Clinical trial NCT00988208: Study to Evaluate Safety and Effectiveness of Lenalidomide in Combination With Docetaxel and Prednisone for Patients With Castrate-Resistant Prostate Cancer
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: Castrate-Resistant Prostate Cancer
Revlimid
Lenalidomide
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2009-10-02
Enrollment: 1059
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Must sign an Informed Consent Form (ICF)
2. Males ≥ 18 years of age
3. Able to adhere to the study visit schedule and requirements of the protocol
4. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
5. Life expectancy of ≥ 12 weeks
6. Willingness to participate in Patient-Reported Outcomes assessments
7. Serum testosterone levels \< 50 ng/dL
8. Confirmed metastatic adenocarcinoma of the prostate that is unresponsive or refractory to hormonal therapy
9. 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
10. Subjects must agree to receive counseling related to pregnancy precautions, teratogenic and other risks of lenalidomide
11. Refrain from donating blood or semen as defined by protocol

Exclusion Criteria:

1. A history of clinically significant disease that places subject at an unacceptable risk for study entry
2. Prior Therapy with thalidomide, lenalidomide or pomalidomide
3. Prior chemotherapy for prostate cancer
4. Use of any other experimental drug or therapy within 28 days prior to randomization
5. Prior radiation to ≥ 30% of bone marrow or any radiation therapy within 28 days prior to randomization
6. Prior use of Strontium-89 at any time or Samarium-153 within 56 days prior to randomization
7. Surgery within 28 days prior to randomization
8. Concurrent anti-androgen therapy
9. Abnormal serum chemistry or hematology laboratory values
10. Significant active cardiac disease within the previous 6 months:
11. Thrombotic or thromboembolic events within the past 6 months:
12. History of peripheral neuropathy of ≥grade 2
13. History of severe hypersensitivity reaction to drugs formulated with polysorbate 80
14. Paraplegia
15. History of Central nervous system (CNS) or brain metastases
16. 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
17. Concurrent use of alternative cancer therapies

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: From randomization until death from any cause up to the cut-off date of 13 January 2012; up to approximately 26 months
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: 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
measure: Percentage of Participants With an Objective Response According to Response Evaluation Criteria in Solid Tumors - RECIST Version 1.1 Criteria
timeFrame: From day 1 to data cut-off 13 January 2012; maximum time on study was approximately 26 months
measure: Number of Participants With Treatment Emergent Adverse Events (AEs)
timeFrame: 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
measure: Percentage of Participants Who Received Post-Study Therapies
timeFrame: 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
measure: Percentage of Participants With Secondary Primary Malignancies During the Course of the Trial
timeFrame: 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
measure: Time to Onset of Secondary Primary Malignancies
timeFrame: 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
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Hematology Oncology Associates
state: Arizona
city: Sedona
country: United States
facility: Northern AZ Hematology and Oncology Assoc
state: Arizona
city: Tucson
country: United States
facility: Arizona Oncology
state: Arizona
city: Duarte
country: United States
facility: City of Hope Cancer Center
state: California
city: Escondido
country: United States
facility: Southwest Cancer Center - Escondido
state: California
city: La Jolla
country: United States
facility: Scripps Cancer Center - Clinical Research
state: California
city: Long Beach
country: United States
facility: VA Long Beach Healthcare System
state: California
city: Los Angeles
country: United States
facility: The Angeles Clinc and Research Institute
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Marina Del Rey
country: United States
facility: Prostate Oncology Specialists
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Colorado Springs
country: United States
facility: Rocky Mountain Cancer Centers-Colorado Springs Circle
state: Colorado
city: Washington
country: United States
facility: Washington Cancer Institute
state: District of Columbia
city: Melbourne
country: United States
facility: Melbourne Internal Medicine Associates
state: Florida
city: Miami
country: United States
facility: Advanced Medical Specialties
state: Florida
city: New Port Richey
country: United States
facility: Florida Cancer Institute - New Hope
state: Florida
city: Ocala
country: United States
facility: Ocala Oncology Center
state: Florida
city: Orlando
country: United States
facility: Cancer Centers of Florida, P.A.- West Gore Street
state: Florida
city: Tamarac
country: United States
facility: South Florida Oncology - Hematology
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Cancer Institute, LLC
state: Florida
city: Niles
country: United States
facility: Cancer Care and Hematology Specialists of Chicagoland
state: Illinois
city: Park Ridge
country: United States
facility: Lutheran General Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Health
state: Indiana
city: Metairie
country: United States
facility: Hematology and Oncology Specialist, LLC
state: Louisiana
city: Columbia
country: United States
facility: Maryland Oncology Hematology PA
state: Maryland
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology, PA
state: Minnesota
city: Columbia
country: United States
facility: Missouri Cancer Associates
state: Missouri
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Berkeley Heights
country: United States
facility: Summit Medical Group Overlook Oncology Center
state: New Jersey
city: Morristown
country: United States
facility: Hematology-Oncology Associates of NNJ, P
state: New Jersey
city: Mount Holly
country: United States
facility: Hematology Oncology Associates of South Jersey
state: New Jersey
city: Albany
country: United States
facility: New York Oncology Hematology P.C.
state: New York
city: New York
country: United States
facility: Columbia Univ Medical Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College Dr. Feldman's Office
state: New York
city: New Bern
country: United States
facility: New Bern Cancer Care
state: North Carolina
city: Raleigh
country: United States
facility: Cancer Centers of North Carolina
state: North Carolina
city: Bismarck
country: United States
facility: Mid Dakota Clinic, PC
state: North Dakota
city: Cincinnati
country: United States
facility: Oncology Hematology Care, Inc.
state: Ohio
city: Tualatin
country: United States
facility: Northwest Cancer Specialists-Tualatin
state: Oregon
city: Charleston
country: United States
facility: Ralph H. Johnson VA Medical Center
state: South Carolina
city: Columbia
country: United States
facility: South Carolina Oncology Associates, PA
state: South Carolina
city: Greer
country: United States
facility: Cancer Center of the Carolinas
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga Oncology Hematology Associates
state: Tennessee
city: Cookeville
country: United States
facility: Cookeville Regional Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Research Institute UK
state: Tennessee
city: Amarillo
country: United States
facility: Texas Oncology, P.A.-Amarillo
state: Texas
city: Arlington
country: United States
facility: Texas Oncology-Arlington South
state: Texas
city: Austin
country: United States
facility: Texas Oncology, PA
state: Texas
city: Dallas
country: United States
facility: Baylor Sammons Cancer Center
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology, P.A.-Fort Worth
state: Texas
city: Longview
country: United States
facility: Longview Cancer Center
state: Texas
city: Midland
country: United States
facility: Allison Cancer Center
state: Texas
city: Paris
country: United States
facility: Texas Oncology, P.A. - Paris
state: Texas
city: Southlake
country: United States
facility: Southlake Oncology
state: Texas
city: Tyler
country: United States
facility: Texas Oncology, P.A. - Tyler
state: Texas
city: Webster
country: United States
facility: Texas Oncology Deke Slayton Cancer Center
state: Texas
city: Wichita Falls
country: United States
facility: Texas Oncology-Texoma Cancer Center
state: Texas
city: White River Junction
country: United States
facility: Veterans Education and Research Association of Northern New England, Inc.
state: Vermont
city: Abingdon
country: United States
facility: Cancer Outreach Associates
state: Virginia
city: Fairfax
country: United States
facility: Fairfax Northern Virginia Hematology Oncology
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Richmond
country: United States
facility: Virginia Cancer Institute
state: Virginia
city: Roanoke
country: United States
facility: Oncology and Hematology Associates of Southwest Virginia, Inc.
state: Virginia
city: Kennewick
country: United States
facility: Columbia Basin Hematology and Oncology
state: Washington
city: Seattle
country: United States
facility: VA Puget Sound HCS Seattle Division
state: Washington
city: Spokane
country: United States
facility: Evergreen Hematology and Oncology
state: Washington
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
city: Port Macquarie
country: Australia
facility: Port Macquarie Base Hospital
city: Redcliffe
country: Australia
facility: Redcliffe Hospital
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
city: Waratah
country: Australia
facility: Newcastle Calvary Mater Hospital
city: Westmead
country: Australia
facility: Westmead Hospital
city: Wodonga
country: Australia
facility: Border Medical Oncology
city: Woodville South
country: Australia
facility: The Queen Elizabeth Hospital
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
city: Graz
country: Austria
facility: Medical University of Graz
city: Salzburg
country: Austria
facility: Landeskrankenhaus Salzburg
city: Vienna
country: Austria
facility: Krankenhaus der Barmherzigen Brueder
city: Vienna
country: Austria
facility: Medizinische Universitat Wien
city: Antwerpen
country: Belgium
facility: ZNA Middelheim
city: Brussels
country: Belgium
facility: Hopital Erasme
city: Bruxelles
country: Belgium
facility: Edith Cavell Clinic
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Leuven
country: Belgium
facility: UZ Leuven
city: Sint-Niklaas
country: Belgium
facility: AZ Nikolaas
city: Toronto
country: Canada
facility: The Health Institute for Men CMX Research Inc
state: Ontario
city: Montreal
country: Canada
facility: Les Urologues Specialises
state: Quebec
city: Chomutov
country: Czechia
facility: Krajska zdravotni, a.s. Nemocnice Chomutov, o.z.
city: Prague 5
country: Czechia
facility: Fakultni nemocnice Motol
city: Usti Nad Labem
country: Czechia
facility: Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad La
city: Aarhus C
country: Denmark
facility: Arhus Universitets hospital
city: Herlev
country: Denmark
facility: Herlev Hospital
city: Kobenhavn
country: Denmark
facility: Rigshospitalet University Hospital
city: Odense C
country: Denmark
facility: Odense Universitetshospital
city: Angers 49
country: France
facility: CRLCC Paul Papin
city: Bordeaux
country: France
facility: Institut Bergonie Centre Regional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest
city: Dijon Cedex
country: France
facility: Centre Georges Francois Leclerc
city: Le Mans
country: France
facility: Clinique Victor Hugo
city: Lille 59
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Centre Leon Berard
city: Nimes
country: France
facility: Clinique de Valdegour
city: Poitiers Cedex
country: France
facility: CHU de Poitiers
city: Rennes Cedex
country: France
facility: Centre Eugene Marquis
city: Saint Herblain 44
country: France
facility: CRLCC Centre Rene Gauducheau
city: Saint Priest En Jaroz
country: France
facility: Institut de Cancerologie de la Loire
city: Strasbourg
country: France
facility: Hopital Civil de Strasbourg
city: Tours Cedex
country: France
facility: CHRU Hopital Bretonneau
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Berlin
country: Germany
facility: Vivantes Klinikum am Urban
city: Bonn
country: Germany
facility: Medizinisches Zentrum Bonn-Friedensplatz
city: Dessau-Rosslau
country: Germany
facility: Diakonissenkrankenhaus Dessau gGmbH
city: Duesseldorf
country: Germany
facility: Universitaetsklinikum Duesseldorf
city: Frankfurt a.M.
country: Germany
facility: Krankenhaus Nordwest
city: Freiburg
country: Germany
facility: Onkologische Praxis Freiburg
city: Hamburg
country: Germany
facility: Universitatsklinikum Hamburg-Eppendorf / IVDP
city: Hamburg
country: Germany
facility: IORC- Innovation Onkologie Research and Consulting GmbH
city: Koblenz
country: Germany
facility: Praxis fuer Haematologie und Onkologie Koblenz
city: Leipzig
country: Germany
facility: Vituro GmbH & Co KG
city: München
country: Germany
facility: TU München - Klinikum rechts der Isar
city: Münster
country: Germany
facility: Universitaetsklinikum Muenster
city: Tuebingen
country: Germany
facility: University-Hospital Tübingen
city: Ulm
country: Germany
facility: Universitatsklinikum Ulm
city: Athens
country: Greece
facility: Alexandra General Hospital of Athens
city: Athens
country: Greece
facility: Agioi Anargyroi Hospital
city: Larissa
country: Greece
facility: University Hospital of Larissa
city: Thessaloniki
country: Greece
facility: Papageorgiou General Hospital of Thessaloniki
city: Budapest
country: Hungary
facility: Fovarosi Onkirmanyzat Peterfy S.Utcai Korhaz-Rend.Int es Baleseti Kozp.
city: Budapest
country: Hungary
facility: Fovarosi Onkormanyzat Bajcsy-Zsilinszky Korhaz es Rendelointezet
city: Miskolc
country: Hungary
facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegytem Altalanos Orvostudomanyi Kar
city: Beer Sheva
country: Israel
facility: The Soroka University Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
city: Zerifin
country: Israel
facility: Assaf Harofeh Medical Center
city: Bari
country: Italy
facility: Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
city: Candiolo
country: Italy
facility: Ordine Mauriziano
city: Cremona
country: Italy
facility: Azienda Ospedaliera Istituti Ospitalieri di Cremona
city: Lecce
country: Italy
facility: Ospedale Vito Fazzi
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.)
city: Mirano (VE)
country: Italy
facility: Ospedale di Mirano
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Rimini
country: Italy
facility: Ospedale degli Infermi di Rimini
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini
city: Udine
country: Italy
facility: Azienda Ospedaliero-Universitaria Santa Maria della Miserico
city: D.f, Df
country: Mexico
facility: Hospital Angeles Lindavista
city: Durango, DGO
country: Mexico
facility: Consultorio de Especialidad en Urologia Privado
city: Sinaloa, SIN
country: Mexico
facility: Hospital Fatima
city: Zapopan, JAL
country: Mexico
facility: Consultorio Privado- Dr Jose Arturo Rodriguez Rivera
city: Amsterdam
country: Netherlands
facility: VU University Medical Center VU Medisch Centrum
city: Arhem
country: Netherlands
facility: Ziekenhuis Rijnstate
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis Molengracht
city: Den Haag
country: Netherlands
facility: HagaZiekenhuis
city: Den Helder
country: Netherlands
facility: Gemini Ziekenhuis
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis Amstelwijck
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum
city: Maastricht
country: Netherlands
facility: Academisch Ziekenhuis Maastricht
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis Nieuwegein
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
city: Tilburg
country: Netherlands
facility: Twee Steden Ziekenhuis Tilburg
city: Venlo
country: Netherlands
facility: VieCuri Medisch Centrum Venlo
city: Zwolle
country: Netherlands
facility: Isala Klinieken
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Lodz
country: Poland
facility: Regionalny Osrodek Onkologiczny WSS im. M. Kopernika
city: Olsztyn
country: Poland
facility: ZOZ MSWiA z Warminsko- Mazurskim Centrum Onkologii
city: Olsztyn
country: Poland
facility: NZOZ Olsztynski Osr. Onkologiczny Kopernik Sp.z o.o
city: Rybnik
country: Poland
facility: SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 w Rybniku
city: Warszawa
country: Poland
facility: Centrum Onkologii-Instytut im.Marii Sklodowskiej-Curie
city: Wroclaw
country: Poland
facility: 4 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ
city: Moscow
country: Russian Federation
facility: Moscow Oncology Clinical Dispensary 1
city: Obninsk
country: Russian Federation
facility: Medical Radiology Research Centre RAMS
city: Omsk
country: Russian Federation
facility: State Institution of Heath Omsk Regional Oncology Dispensary
city: Pesochny Vlg Saint Petersburg
country: Russian Federation
facility: Russian Scientific Center for Radiology and Surgical Technol, St. Petersburg
city: Rostov-on-Don
country: Russian Federation
facility: NSHI Dorozhnaya Clinical Hospital of OAO Russian Railways
city: Sochi
country: Russian Federation
facility: Oncology Dispensary 2 of Krasnodar Region
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl Regional Clinical Oncology Hospital
city: Cape Town, W Cape
country: South Africa
facility: Groote Schuur Hospital
city: Durban, KZ-Natal
country: South Africa
facility: The Oncology Centre Durban
city: Durban, KZ-Natal
country: South Africa
facility: Westridge Medical Centre
city: Goodwood, W Cape
country: South Africa
facility: Netcare Oncology and Interventional Centre
city: Polokwane
country: South Africa
facility: Dr. H. Malan
city: Pretoria
country: South Africa
facility: Pretoria Urology Hospital
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Hospitalet de Llobregat, Barcelona
country: Spain
facility: Hospital Durán i Reynals - Instituto Catalàn de Oncologìa ICO
city: Lérida
country: Spain
facility: Hospital Arnau de Vilanova
city: Madrid
country: Spain
facility: Hospital 12 de Octobre
city: Malaga
country: Spain
facility: HCU Virgen de la Victoria
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra
city: Terrassa (Barcelona)
country: Spain
facility: Hospital Mutua de Terrassa
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Jönköping
country: Sweden
facility: Lanssjukhuset Ryhov
city: Umeå
country: Sweden
facility: Norrlands Universitetssjukhus
city: Västerås
country: Sweden
facility: Centrallasarettet Vasteras
city: Bebington, Wirral
country: United Kingdom
facility: Clatterbridge Centre for Oncology NHS Trust
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital
city: London
country: United Kingdom
facility: Guy's and St Thomas' Hospital - London
city: London
country: United Kingdom
facility: St George's Hospital
city: London
country: United Kingdom
facility: Royal Marsden Hospital
city: Manchester
country: United Kingdom
facility: Christie NHS Trust Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital
city: Scunthorpe
country: United Kingdom
facility: Northern Lincolnshire and Goole Hospitals NHS Foundation Trust
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital
Study officials:
affiliation: Celgene Corporation
name: Debora Barton, MD
role: STUDY_DIRECTOR
References:
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.
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.
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.