date of randomization until the date of death. For participants without documentation of death, OS was censored at the last date the participant was known to be alive.

Secondary Outcome Measures

Progression-Free Survival (PFS) Time
Progression-free survival, as determined by the investigator, was defined as the time from randomization to the earliest date of confirmed Prostate-Specific Antigen (PSA) progression, confirmed radiological progression, clinical deterioration, or death.
Time to Subsequent Non-hormonal Cytotoxic Therapy
For participants who discontinued treatment or experienced disease progression while on study therapy and then received subsequent non-hormonal cytotoxic therapy, time to subsequent non-hormonal cytotoxic therapy was defined as the time from randomization to the time of initiation of subsequent non-hormonal cytotoxic therapy. Participants who did not receive subsequent non-hormonal cytotoxic therapy were censored on the last known alive date (for participants who have not died) or the date of last follow-up contact at which the participants was known alive (for participants who died).
Time to Pain Progression
Time to pain progression was defined as the time from randomization to the time of the earliest date of any of the following 4 events: 1) an increase in average daily worst pain intensity of >= 2 points from baseline according to the Brief Pain Inventory - Short Form (BPI-SF), maintained over 2 consecutive time periods. 2) initiation of opioid analgesic (excluding codeine or dextropropoxyphene). 3) initiation of palliative radiotherapy for prostate cancer. 4) increase in mean Analgesic Score (AS) of >= 25% from baseline (for participants with baseline AS > 10) or increase in mean AS >= 10 points from baseline (for participants with baseline AS <= 10). Participants who did not experience any of these events were censored on the earliest date among the latest BPI-SF completion date with non-missing worst pain assessment and last evaluable disease assessment date as defined in the PFS censoring mechanism.
Number of Participants Who Died or Had Adverse Events (AEs), Serious Adverse Events (SAEs), Immune-related AEs (irAEs), or Immune-mediated Adverse Reactions (imARs)
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. irAE=AEs consistent with an immune mediated mechanism. imAR=AEs of special interest that were adjudicated as imAR by investigator. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Number of Treated Participants With Grade 3 or 4 Clinical Laboratory Abnormalities
NCI CTC, Version 3 used to assess parameters. LLN=lower limit of normal. ULN=upper limit of normal. CTC criteria: White blood cells (WBC): Gr 3:<2.0 to 1.0*10^9/L, Gr 4:<1.0*10^9/L. Absolute neutrophil count (ANC): Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L. Platelet count: Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L. Hemoglobin: Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL. Absolute Lymphocyte Count (ALC): Gr 3: 0.2 - <0.5*10^9/L, Gr 4: <0.2*10^9/L. Lipase: Gr 3:> 2.0 - 5.0 * ULN; Gr 4: > 5.0 X ULN. Amylase: Gr 3: > 2.0 - 5.0 * ULN; Gr 4: > 5.0 * ULN. Alanine Aminotransferase (ALT) Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Aspartate Aminotransferase (AST): Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Bilirubin: Gr 3: > 3.0 - 10.0 * ULN; Gr 4: > 10.0 * ULN. Alkaline Phosphatase: Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Creatinine: Gr 3: > 3.0-6.0 * ULN, Gr 4: >6.0 * ULN.

Full Information

First Posted
January 26, 2010
Last Updated
July 11, 2016
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT01057810
Brief Title
Phase 3 Study of Immunotherapy to Treat Advanced Prostate Cancer
Official Title
Randomized, Double-Blind, Phase 3 Trial to Compare the Efficacy of Ipilimumab vs Placebo in Asymptomatic or Minimally Symptomatic Patients With Metastatic Chemotherapy-Naïve Castration Resistant Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine if asymptomatic or minimally symptomatic patients with metastatic prostate cancer who have not received chemotherapy live longer when treated with ipilimumab than those treated with a placebo

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
837 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ipilimumab
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ipilimumab
Other Intervention Name(s)
BMS-734016, MDX010
Intervention Description
5 mg/ml solution, Intravenous, 10 mg/kg, Every 3 weeks for up to 4 doses in the Induction Phase. Every 12 weeks in the Maintenance Phase. Up to 24 weeks in the Induction Phase. Treatment in the Maintenance Phase continues until total treatment period has reached three years,Treatment Stopping Criteria are met, withdrawal of consent, or study closure
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Solution, Intravenous, 0 mg, Every 3 weeks for up to 4 doses in the Induction Phase. Every 12 weeks in the Maintenance Phase. Up to 24 weeks in the Induction Phase. Treatment in the Maintenance Phase continues until total treatment period has reached three years,Treatment Stopping Criteria are met, withdrawal of consent, or study closure
Primary Outcome Measure Information:
Title
Overall Survival (OS) Time
Description
OS was defined as the time from the date of randomization until the date of death. For participants without documentation of death, OS was censored at the last date the participant was known to be alive.
Time Frame
Randomization until death from any cause, up to April 2015, approximately 57 months
Secondary Outcome Measure Information:
Title
Progression-Free Survival (PFS) Time
Description
Progression-free survival, as determined by the investigator, was defined as the time from randomization to the earliest date of confirmed Prostate-Specific Antigen (PSA) progression, confirmed radiological progression, clinical deterioration, or death.
Time Frame
Randomization until disease progression, up to April 2015, approximately 57 months
Title
Time to Subsequent Non-hormonal Cytotoxic Therapy
Description
For participants who discontinued treatment or experienced disease progression while on study therapy and then received subsequent non-hormonal cytotoxic therapy, time to subsequent non-hormonal cytotoxic therapy was defined as the time from randomization to the time of initiation of subsequent non-hormonal cytotoxic therapy. Participants who did not receive subsequent non-hormonal cytotoxic therapy were censored on the last known alive date (for participants who have not died) or the date of last follow-up contact at which the participants was known alive (for participants who died).
Time Frame
Randomization until subsequent non-hormonal cytotoxic therapy, up to April 2015, approximately 57 months
Title
Time to Pain Progression
Description
Time to pain progression was defined as the time from randomization to the time of the earliest date of any of the following 4 events: 1) an increase in average daily worst pain intensity of >= 2 points from baseline according to the Brief Pain Inventory - Short Form (BPI-SF), maintained over 2 consecutive time periods. 2) initiation of opioid analgesic (excluding codeine or dextropropoxyphene). 3) initiation of palliative radiotherapy for prostate cancer. 4) increase in mean Analgesic Score (AS) of >= 25% from baseline (for participants with baseline AS > 10) or increase in mean AS >= 10 points from baseline (for participants with baseline AS <= 10). Participants who did not experience any of these events were censored on the earliest date among the latest BPI-SF completion date with non-missing worst pain assessment and last evaluable disease assessment date as defined in the PFS censoring mechanism.
Time Frame
Randomization until pain progression, up to April 2015, approximately 57 months
Title
Number of Participants Who Died or Had Adverse Events (AEs), Serious Adverse Events (SAEs), Immune-related AEs (irAEs), or Immune-mediated Adverse Reactions (imARs)
Description
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. irAE=AEs consistent with an immune mediated mechanism. imAR=AEs of special interest that were adjudicated as imAR by investigator. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Time Frame
Day 1 of study therapy to last dose plus 70 days
Title
Number of Treated Participants With Grade 3 or 4 Clinical Laboratory Abnormalities
Description
NCI CTC, Version 3 used to assess parameters. LLN=lower limit of normal. ULN=upper limit of normal. CTC criteria: White blood cells (WBC): Gr 3:<2.0 to 1.0*10^9/L, Gr 4:<1.0*10^9/L. Absolute neutrophil count (ANC): Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L. Platelet count: Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L. Hemoglobin: Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL. Absolute Lymphocyte Count (ALC): Gr 3: 0.2 - <0.5*10^9/L, Gr 4: <0.2*10^9/L. Lipase: Gr 3:> 2.0 - 5.0 * ULN; Gr 4: > 5.0 X ULN. Amylase: Gr 3: > 2.0 - 5.0 * ULN; Gr 4: > 5.0 * ULN. Alanine Aminotransferase (ALT) Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Aspartate Aminotransferase (AST): Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Bilirubin: Gr 3: > 3.0 - 10.0 * ULN; Gr 4: > 10.0 * ULN. Alkaline Phosphatase: Gr 3: > 5.0 - 20.0 * ULN; Gr 4: > 20.0 * ULN. Creatinine: Gr 3: > 3.0-6.0 * ULN, Gr 4: >6.0 * ULN.
Time Frame
Randomization up to April 2015, approximately 57 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Metastatic prostate cancer Asymptomatic or minimally symptomatic Progression during hormonal therapy Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 Exclusion Criteria: Liver, lung or brain metastases Prior immunotherapy or chemotherapy for metastatic prostate cancer Autoimmune disease HIV, Hepatitis B, or Hepatitis C infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Alaska Clinical Research Center, Llc
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Pinnacle Oncology Hematology
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Desert Hematology Oncology
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Southern California Permanente Medical Group
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Pacific Hematology Oncology Associates
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
George Washington University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Lynn Cancer Institute Center For Hematology-Oncology
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Baptist Cancer Institute
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Mount Sinai Comprehensive Cancer Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Md Anderson Cancer Center Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Hematology Oncology Associates Of The Treasure Coast
City
Port Saint Lucie
State/Province
Florida
ZIP/Postal Code
34952
Country
United States
Facility Name
Northside Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30341
Country
United States
Facility Name
Georgia Regents University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Gwinnett Hospital System Inc.
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
Straub Clinic And Hospital
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
University Of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Cancer Care Specialists Of Central Illinois
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Goshen Center For Cancer Care
City
Goshen
State/Province
Indiana
ZIP/Postal Code
46526
Country
United States
Facility Name
Hutchinson Clinic, Pa
City
Hutchinson
State/Province
Kansas
ZIP/Postal Code
67502
Country
United States
Facility Name
Cancer Center Of Kansas
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
University Of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Kansas City Veterans Affairs Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64128
Country
United States
Facility Name
Nevada Cancer Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89135
Country
United States
Facility Name
Comprehensive Cancer Centers Of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
North Shore Hematology/Oncology Associates, P.C.
City
East Setauket
State/Province
New York
ZIP/Postal Code
11733
Country
United States
Facility Name
Goshen Medical Associates
City
Goshen
State/Province
New York
ZIP/Postal Code
10924
Country
United States
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Suny Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Novant Health Oncology Specialists
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Tulsa Cancer Institute
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Kaiser Permanente Oncology/Hematology
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
St. Luke'S Hospital & Health Network Laboratory
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Cancer Center Of The Carolinas
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
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
Scott & White Memorial Hospital And Clinic
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Utah Cancer Specialists
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Providence Regional Medical Center Everett
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
Local Institution
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000DSK
Country
Argentina
Facility Name
Local Institution
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000DSV
Country
Argentina
Facility Name
Local Institution
City
Buenos Aires
ZIP/Postal Code
1120
Country
Argentina
Facility Name
Local Institution
City
Buenos Aires
ZIP/Postal Code
C1280AEB
Country
Argentina
Facility Name
Local Institution
City
Buenos Aires
ZIP/Postal Code
C1426BOS
Country
Argentina
Facility Name
Local Institution
City
Cordoba
ZIP/Postal Code
X5006HBF
Country
Argentina
Facility Name
Local Institution
City
La Rioja
ZIP/Postal Code
5300
Country
Argentina
Facility Name
Local Institution
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Local Institution
City
Ashford
State/Province
South Australia
ZIP/Postal Code
5035
Country
Australia
Facility Name
Local Institution
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Local Institution
City
East Bentleigh
State/Province
Victoria
ZIP/Postal Code
3165
Country
Australia
Facility Name
Local Institution
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
Local Institution
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Local Institution
City
Subiaco
State/Province
Western Australia
ZIP/Postal Code
6008
Country
Australia
Facility Name
Local Institution
City
Brasilia
State/Province
Distrito Federal
ZIP/Postal Code
72115
Country
Brazil
Facility Name
Local Institution
City
Belo Horizonte - Mg
State/Province
Minas Gerais
ZIP/Postal Code
31150
Country
Brazil
Facility Name
Local Institution
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30150
Country
Brazil
Facility Name
Local Institution
City
Ijui
State/Province
Rio Grande Do Sul
ZIP/Postal Code
98700
Country
Brazil
Facility Name
Local Institution
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90430
Country
Brazil
Facility Name
Local Institution
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
Facility Name
Local Institution
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Local Institution
City
Temuco
State/Province
Araucania
ZIP/Postal Code
4810469
Country
Chile
Facility Name
Local Institution
City
Vina Del Mar
State/Province
Valparaiso
ZIP/Postal Code
2540364
Country
Chile
Facility Name
Local Institution
City
Santiago
Country
Chile
Facility Name
Local Institution
City
Monteria
State/Province
Cordoba
Country
Colombia
Facility Name
Local Institution
City
Bogota
Country
Colombia
Facility Name
Local Institution
City
Bucaramanga
Country
Colombia
Facility Name
Local Institution
City
Medellin
ZIP/Postal Code
MEDELLIN
Country
Colombia
Facility Name
Local Institution
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czech Republic
Facility Name
Local Institution
City
Liberec
ZIP/Postal Code
460 63
Country
Czech Republic
Facility Name
Local Institution
City
Praha 5
ZIP/Postal Code
150 30
Country
Czech Republic
Facility Name
Local Institution
City
Praha 8
ZIP/Postal Code
180 81
Country
Czech Republic
Facility Name
Local Institution
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Local Institution
City
Kobenhavn O
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Local Institution
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Local Institution
City
Clermont-ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
Local Institution
City
Marseille Cedex 9
ZIP/Postal Code
13273
Country
France
Facility Name
Local Institution
City
Pointe A Pitre
ZIP/Postal Code
97159
Country
France
Facility Name
Local Institution
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
Local Institution
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France
Facility Name
Local Institution
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Local Institution
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Local Institution
City
Marktredwitz
ZIP/Postal Code
95615
Country
Germany
Facility Name
Local Institution
City
Munich
ZIP/Postal Code
81675
Country
Germany
Facility Name
Local Institution
City
Wesel
ZIP/Postal Code
46483
Country
Germany
Facility Name
Local Institution
City
Athens
ZIP/Postal Code
115 28
Country
Greece
Facility Name
Local Institution
City
Budapest
ZIP/Postal Code
1064
Country
Hungary
Facility Name
Local Institution
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
Local Institution
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Local Institution
City
Szekesfehervar
ZIP/Postal Code
H-8000
Country
Hungary
Facility Name
Local Institution
City
Meldola (FC)
ZIP/Postal Code
47014
Country
Italy
Facility Name
Local Institution
City
Milano
ZIP/Postal Code
I-20132
Country
Italy
Facility Name
Local Institution
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Local Institution
City
Terni
ZIP/Postal Code
05100
Country
Italy
Facility Name
Local Institution
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
06726
Country
Mexico
Facility Name
Local Institution
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
07760
Country
Mexico
Facility Name
Local Institution
City
Tlalpan
State/Province
Distrito Federal
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Local Institution
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
Facility Name
Local Institution
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45150
Country
Mexico
Facility Name
Local Institution
City
Mexico
State/Province
Queretaro
ZIP/Postal Code
76200
Country
Mexico
Facility Name
Local Institution
City
San Luis Potosi
ZIP/Postal Code
78240
Country
Mexico
Facility Name
Local Institution
City
Amsterdam
ZIP/Postal Code
1081HV
Country
Netherlands
Facility Name
Local Institution
City
Sittard-geleen
ZIP/Postal Code
6162 BG
Country
Netherlands
Facility Name
Local Institution
City
Kristiansand
ZIP/Postal Code
4604
Country
Norway
Facility Name
Local Institution
City
Gdansk
ZIP/Postal Code
80-402
Country
Poland
Facility Name
Local Institution
City
Koscierzyna
ZIP/Postal Code
83-400
Country
Poland
Facility Name
Local Institution
City
Krakow
ZIP/Postal Code
30-017
Country
Poland
Facility Name
Local Institution
City
Kutno
ZIP/Postal Code
99-300
Country
Poland
Facility Name
Local Institution
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Facility Name
Local Institution
City
Poznan
ZIP/Postal Code
60-693
Country
Poland
Facility Name
Local Institution
City
Slupsk
ZIP/Postal Code
76-200
Country
Poland
Facility Name
Va Caribbean Healthcare System
City
San Juan
ZIP/Postal Code
00921
Country
Puerto Rico
Facility Name
Local Institution
City
Bucuresti
ZIP/Postal Code
022328
Country
Romania
Facility Name
Local Institution
City
Cluj-napoca, Cluj County
ZIP/Postal Code
400046
Country
Romania
Facility Name
Local Institution
City
Timisoara,timis County
ZIP/Postal Code
300376
Country
Romania
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Local Institution
City
Sevilla
ZIP/Postal Code
41071
Country
Spain
Facility Name
Local Institution
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Local Institution
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Local Institution
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Local Institution
City
Vaxjo
ZIP/Postal Code
351 85
Country
Sweden
Facility Name
Local Institution
City
Adana
ZIP/Postal Code
01330
Country
Turkey
Facility Name
Local Institution
City
Bornova, Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Local Institution
City
Gaziantep
ZIP/Postal Code
27310
Country
Turkey
Facility Name
Local Institution
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Facility Name
Local Institution
City
Kocaeli
ZIP/Postal Code
41400
Country
Turkey
Facility Name
Local Institution
City
Glasgow
State/Province
Lanarkshire
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Local Institution
City
Guildford
State/Province
Surrey
ZIP/Postal Code
GU2 7WG
Country
United Kingdom
Facility Name
Local Institution
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B9 5SS
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
24722180
Citation
de Liano AG, Reig O, Mellado B, Martin C, Rull EU, Maroto JP. Prognostic and predictive value of plasma testosterone levels in patients receiving first-line chemotherapy for metastatic castrate-resistant prostate cancer. Br J Cancer. 2014 Apr 29;110(9):2201-8. doi: 10.1038/bjc.2014.189. Epub 2014 Apr 10.
Results Reference
derived
PubMed Identifier
21917607
Citation
Dayyani F, Gallick GE, Logothetis CJ, Corn PG. Novel therapies for metastatic castrate-resistant prostate cancer. J Natl Cancer Inst. 2011 Nov 16;103(22):1665-75. doi: 10.1093/jnci/djr362. Epub 2011 Sep 13.
Results Reference
derived
Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource

Learn more about this trial

Phase 3 Study of Immunotherapy to Treat Advanced Prostate Cancer

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