Back to resultsStudy to Evaluate Safety and Effectiveness of Lenalidomide in Combination With Docetaxel and Prednisone for Patients With Castrate-Resistant Prostate Cancer (Mainsail)
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lenalidomide
Docetaxel
Prednisone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Castrate-Resistant Prostate Cancer, Revlimid, Lenalidomide
Eligibility Criteria
Inclusion Criteria:
- Must sign an Informed Consent Form (ICF)
- Males ≥ 18 years of age
- Able to adhere to the study visit schedule and requirements of the protocol
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
- Life expectancy of ≥ 12 weeks
- Willingness to participate in Patient-Reported Outcomes assessments
- Serum testosterone levels < 50 ng/dL
- Confirmed metastatic adenocarcinoma of the prostate that is unresponsive or refractory to hormonal therapy
- Have documented disease progression while receiving or following hormonal therapy as determined by increasing Serum Prostate Specific Antigen (PSA) level, Radiological Progression, or ≥2 new bone lesions
- Subjects must agree to receive counseling related to pregnancy precautions, teratogenic and other risks of lenalidomide
- Refrain from donating blood or semen as defined by protocol
Exclusion Criteria:
- A history of clinically significant disease that places subject at an unacceptable risk for study entry
- Prior Therapy with thalidomide, lenalidomide or pomalidomide
- Prior chemotherapy for prostate cancer
- Use of any other experimental drug or therapy within 28 days prior to randomization
- Prior radiation to ≥ 30% of bone marrow or any radiation therapy within 28 days prior to randomization
- Prior use of Strontium-89 at any time or Samarium-153 within 56 days prior to randomization
- Surgery within 28 days prior to randomization
- Concurrent anti-androgen therapy
- Abnormal serum chemistry or hematology laboratory values
- Significant active cardiac disease within the previous 6 months:
- Thrombotic or thromboembolic events within the past 6 months:
- History of peripheral neuropathy of ≥grade 2
- History of severe hypersensitivity reaction to drugs formulated with polysorbate 80
- Paraplegia
- History of Central nervous system (CNS) or brain metastases
- History of malignancies other than prostate cancer within the past 5 years, with the exception of treated basal cell/squamous cell carcinoma of the skin
- Concurrent use of alternative cancer therapies
Sites / Locations
- Hematology Oncology Associates
- Northern AZ Hematology and Oncology Assoc
- Arizona Oncology
- City of Hope Cancer Center
- Southwest Cancer Center - Escondido
- Scripps Cancer Center - Clinical Research
- VA Long Beach Healthcare System
- The Angeles Clinc and Research Institute
- University of Southern California
- Prostate Oncology Specialists
- Stanford University Medical Center
- Rocky Mountain Cancer Centers-Colorado Springs Circle
- Washington Cancer Institute
- Melbourne Internal Medicine Associates
- Advanced Medical Specialties
- Florida Cancer Institute - New Hope
- Ocala Oncology Center
- Cancer Centers of Florida, P.A.- West Gore Street
- South Florida Oncology - Hematology
- Palm Beach Cancer Institute, LLC
- Cancer Care and Hematology Specialists of Chicagoland
- Lutheran General Hospital
- Indiana University Health
- Hematology and Oncology Specialist, LLC
- Maryland Oncology Hematology PA
- Minnesota Oncology Hematology, PA
- Missouri Cancer Associates
- Comprehensive Cancer Centers of Nevada
- Summit Medical Group Overlook Oncology Center
- Hematology-Oncology Associates of NNJ, P
- Hematology Oncology Associates of South Jersey
- New York Oncology Hematology P.C.
- Columbia Univ Medical Center
- Weill Cornell Medical College Dr. Feldman's Office
- New Bern Cancer Care
- Cancer Centers of North Carolina
- Mid Dakota Clinic, PC
- Oncology Hematology Care, Inc.
- Northwest Cancer Specialists-Tualatin
- Ralph H. Johnson VA Medical Center
- South Carolina Oncology Associates, PA
- Cancer Center of the Carolinas
- Chattanooga Oncology Hematology Associates
- Cookeville Regional Medical Center
- Sarah Cannon Research Institute UK
- Texas Oncology, P.A.-Amarillo
- Texas Oncology-Arlington South
- Texas Oncology, PA
- Baylor Sammons Cancer Center
- Texas Oncology, P.A.-Fort Worth
- Longview Cancer Center
- Allison Cancer Center
- Texas Oncology, P.A. - Paris
- Southlake Oncology
- Texas Oncology, P.A. - Tyler
- Texas Oncology Deke Slayton Cancer Center
- Texas Oncology-Texoma Cancer Center
- Veterans Education and Research Association of Northern New England, Inc.
- Cancer Outreach Associates
- Fairfax Northern Virginia Hematology Oncology
- Virginia Oncology Associates
- Virginia Cancer Institute
- Oncology and Hematology Associates of Southwest Virginia, Inc.
- Columbia Basin Hematology and Oncology
- VA Puget Sound HCS Seattle Division
- Evergreen Hematology and Oncology
- Royal Adelaide Hospital
- Royal Melbourne Hospital
- Flinders Medical Centre
- Chris O'Brien Lifehouse
- Sir Charles Gairdner Hospital
- Port Macquarie Base Hospital
- Redcliffe Hospital
- Royal North Shore Hospital
- Newcastle Calvary Mater Hospital
- Westmead Hospital
- Border Medical Oncology
- The Queen Elizabeth Hospital
- Princess Alexandra Hospital
- Medical University of Graz
- Landeskrankenhaus Salzburg
- Krankenhaus der Barmherzigen Brueder
- Medizinische Universitat Wien
- ZNA Middelheim
- Hopital Erasme
- Edith Cavell Clinic
- AZ Groeninge
- UZ Leuven
- AZ Nikolaas
- The Health Institute for Men CMX Research Inc
- Les Urologues Specialises
- Krajska zdravotni, a.s. Nemocnice Chomutov, o.z.
- Fakultni nemocnice Motol
- Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad La
- Arhus Universitets hospital
- Herlev Hospital
- Rigshospitalet University Hospital
- Odense Universitetshospital
- CRLCC Paul Papin
- Institut Bergonie Centre Regional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest
- Centre Georges Francois Leclerc
- Clinique Victor Hugo
- Centre Oscar Lambret
- Centre Leon Berard
- Clinique de Valdegour
- CHU de Poitiers
- Centre Eugene Marquis
- CRLCC Centre Rene Gauducheau
- Institut de Cancerologie de la Loire
- Hopital Civil de Strasbourg
- CHRU Hopital Bretonneau
- Institut Gustave Roussy
- Vivantes Klinikum am Urban
- Medizinisches Zentrum Bonn-Friedensplatz
- Diakonissenkrankenhaus Dessau gGmbH
- Universitaetsklinikum Duesseldorf
- Krankenhaus Nordwest
- Onkologische Praxis Freiburg
- Universitatsklinikum Hamburg-Eppendorf / IVDP
- IORC- Innovation Onkologie Research and Consulting GmbH
- Praxis fuer Haematologie und Onkologie Koblenz
- Vituro GmbH & Co KG
- TU München - Klinikum rechts der Isar
- Universitaetsklinikum Muenster
- University-Hospital Tübingen
- Universitatsklinikum Ulm
- Alexandra General Hospital of Athens
- Agioi Anargyroi Hospital
- University Hospital of Larissa
- Papageorgiou General Hospital of Thessaloniki
- Fovarosi Onkirmanyzat Peterfy S.Utcai Korhaz-Rend.Int es Baleseti Kozp.
- Fovarosi Onkormanyzat Bajcsy-Zsilinszky Korhaz es Rendelointezet
- Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
- Pecsi Tudomanyegytem Altalanos Orvostudomanyi Kar
- The Soroka University Medical Center
- Rambam Health Care Campus
- Rabin Medical Center
- Assaf Harofeh Medical Center
- Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
- Ordine Mauriziano
- Azienda Ospedaliera Istituti Ospitalieri di Cremona
- Ospedale Vito Fazzi
- Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.)
- Ospedale di Mirano
- Azienda Ospedaliero Universitaria Pisana
- Ospedale degli Infermi di Rimini
- Azienda Ospedaliera San Camillo Forlanini
- Azienda Ospedaliero-Universitaria Santa Maria della Miserico
- Hospital Angeles Lindavista
- Consultorio de Especialidad en Urologia Privado
- Hospital Fatima
- Consultorio Privado- Dr Jose Arturo Rodriguez Rivera
- VU University Medical Center VU Medisch Centrum
- Ziekenhuis Rijnstate
- Amphia Ziekenhuis Molengracht
- HagaZiekenhuis
- Gemini Ziekenhuis
- Albert Schweitzer Ziekenhuis Amstelwijck
- Catharina Ziekenhuis
- Medisch Centrum Leeuwarden
- Leids Universitair Medisch Centrum
- Academisch Ziekenhuis Maastricht
- St. Antonius Ziekenhuis Nieuwegein
- Erasmus Medical Center
- Erasmus Medisch Centrum
- Twee Steden Ziekenhuis Tilburg
- VieCuri Medisch Centrum Venlo
- Isala Klinieken
- Uniwersyteckie Centrum Kliniczne
- Regionalny Osrodek Onkologiczny WSS im. M. Kopernika
- ZOZ MSWiA z Warminsko- Mazurskim Centrum Onkologii
- NZOZ Olsztynski Osr. Onkologiczny Kopernik Sp.z o.o
- SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 w Rybniku
- Centrum Onkologii-Instytut im.Marii Sklodowskiej-Curie
- 4 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ
- Moscow Oncology Clinical Dispensary 1
- Medical Radiology Research Centre RAMS
- State Institution of Heath Omsk Regional Oncology Dispensary
- Russian Scientific Center for Radiology and Surgical Technol, St. Petersburg
- NSHI Dorozhnaya Clinical Hospital of OAO Russian Railways
- Oncology Dispensary 2 of Krasnodar Region
- Yaroslavl Regional Clinical Oncology Hospital
- Groote Schuur Hospital
- The Oncology Centre Durban
- Westridge Medical Centre
- Netcare Oncology and Interventional Centre
- Dr. H. Malan
- Pretoria Urology Hospital
- Hospital del Mar
- Hospital Durán i Reynals - Instituto Catalàn de Oncologìa ICO
- Hospital Arnau de Vilanova
- Hospital 12 de Octobre
- HCU Virgen de la Victoria
- Clinica Universitaria de Navarra
- Hospital Mutua de Terrassa
- Hospital Clinico Universitario de Valencia
- Hospital Universitario Miguel Servet
- Lanssjukhuset Ryhov
- Norrlands Universitetssjukhus
- Centrallasarettet Vasteras
- Clatterbridge Centre for Oncology NHS Trust
- Addenbrookes Hospital
- Royal Surrey County Hospital
- Guy's and St Thomas' Hospital - London
- St George's Hospital
- Royal Marsden Hospital
- Christie NHS Trust Hospital
- Nottingham City Hospital
- Northern Lincolnshire and Goole Hospitals NHS Foundation Trust
- Royal Marsden Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Docetaxel, Prednisone, Lenalidomide (DPL)
Docetaxel and Prednisone (DP)
Arm Description
25 mg lenalidomide orally once each day on Days 1-14; 75 mg/m2 docetaxel intravenously on Day 1; 5 mg prednisone orally twice daily on each day of the treatment cycle
Oral placebo once each day on Days 1-14 of the treatment cycle; 75 mg/m2 docetaxel intravenously on Day 1; 5 mg prednisone orally twice each day on each day of the treatment cycle
Outcomes
Primary Outcome Measures
Overall Survival (OS)
Overall survival (OS) was the time from the date of randomization to the date of death from any cause. If no death was reported for a participant before the cut-off date for OS analysis, OS was censored at the last date at which the participant was alive. The median OS was calculated based on Kaplan-Meier estimates and corresponding 95% confidence interval (CI) was calculated using the method provided by Brookmeyer and Crowley.
Secondary Outcome Measures
Progression-Free Survival (PFS)
PFS was the time from randomization to disease progression, or death, whatever occurred first. Progression criteria was met by analysis of target and non-target lesions as defined by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria. Progressive Disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum of the diameters while on study or the appearance of one or more new lesions; an increase of at least 5mm as a total sum. Lymph nodes identified as target lesions (≥ 15 mm diameter in short axis) will be followed and reported by changes in diameter of short axis; or the unequivocal progression of a non-target lesion defined as an increase in the overall disease burden based on the change in non-measurable disease that is comparable in scope to the increase required to declare PD for measurable disease; Two or more new bone lesions as detected by bone scan
Percentage of Participants With an Objective Response According to Response Evaluation Criteria in Solid Tumors - RECIST Version 1.1 Criteria
Objective response (OR) is defined as having complete response (CR) or partial response (PR) as best overall response based on RECIST Criteria 1.1 and defines a CR = Disappearance of all target lesions except lymph nodes (LN); LN must have a decrease in the short axis to <10mm; PR = 30% decrease in sum of diameters of target lesions taking as reference the baseline sum diameters; Progressed Disease (PD) = 20% increase in sum of diameters of target lesions taking as a reference the smallest sum of diameters and an absolute increase of ≥5 mm; the appearance of ≥1 new lesions; Stable Disease (SD)= Neither shrinkage to qualify for PR nor increase to qualify for PD taking the smallest sum diameters on study as reference. For non-target lesions a CR = Disappearance of all non-target lesions and all LN must be non-pathological in size <10 mm; Non-CR/Non PD: persistence of one or more non-target lesions; PD = unequivocal progression of existing non-target lesions or appearance of new ones
Number of Participants With Treatment Emergent Adverse Events (AEs)
A TEAE is defined as any AE occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug. A TESAE is defined as any serious adverse event (SAE) occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug. Safety and severity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0; Severity of AEs were graded (including second primary malignancies) as Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe; Grade 4- Life-threatening; Grade 5-Fatal;
Percentage of Participants Who Received Post-Study Therapies
Percentage of Participants Who Received Post-Study Therapies for advanced Prostate Cancer.
Percentage of Participants With Secondary Primary Malignancies During the Course of the Trial
Second primary malignancies were monitored as events of interest and reported as serious adverse events throughout the course of the trial.
Time to Onset of Secondary Primary Malignancies
Time of Onset of Secondary Primary Malignancies was considered an event of interest
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00988208
Brief Title
Study to Evaluate Safety and Effectiveness of Lenalidomide in Combination With Docetaxel and Prednisone for Patients With Castrate-Resistant Prostate Cancer
Acronym
Mainsail
Official Title
A Phase 3 Study to Evaluate the Efficacy and Safety of Docetaxel and Prednisone With or Without Lenalidomide in Subjects With Castrate-Resistant Prostate Cancer (CRPC)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
November 11, 2009 (Actual)
Primary Completion Date
January 13, 2012 (Actual)
Study Completion Date
November 28, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the study is to determine whether lenalidomide is safe and effective for use in combination with docetaxel and prednisone for the treatment of subjects with metastatic Castrate-Resistant Prostate Cancer.
The addition of lenalidomide to docetaxel and prednisone is proposed to increase the life expectancy of these subjects.
Detailed Description
In November 2011, the Data Monitoring Committee concluded it was unlikely that the study would meet its primary endpoint of overall survival (OS) and recommended that the study be stopped. The study was terminated in accordance with this recommendation. All sites were instructed to immediately discontinue all patients from experimental lenalidomide/placebo treatment administered either in combination with chemotherapy or as a single agent following chemotherapy discontinuation. Subsequently, Protocol Amendment 3 was issued to provide for the following:
To continue to collect information on Second Primary Malignancies (SPMs) and additional treatments for Prostate Cancer in all randomized subjects during survival follow-up.
To continue to provide docetaxel and prednisone for up to 10 cycles to subjects randomized at non-US sites who were ongoing in the CC-5013-PC-002 protocol when the decision was made to discontinue lenalidomide/placebo and who were experiencing benefit as per investigator discretion. For subjects who had exceeded 10 cycles of docetaxel and prednisone at the time of Protocol Amendment 3 approval, an additional two cycles were provided.
All references to dosing and study procedures pertaining to the safety, efficacy, and exploratory endpoints of lenalidomide/placebo were discontinued as part of Protocol Amendment 3.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Castrate-Resistant Prostate Cancer, Revlimid, Lenalidomide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1059 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Docetaxel, Prednisone, Lenalidomide (DPL)
Arm Type
Experimental
Arm Description
25 mg lenalidomide orally once each day on Days 1-14; 75 mg/m2 docetaxel intravenously on Day 1; 5 mg prednisone orally twice daily on each day of the treatment cycle
Arm Title
Docetaxel and Prednisone (DP)
Arm Type
Experimental
Arm Description
Oral placebo once each day on Days 1-14 of the treatment cycle; 75 mg/m2 docetaxel intravenously on Day 1; 5 mg prednisone orally twice each day on each day of the treatment cycle
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Other Intervention Name(s)
CC-5013, Revlimid
Intervention Description
25 mg lenalidomide orally once each day on Days 1-14
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
75 mg/m2 intravenous docetaxel on Day 1
Intervention Type
Drug
Intervention Name(s)
Prednisone
Other Intervention Name(s)
There are multiple brand names for prednisone.
Intervention Description
5 mg prednisone orally twice daily on each day of the treatment cycle
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral placebo once each day on Days 1-14 of the treatment cycle
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Overall survival (OS) was the time from the date of randomization to the date of death from any cause. If no death was reported for a participant before the cut-off date for OS analysis, OS was censored at the last date at which the participant was alive. The median OS was calculated based on Kaplan-Meier estimates and corresponding 95% confidence interval (CI) was calculated using the method provided by Brookmeyer and Crowley.
Time Frame
From randomization until death from any cause up to the cut-off date of 13 January 2012; up to approximately 26 months
Secondary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
PFS was the time from randomization to disease progression, or death, whatever occurred first. Progression criteria was met by analysis of target and non-target lesions as defined by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria. Progressive Disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum of the diameters while on study or the appearance of one or more new lesions; an increase of at least 5mm as a total sum. Lymph nodes identified as target lesions (≥ 15 mm diameter in short axis) will be followed and reported by changes in diameter of short axis; or the unequivocal progression of a non-target lesion defined as an increase in the overall disease burden based on the change in non-measurable disease that is comparable in scope to the increase required to declare PD for measurable disease; Two or more new bone lesions as detected by bone scan
Time Frame
From randomization until disease progression or death from any cause; up to the cut-off date of 13 Jan 2012; maximum time on study was approximately 26 months
Title
Percentage of Participants With an Objective Response According to Response Evaluation Criteria in Solid Tumors - RECIST Version 1.1 Criteria
Description
Objective response (OR) is defined as having complete response (CR) or partial response (PR) as best overall response based on RECIST Criteria 1.1 and defines a CR = Disappearance of all target lesions except lymph nodes (LN); LN must have a decrease in the short axis to <10mm; PR = 30% decrease in sum of diameters of target lesions taking as reference the baseline sum diameters; Progressed Disease (PD) = 20% increase in sum of diameters of target lesions taking as a reference the smallest sum of diameters and an absolute increase of ≥5 mm; the appearance of ≥1 new lesions; Stable Disease (SD)= Neither shrinkage to qualify for PR nor increase to qualify for PD taking the smallest sum diameters on study as reference. For non-target lesions a CR = Disappearance of all non-target lesions and all LN must be non-pathological in size <10 mm; Non-CR/Non PD: persistence of one or more non-target lesions; PD = unequivocal progression of existing non-target lesions or appearance of new ones
Time Frame
From day 1 to data cut-off 13 January 2012; maximum time on study was approximately 26 months
Title
Number of Participants With Treatment Emergent Adverse Events (AEs)
Description
A TEAE is defined as any AE occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug. A TESAE is defined as any serious adverse event (SAE) occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug. Safety and severity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0; Severity of AEs were graded (including second primary malignancies) as Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe; Grade 4- Life-threatening; Grade 5-Fatal;
Time Frame
From the time from of first dose of study drug administration to 28 days after the last dose of study drug and up to the data cut off date of 13 January 2012; the maximum duration of study drug was 93 weeks for DP and 90.6 weeks for DPL
Title
Percentage of Participants Who Received Post-Study Therapies
Description
Percentage of Participants Who Received Post-Study Therapies for advanced Prostate Cancer.
Time Frame
The date when the first consent form was signed to the last date of AE data collection;up to 5 years; up to the date of the final data analysis date of 20 April 2017
Title
Percentage of Participants With Secondary Primary Malignancies During the Course of the Trial
Description
Second primary malignancies were monitored as events of interest and reported as serious adverse events throughout the course of the trial.
Time Frame
The date when the first consent form was signed to the last date of AE data collection; up to the date of the final data analysis date of 30 November 2016; 7 years and 19 days
Title
Time to Onset of Secondary Primary Malignancies
Description
Time of Onset of Secondary Primary Malignancies was considered an event of interest
Time Frame
The date when the first consent form was signed to the last date of AE data collection; up to the date of the final data analysis date of 30 November 2016; 7 years and 19 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must sign an Informed Consent Form (ICF)
Males ≥ 18 years of age
Able to adhere to the study visit schedule and requirements of the protocol
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
Life expectancy of ≥ 12 weeks
Willingness to participate in Patient-Reported Outcomes assessments
Serum testosterone levels < 50 ng/dL
Confirmed metastatic adenocarcinoma of the prostate that is unresponsive or refractory to hormonal therapy
Have documented disease progression while receiving or following hormonal therapy as determined by increasing Serum Prostate Specific Antigen (PSA) level, Radiological Progression, or ≥2 new bone lesions
Subjects must agree to receive counseling related to pregnancy precautions, teratogenic and other risks of lenalidomide
Refrain from donating blood or semen as defined by protocol
Exclusion Criteria:
A history of clinically significant disease that places subject at an unacceptable risk for study entry
Prior Therapy with thalidomide, lenalidomide or pomalidomide
Prior chemotherapy for prostate cancer
Use of any other experimental drug or therapy within 28 days prior to randomization
Prior radiation to ≥ 30% of bone marrow or any radiation therapy within 28 days prior to randomization
Prior use of Strontium-89 at any time or Samarium-153 within 56 days prior to randomization
Surgery within 28 days prior to randomization
Concurrent anti-androgen therapy
Abnormal serum chemistry or hematology laboratory values
Significant active cardiac disease within the previous 6 months:
Thrombotic or thromboembolic events within the past 6 months:
History of peripheral neuropathy of ≥grade 2
History of severe hypersensitivity reaction to drugs formulated with polysorbate 80
Paraplegia
History of Central nervous system (CNS) or brain metastases
History of malignancies other than prostate cancer within the past 5 years, with the exception of treated basal cell/squamous cell carcinoma of the skin
Concurrent use of alternative cancer therapies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Debora Barton, MD
Organizational Affiliation
Celgene Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Hematology Oncology Associates
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Northern AZ Hematology and Oncology Assoc
City
Sedona
State/Province
Arizona
ZIP/Postal Code
86336
Country
United States
Facility Name
Arizona Oncology
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
City of Hope Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States
Facility Name
Southwest Cancer Center - Escondido
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
Scripps Cancer Center - Clinical Research
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
VA Long Beach Healthcare System
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
The Angeles Clinc and Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Prostate Oncology Specialists
City
Marina Del Rey
State/Province
California
ZIP/Postal Code
90292
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94035-5821
Country
United States
Facility Name
Rocky Mountain Cancer Centers-Colorado Springs Circle
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Washington Cancer Institute
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Melbourne Internal Medicine Associates
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
Advanced Medical Specialties
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Florida Cancer Institute - New Hope
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
Facility Name
Ocala Oncology Center
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Cancer Centers of Florida, P.A.- West Gore Street
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
South Florida Oncology - Hematology
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Palm Beach Cancer Institute, LLC
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Cancer Care and Hematology Specialists of Chicagoland
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
Facility Name
Lutheran General Hospital
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
Indiana University Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46219
Country
United States
Facility Name
Hematology and Oncology Specialist, LLC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Maryland Oncology Hematology PA
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044
Country
United States
Facility Name
Minnesota Oncology Hematology, PA
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Missouri Cancer Associates
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
Summit Medical Group Overlook Oncology Center
City
Berkeley Heights
State/Province
New Jersey
ZIP/Postal Code
07922
Country
United States
Facility Name
Hematology-Oncology Associates of NNJ, P
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Hematology Oncology Associates of South Jersey
City
Mount Holly
State/Province
New Jersey
ZIP/Postal Code
08060
Country
United States
Facility Name
New York Oncology Hematology P.C.
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Columbia Univ Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Weill Cornell Medical College Dr. Feldman's Office
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
New Bern Cancer Care
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
Facility Name
Cancer Centers of North Carolina
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Mid Dakota Clinic, PC
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Oncology Hematology Care, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Northwest Cancer Specialists-Tualatin
City
Tualatin
State/Province
Oregon
ZIP/Postal Code
97062
Country
United States
Facility Name
Ralph H. Johnson VA Medical Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
Facility Name
South Carolina Oncology Associates, PA
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29210
Country
United States
Facility Name
Cancer Center of the Carolinas
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Facility Name
Chattanooga Oncology Hematology Associates
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Cookeville Regional Medical Center
City
Cookeville
State/Province
Tennessee
ZIP/Postal Code
38501
Country
United States
Facility Name
Sarah Cannon Research Institute UK
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203-1632
Country
United States
Facility Name
Texas Oncology, P.A.-Amarillo
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Texas Oncology-Arlington South
City
Arlington
State/Province
Texas
ZIP/Postal Code
76014
Country
United States
Facility Name
Texas Oncology, PA
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
Baylor Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Texas Oncology, P.A.-Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Longview Cancer Center
City
Longview
State/Province
Texas
ZIP/Postal Code
75601
Country
United States
Facility Name
Allison Cancer Center
City
Midland
State/Province
Texas
ZIP/Postal Code
79701
Country
United States
Facility Name
Texas Oncology, P.A. - Paris
City
Paris
State/Province
Texas
ZIP/Postal Code
75460
Country
United States
Facility Name
Southlake Oncology
City
Southlake
State/Province
Texas
ZIP/Postal Code
76092
Country
United States
Facility Name
Texas Oncology, P.A. - Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Texas Oncology Deke Slayton Cancer Center
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Texas Oncology-Texoma Cancer Center
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76310
Country
United States
Facility Name
Veterans Education and Research Association of Northern New England, Inc.
City
White River Junction
State/Province
Vermont
ZIP/Postal Code
05009
Country
United States
Facility Name
Cancer Outreach Associates
City
Abingdon
State/Province
Virginia
ZIP/Postal Code
24211
Country
United States
Facility Name
Fairfax Northern Virginia Hematology Oncology
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Virginia Oncology Associates
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Virginia Cancer Institute
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Facility Name
Oncology and Hematology Associates of Southwest Virginia, Inc.
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Columbia Basin Hematology and Oncology
City
Kennewick
State/Province
Washington
ZIP/Postal Code
99336
Country
United States
Facility Name
VA Puget Sound HCS Seattle Division
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108-1532
Country
United States
Facility Name
Evergreen Hematology and Oncology
City
Spokane
State/Province
Washington
ZIP/Postal Code
99218
Country
United States
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
SA 5000
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Flinders Medical Centre
City
Bedford Park
ZIP/Postal Code
5042
Country
Australia
Facility Name
Chris O'Brien Lifehouse
City
Camperdown
ZIP/Postal Code
NSW 2050
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
ZIP/Postal Code
6009
Country
Australia
Facility Name
Port Macquarie Base Hospital
City
Port Macquarie
ZIP/Postal Code
NSW 2444
Country
Australia
Facility Name
Redcliffe Hospital
City
Redcliffe
ZIP/Postal Code
QLD 4020
Country
Australia
Facility Name
Royal North Shore Hospital
City
St Leonards
ZIP/Postal Code
2065
Country
Australia
Facility Name
Newcastle Calvary Mater Hospital
City
Waratah
ZIP/Postal Code
2298
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
ZIP/Postal Code
NSW 2145
Country
Australia
Facility Name
Border Medical Oncology
City
Wodonga
ZIP/Postal Code
3690
Country
Australia
Facility Name
The Queen Elizabeth Hospital
City
Woodville South
ZIP/Postal Code
5011
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
ZIP/Postal Code
QLD 4102
Country
Australia
Facility Name
Medical University of Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Landeskrankenhaus Salzburg
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Krankenhaus der Barmherzigen Brueder
City
Vienna
ZIP/Postal Code
1020
Country
Austria
Facility Name
Medizinische Universitat Wien
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
ZNA Middelheim
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Facility Name
Hopital Erasme
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Edith Cavell Clinic
City
Bruxelles
ZIP/Postal Code
1180
Country
Belgium
Facility Name
AZ Groeninge
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
AZ Nikolaas
City
Sint-Niklaas
ZIP/Postal Code
9100
Country
Belgium
Facility Name
The Health Institute for Men CMX Research Inc
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M1P 2T7
Country
Canada
Facility Name
Les Urologues Specialises
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 1N8
Country
Canada
Facility Name
Krajska zdravotni, a.s. Nemocnice Chomutov, o.z.
City
Chomutov
ZIP/Postal Code
430 12
Country
Czechia
Facility Name
Fakultni nemocnice Motol
City
Prague 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad La
City
Usti Nad Labem
ZIP/Postal Code
40113
Country
Czechia
Facility Name
Arhus Universitets hospital
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Herlev Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Rigshospitalet University Hospital
City
Kobenhavn
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Odense Universitetshospital
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
CRLCC Paul Papin
City
Angers 49
ZIP/Postal Code
49933
Country
France
Facility Name
Institut Bergonie Centre Regional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Centre Georges Francois Leclerc
City
Dijon Cedex
ZIP/Postal Code
21079
Country
France
Facility Name
Clinique Victor Hugo
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
Centre Oscar Lambret
City
Lille 59
ZIP/Postal Code
59020
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Clinique de Valdegour
City
Nimes
ZIP/Postal Code
30900
Country
France
Facility Name
CHU de Poitiers
City
Poitiers Cedex
ZIP/Postal Code
86021
Country
France
Facility Name
Centre Eugene Marquis
City
Rennes Cedex
ZIP/Postal Code
35042
Country
France
Facility Name
CRLCC Centre Rene Gauducheau
City
Saint Herblain 44
ZIP/Postal Code
44805
Country
France
Facility Name
Institut de Cancerologie de la Loire
City
Saint Priest En Jaroz
ZIP/Postal Code
42270
Country
France
Facility Name
Hopital Civil de Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
CHRU Hopital Bretonneau
City
Tours Cedex
ZIP/Postal Code
37044
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Vivantes Klinikum am Urban
City
Berlin
ZIP/Postal Code
10967
Country
Germany
Facility Name
Medizinisches Zentrum Bonn-Friedensplatz
City
Bonn
ZIP/Postal Code
53111
Country
Germany
Facility Name
Diakonissenkrankenhaus Dessau gGmbH
City
Dessau-Rosslau
ZIP/Postal Code
06846
Country
Germany
Facility Name
Universitaetsklinikum Duesseldorf
City
Duesseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Krankenhaus Nordwest
City
Frankfurt a.M.
ZIP/Postal Code
60488
Country
Germany
Facility Name
Onkologische Praxis Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Universitatsklinikum Hamburg-Eppendorf / IVDP
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
IORC- Innovation Onkologie Research and Consulting GmbH
City
Hamburg
ZIP/Postal Code
22081
Country
Germany
Facility Name
Praxis fuer Haematologie und Onkologie Koblenz
City
Koblenz
ZIP/Postal Code
56068
Country
Germany
Facility Name
Vituro GmbH & Co KG
City
Leipzig
ZIP/Postal Code
4277
Country
Germany
Facility Name
TU München - Klinikum rechts der Isar
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
Universitaetsklinikum Muenster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
University-Hospital Tübingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universitatsklinikum Ulm
City
Ulm
ZIP/Postal Code
89075
Country
Germany
Facility Name
Alexandra General Hospital of Athens
City
Athens
ZIP/Postal Code
11528
Country
Greece
Facility Name
Agioi Anargyroi Hospital
City
Athens
ZIP/Postal Code
14564
Country
Greece
Facility Name
University Hospital of Larissa
City
Larissa
ZIP/Postal Code
41110
Country
Greece
Facility Name
Papageorgiou General Hospital of Thessaloniki
City
Thessaloniki
ZIP/Postal Code
56429
Country
Greece
Facility Name
Fovarosi Onkirmanyzat Peterfy S.Utcai Korhaz-Rend.Int es Baleseti Kozp.
City
Budapest
ZIP/Postal Code
1076
Country
Hungary
Facility Name
Fovarosi Onkormanyzat Bajcsy-Zsilinszky Korhaz es Rendelointezet
City
Budapest
ZIP/Postal Code
1106
Country
Hungary
Facility Name
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Facility Name
Pecsi Tudomanyegytem Altalanos Orvostudomanyi Kar
City
Pecs
ZIP/Postal Code
7623
Country
Hungary
Facility Name
The Soroka University Medical Center
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Rabin Medical Center
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Assaf Harofeh Medical Center
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
Facility Name
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Ordine Mauriziano
City
Candiolo
ZIP/Postal Code
10023
Country
Italy
Facility Name
Azienda Ospedaliera Istituti Ospitalieri di Cremona
City
Cremona
ZIP/Postal Code
23100
Country
Italy
Facility Name
Ospedale Vito Fazzi
City
Lecce
ZIP/Postal Code
73100
Country
Italy
Facility Name
Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.)
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Facility Name
Ospedale di Mirano
City
Mirano (VE)
ZIP/Postal Code
30035
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Pisana
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Ospedale degli Infermi di Rimini
City
Rimini
ZIP/Postal Code
47900
Country
Italy
Facility Name
Azienda Ospedaliera San Camillo Forlanini
City
Roma
ZIP/Postal Code
00149
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Santa Maria della Miserico
City
Udine
ZIP/Postal Code
70124
Country
Italy
Facility Name
Hospital Angeles Lindavista
City
D.f, Df
ZIP/Postal Code
07760
Country
Mexico
Facility Name
Consultorio de Especialidad en Urologia Privado
City
Durango, DGO
ZIP/Postal Code
34000
Country
Mexico
Facility Name
Hospital Fatima
City
Sinaloa, SIN
ZIP/Postal Code
81200
Country
Mexico
Facility Name
Consultorio Privado- Dr Jose Arturo Rodriguez Rivera
City
Zapopan, JAL
ZIP/Postal Code
45040
Country
Mexico
Facility Name
VU University Medical Center VU Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Ziekenhuis Rijnstate
City
Arhem
ZIP/Postal Code
6800 TA
Country
Netherlands
Facility Name
Amphia Ziekenhuis Molengracht
City
Breda
ZIP/Postal Code
4818 CK
Country
Netherlands
Facility Name
HagaZiekenhuis
City
Den Haag
ZIP/Postal Code
2545 CH
Country
Netherlands
Facility Name
Gemini Ziekenhuis
City
Den Helder
ZIP/Postal Code
1782 GZ
Country
Netherlands
Facility Name
Albert Schweitzer Ziekenhuis Amstelwijck
City
Dordrecht
ZIP/Postal Code
3317 NM
Country
Netherlands
Facility Name
Catharina Ziekenhuis
City
Eindhoven
ZIP/Postal Code
5632 EJ
Country
Netherlands
Facility Name
Medisch Centrum Leeuwarden
City
Leeuwarden
ZIP/Postal Code
8934 AD
Country
Netherlands
Facility Name
Leids Universitair Medisch Centrum
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
Academisch Ziekenhuis Maastricht
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
St. Antonius Ziekenhuis Nieuwegein
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
Facility Name
Erasmus Medical Center
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Facility Name
Erasmus Medisch Centrum
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Facility Name
Twee Steden Ziekenhuis Tilburg
City
Tilburg
ZIP/Postal Code
5042 AD
Country
Netherlands
Facility Name
VieCuri Medisch Centrum Venlo
City
Venlo
ZIP/Postal Code
5912 BL
Country
Netherlands
Facility Name
Isala Klinieken
City
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Regionalny Osrodek Onkologiczny WSS im. M. Kopernika
City
Lodz
ZIP/Postal Code
93-509
Country
Poland
Facility Name
ZOZ MSWiA z Warminsko- Mazurskim Centrum Onkologii
City
Olsztyn
ZIP/Postal Code
10-228
Country
Poland
Facility Name
NZOZ Olsztynski Osr. Onkologiczny Kopernik Sp.z o.o
City
Olsztyn
ZIP/Postal Code
10-513
Country
Poland
Facility Name
SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 w Rybniku
City
Rybnik
ZIP/Postal Code
44-200
Country
Poland
Facility Name
Centrum Onkologii-Instytut im.Marii Sklodowskiej-Curie
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
4 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ
City
Wroclaw
ZIP/Postal Code
50-981
Country
Poland
Facility Name
Moscow Oncology Clinical Dispensary 1
City
Moscow
ZIP/Postal Code
105005
Country
Russian Federation
Facility Name
Medical Radiology Research Centre RAMS
City
Obninsk
ZIP/Postal Code
249036
Country
Russian Federation
Facility Name
State Institution of Heath Omsk Regional Oncology Dispensary
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
Russian Scientific Center for Radiology and Surgical Technol, St. Petersburg
City
Pesochny Vlg Saint Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
NSHI Dorozhnaya Clinical Hospital of OAO Russian Railways
City
Rostov-on-Don
ZIP/Postal Code
344011
Country
Russian Federation
Facility Name
Oncology Dispensary 2 of Krasnodar Region
City
Sochi
ZIP/Postal Code
354057
Country
Russian Federation
Facility Name
Yaroslavl Regional Clinical Oncology Hospital
City
Yaroslavl
ZIP/Postal Code
150054
Country
Russian Federation
Facility Name
Groote Schuur Hospital
City
Cape Town, W Cape
ZIP/Postal Code
7925
Country
South Africa
Facility Name
The Oncology Centre Durban
City
Durban, KZ-Natal
ZIP/Postal Code
4091
Country
South Africa
Facility Name
Westridge Medical Centre
City
Durban, KZ-Natal
ZIP/Postal Code
4091
Country
South Africa
Facility Name
Netcare Oncology and Interventional Centre
City
Goodwood, W Cape
ZIP/Postal Code
7460
Country
South Africa
Facility Name
Dr. H. Malan
City
Polokwane
ZIP/Postal Code
699
Country
South Africa
Facility Name
Pretoria Urology Hospital
City
Pretoria
ZIP/Postal Code
0083
Country
South Africa
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Durán i Reynals - Instituto Catalàn de Oncologìa ICO
City
Hospitalet de Llobregat, Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Arnau de Vilanova
City
Lérida
ZIP/Postal Code
25198
Country
Spain
Facility Name
Hospital 12 de Octobre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
HCU Virgen de la Victoria
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Clinica Universitaria de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Mutua de Terrassa
City
Terrassa (Barcelona)
ZIP/Postal Code
08221
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Lanssjukhuset Ryhov
City
Jönköping
ZIP/Postal Code
55185
Country
Sweden
Facility Name
Norrlands Universitetssjukhus
City
Umeå
ZIP/Postal Code
90185
Country
Sweden
Facility Name
Centrallasarettet Vasteras
City
Västerås
ZIP/Postal Code
721 89
Country
Sweden
Facility Name
Clatterbridge Centre for Oncology NHS Trust
City
Bebington, Wirral
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Facility Name
Addenbrookes Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Royal Surrey County Hospital
City
Guildford
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Facility Name
Guy's and St Thomas' Hospital - London
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
St George's Hospital
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Christie NHS Trust Hospital
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Nottingham City Hospital
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Northern Lincolnshire and Goole Hospitals NHS Foundation Trust
City
Scunthorpe
ZIP/Postal Code
DN15 7BH
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
27522164
Citation
Vogelzang NJ, Fizazi K, Burke JM, De Wit R, Bellmunt J, Hutson TE, Crane E, Berry WR, Doner K, Hainsworth JD, Wiechno PJ, Liu K, Waldman MF, Gandhi A, Barton D, Jungnelius U, Fandi A, Sternberg CN, Petrylak DP. Circulating Tumor Cells in a Phase 3 Study of Docetaxel and Prednisone with or without Lenalidomide in Metastatic Castration-resistant Prostate Cancer. Eur Urol. 2017 Feb;71(2):168-171. doi: 10.1016/j.eururo.2016.07.051. Epub 2016 Aug 10.
Results Reference
background
PubMed Identifier
25743937
Citation
Petrylak DP, Vogelzang NJ, Budnik N, Wiechno PJ, Sternberg CN, Doner K, Bellmunt J, Burke JM, de Olza MO, Choudhury A, Gschwend JE, Kopyltsov E, Flechon A, Van As N, Houede N, Barton D, Fandi A, Jungnelius U, Li S, de Wit R, Fizazi K. Docetaxel and prednisone with or without lenalidomide in chemotherapy-naive patients with metastatic castration-resistant prostate cancer (MAINSAIL): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet Oncol. 2015 Apr;16(4):417-25. doi: 10.1016/S1470-2045(15)70025-2. Epub 2015 Mar 3.
Results Reference
result
PubMed Identifier
27560549
Citation
de Morree ES, Vogelzang NJ, Petrylak DP, Budnik N, Wiechno PJ, Sternberg CN, Doner K, Bellmunt J, Burke JM, Ochoa de Olza M, Choudhury A, Gschwend JE, Kopyltsov E, Flechon A, van As N, Houede N, Barton D, Fandi A, Jungnelius U, Li S, Li JS, de Wit R. Association of Survival Benefit With Docetaxel in Prostate Cancer and Total Number of Cycles Administered: A Post Hoc Analysis of the Mainsail Study. JAMA Oncol. 2017 Jan 1;3(1):68-75. doi: 10.1001/jamaoncol.2016.3000.
Results Reference
result
Learn more about this trial
Study to Evaluate Safety and Effectiveness of Lenalidomide in Combination With Docetaxel and Prednisone for Patients With Castrate-Resistant Prostate Cancer
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