AzTrials
AzTrials

Prostate CancerPhase 3MainsailNCT00988208

Study to Evaluate Safety and Effectiveness of Lenalidomide in Combination With Docetaxel and Prednisone for Patients With Castrate-Resistant Prostate Cancer

A Phase 3 study testing Lenalidomide, Docetaxel and Prednisone in people with Prostate Cancer, run by Celgene at 210 sites in 21 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Lenalidomide, Docetaxel and Prednisone
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,059 participants
Where
210 sitesin 21 countries
Study dates
11 Nov 2009to 28 Nov 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

210 sites in 21 countries.

210 sites in 21 countries

United States66 sites

  • Cancer Outreach Associates

    Abingdon, Virginia, 24211

  • New York Oncology Hematology P.C.

    Albany, New York, 12208

  • Texas Oncology, P.A.-Amarillo

    Amarillo, Texas, 79106

  • Texas Oncology-Arlington South

    Arlington, Texas, 76014

  • Texas Oncology, PA

    Austin, Texas, 78758

  • Summit Medical Group Overlook Oncology Center

    Berkeley Heights, New Jersey, 07922

  • Mid Dakota Clinic, PC

    Bismarck, North Dakota, 58501

  • Ralph H. Johnson VA Medical Center

    Charleston, South Carolina, 29401

  • Chattanooga Oncology Hematology Associates

    Chattanooga, Tennessee, 37404

  • Oncology Hematology Care, Inc.

    Cincinnati, Ohio, 45242

  • Rocky Mountain Cancer Centers-Colorado Springs Circle

    Colorado Springs, Colorado, 80909

  • Maryland Oncology Hematology PA

    Columbia, Maryland, 21044

  • Missouri Cancer Associates

    Columbia, Missouri, 65201

  • South Carolina Oncology Associates, PA

    Columbia, South Carolina, 29210

  • Cookeville Regional Medical Center

    Cookeville, Tennessee, 38501

  • Baylor Sammons Cancer Center

    Dallas, Texas, 75246

  • City of Hope Cancer Center

    Duarte, California, 91010-3000

  • Southwest Cancer Center - Escondido

    Escondido, California, 92025

  • Fairfax Northern Virginia Hematology Oncology

    Fairfax, Virginia, 22031

  • Texas Oncology, P.A.-Fort Worth

    Fort Worth, Texas, 76104

  • Cancer Center of the Carolinas

    Greer, South Carolina, 29650

  • Indiana University Health

    Indianapolis, Indiana, 46219

  • Columbia Basin Hematology and Oncology

    Kennewick, Washington, 99336

  • Scripps Cancer Center - Clinical Research

    La Jolla, California, 92037

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

  • VA Long Beach Healthcare System

    Long Beach, California, 90822

  • Longview Cancer Center

    Longview, Texas, 75601

  • The Angeles Clinc and Research Institute

    Los Angeles, California, 90025

  • University of Southern California

    Los Angeles, California, 90033

  • Prostate Oncology Specialists

    Marina del Rey, California, 90292

  • Melbourne Internal Medicine Associates

    Melbourne, Florida, 32901

  • Hematology and Oncology Specialist, LLC

    Metairie, Louisiana, 70006

  • Advanced Medical Specialties

    Miami, Florida, 33176

  • Allison Cancer Center

    Midland, Texas, 79701

  • Minnesota Oncology Hematology, PA

    Minneapolis, Minnesota, 55404

  • Hematology-Oncology Associates of NNJ, P

    Morristown, New Jersey, 07960

  • Hematology Oncology Associates of South Jersey

    Mount Holly, New Jersey, 08060

  • Sarah Cannon Research Institute UK

    Nashville, Tennessee, 37203-1632

  • New Bern Cancer Care

    New Bern, North Carolina, 28562

  • Florida Cancer Institute - New Hope

    New Port Richey, Florida, 34655

  • Columbia Univ Medical Center

    New York, New York, 10032

  • Weill Cornell Medical College Dr. Feldman's Office

    New York, New York, 10065

  • Cancer Care and Hematology Specialists of Chicagoland

    Niles, Illinois, 60714

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Ocala Oncology Center

    Ocala, Florida, 34474

  • Cancer Centers of Florida, P.A.- West Gore Street

    Orlando, Florida, 32806

  • Texas Oncology, P.A. - Paris

    Paris, Texas, 75460

  • Lutheran General Hospital

    Park Ridge, Illinois, 60068

  • Hematology Oncology Associates

    Phoenix, Arizona, 85012

  • Cancer Centers of North Carolina

    Raleigh, North Carolina, 27607

  • Virginia Cancer Institute

    Richmond, Virginia, 23230

  • Oncology and Hematology Associates of Southwest Virginia, Inc.

    Roanoke, Virginia, 24014

  • VA Puget Sound HCS Seattle Division

    Seattle, Washington, 98108-1532

  • Northern AZ Hematology and Oncology Assoc

    Sedona, Arizona, 86336

  • Southlake Oncology

    Southlake, Texas, 76092

  • Evergreen Hematology and Oncology

    Spokane, Washington, 99218

  • Stanford University Medical Center

    Stanford, California, 94035-5821

  • South Florida Oncology - Hematology

    Tamarac, Florida, 33321

  • Northwest Cancer Specialists-Tualatin

    Tualatin, Oregon, 97062

  • Arizona Oncology

    Tucson, Arizona, 85710

  • Texas Oncology, P.A. - Tyler

    Tyler, Texas, 75702

  • Washington Cancer Institute

    Washington D.C., District of Columbia, 20010

  • Texas Oncology Deke Slayton Cancer Center

    Webster, Texas, 77598

  • Palm Beach Cancer Institute, LLC

    West Palm Beach, Florida, 33401

  • Veterans Education and Research Association of Northern New England, Inc.

    White River Junction, Vermont, 05009

  • Texas Oncology-Texoma Cancer Center

    Wichita Falls, Texas, 76310

Other trials in United States

Netherlands16 sites

  • VU University Medical Center VU Medisch Centrum

    Amsterdam, 1081 HV

  • Ziekenhuis Rijnstate

    Arhem, 6800 TA

  • Amphia Ziekenhuis Molengracht

    Breda, 4818 CK

  • Gemini Ziekenhuis

    Den Helder, 1782 GZ

  • Albert Schweitzer Ziekenhuis Amstelwijck

    Dordrecht, 3317 NM

  • Catharina Ziekenhuis

    Eindhoven, 5632 EJ

  • Medisch Centrum Leeuwarden

    Leeuwarden, 8934 AD

  • Leids Universitair Medisch Centrum

    Leiden, 2333 ZA

  • Academisch Ziekenhuis Maastricht

    Maastricht, 6229 HX

  • St. Antonius Ziekenhuis Nieuwegein

    Nieuwegein, 3435 CM

  • Erasmus Medical Center

    Rotterdam, 3015 GD

  • Erasmus Medisch Centrum

    Rotterdam, 3015 GD

  • HagaZiekenhuis

    The Hague, 2545 CH

  • Twee Steden Ziekenhuis Tilburg

    Tilburg, 5042 AD

  • VieCuri Medisch Centrum Venlo

    Venlo, 5912 BL

  • Isala Klinieken

    Zwolle, 8025 AB

Other trials in Netherlands

France14 sites

  • CRLCC Paul Papin

    Angers, 49933

  • Institut Bergonie Centre Regional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest

    Bordeaux, 33076

  • Centre Georges Francois Leclerc

    Dijon, 21079

  • Clinique Victor Hugo

    Le Mans, 72000

  • Centre Oscar Lambret

    Lille, 59020

  • Centre Leon Berard

    Lyon, 69373

  • Clinique de Valdegour

    Nîmes, 30900

  • CHU de Poitiers

    Poitiers, 86021

  • Centre Eugene Marquis

    Rennes, 35042

  • Institut de Cancerologie de la Loire

    Saint Priest En Jaroz, 42270

  • CRLCC Centre Rene Gauducheau

    Saint-Herblain, 44805

  • Hopital Civil de Strasbourg

    Strasbourg, 67091

  • CHRU Hopital Bretonneau

    Tours, 37044

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Germany14 sites

  • Vivantes Klinikum am Urban

    Berlin, 10967

  • Medizinisches Zentrum Bonn-Friedensplatz

    Bonn, 53111

  • Diakonissenkrankenhaus Dessau gGmbH

    Dessau, 06846

  • Universitaetsklinikum Duesseldorf

    Düsseldorf, 40225

  • Krankenhaus Nordwest

    Frankfurt a.M., 60488

  • Onkologische Praxis Freiburg

    Freiburg im Breisgau, 79106

  • Universitatsklinikum Hamburg-Eppendorf / IVDP

    Hamburg, 20246

  • IORC- Innovation Onkologie Research and Consulting GmbH

    Hamburg, 22081

  • Praxis fuer Haematologie und Onkologie Koblenz

    Koblenz, 56068

  • Vituro GmbH & Co KG

    Leipzig, 4277

  • TU München - Klinikum rechts der Isar

    München, 81675

  • Universitaetsklinikum Muenster

    Münster, 48149

  • University-Hospital Tübingen

    Tübingen, 72076

  • Universitatsklinikum Ulm

    Ulm, 89075

Other trials in Germany

Australia13 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, SA 5000

  • Flinders Medical Centre

    Bedford Park, 5042

  • Chris O'Brien Lifehouse

    Camperdown, NSW 2050

  • Sir Charles Gairdner Hospital

    Nedlands, 6009

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Port Macquarie Base Hospital

    Port Macquarie, NSW 2444

  • Redcliffe Hospital

    Redcliffe, QLD 4020

  • Royal North Shore Hospital

    St Leonards, 2065

  • Newcastle Calvary Mater Hospital

    Waratah, 2298

  • Westmead Hospital

    Westmead, NSW 2145

  • Border Medical Oncology

    Wodonga, 3690

  • The Queen Elizabeth Hospital

    Woodville South, 5011

  • Princess Alexandra Hospital

    Woolloongabba, QLD 4102

Other trials in Australia

Italy10 sites

  • Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

    Bari, 70124

  • Ordine Mauriziano

    Candiolo, 10023

  • Azienda Ospedaliera Istituti Ospitalieri di Cremona

    Cremona, 23100

  • Ospedale Vito Fazzi

    Lecce, 73100

  • Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.)

    Meldola, 47014

  • Ospedale di Mirano

    Mirano (VE), 30035

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126

  • Ospedale degli Infermi di Rimini

    Rimini, 47900

  • Azienda Ospedaliera San Camillo Forlanini

    Roma, 00149

  • Azienda Ospedaliero-Universitaria Santa Maria della Miserico

    Udine, 70124

Other trials in Italy

United Kingdom10 sites

  • Clatterbridge Centre for Oncology NHS Trust

    Bebington, Wirral, CH63 4JY

  • Addenbrookes Hospital

    Cambridge, CB2 0QQ

  • Royal Surrey County Hospital

    Guildford, GU2 7XX

  • Guy's and St Thomas' Hospital - London

    London, SE1 9RT

  • St George's Hospital

    London, SW17 0QT

  • Royal Marsden Hospital

    London, SW3 6JJ

  • Christie NHS Trust Hospital

    Manchester, M20 4BX

  • Nottingham City Hospital

    Nottingham, NG5 1PB

  • Northern Lincolnshire and Goole Hospitals NHS Foundation Trust

    Scunthorpe, DN15 7BH

  • Royal Marsden Hospital

    Sutton, SM2 5PT

Other trials in United Kingdom

Spain9 sites

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Durán i Reynals - Instituto Catalàn de Oncologìa ICO

    Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Arnau de Vilanova

    Lleida, 25198

  • Hospital 12 de Octobre

    Madrid, 28041

  • HCU Virgen de la Victoria

    Málaga, 29010

  • Clinica Universitaria de Navarra

    Pamplona, 31008

  • Hospital Mutua de Terrassa

    Terrassa (Barcelona), 08221

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Poland7 sites

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952

  • Regionalny Osrodek Onkologiczny WSS im. M. Kopernika

    Lodz, 93-509

  • ZOZ MSWiA z Warminsko- Mazurskim Centrum Onkologii

    Olsztyn, 10-228

  • NZOZ Olsztynski Osr. Onkologiczny Kopernik Sp.z o.o

    Olsztyn, 10-513

  • SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 w Rybniku

    Rybnik, 44-200

  • Centrum Onkologii-Instytut im.Marii Sklodowskiej-Curie

    Warsaw, 02-781

  • 4 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ

    Wroclaw, 50-981

Other trials in Poland

Russia7 sites

  • Moscow Oncology Clinical Dispensary 1

    Moscow, 105005

  • Medical Radiology Research Centre RAMS

    Obninsk, 249036

  • State Institution of Heath Omsk Regional Oncology Dispensary

    Omsk, 644013

  • Russian Scientific Center for Radiology and Surgical Technol, St. Petersburg

    Pesochny Vlg Saint Petersburg, 197758

  • NSHI Dorozhnaya Clinical Hospital of OAO Russian Railways

    Rostov-on-Don, 344011

  • Oncology Dispensary 2 of Krasnodar Region

    Sochi, 354057

  • Yaroslavl Regional Clinical Oncology Hospital

    Yaroslavl, 150054

Other trials in Russia

Belgium6 sites

  • ZNA Middelheim

    Antwerp, 2020

  • Hopital Erasme

    Brussels, 1070

  • Edith Cavell Clinic

    Brussels, 1180

  • AZ Groeninge

    Kortrijk, 8500

  • UZ Leuven

    Leuven, 3000

  • AZ Nikolaas

    Sint-Niklaas, 9100

Other trials in Belgium

South Africa6 sites

  • Groote Schuur Hospital

    Cape Town, W Cape, 7925

  • The Oncology Centre Durban

    Durban, KZ-Natal, 4091

  • Westridge Medical Centre

    Durban, KZ-Natal, 4091

  • Netcare Oncology and Interventional Centre

    Goodwood, W Cape, 7460

  • Dr. H. Malan

    Polokwane, 699

  • Pretoria Urology Hospital

    Pretoria, 0083

Other trials in South Africa

Austria4 sites

  • Medical University of Graz

    Graz, 8036

  • Landeskrankenhaus Salzburg

    Salzburg, 5020

  • Krankenhaus der Barmherzigen Brueder

    Vienna, 1020

  • Medizinische Universitat Wien

    Vienna, 1090

Other trials in Austria

Denmark4 sites

  • Arhus Universitets hospital

    Aarhus C, 8000

  • Rigshospitalet University Hospital

    Copenhagen, 2100

  • Herlev Hospital

    Herlev, 2730

  • Odense Universitetshospital

    Odense C, 5000

Other trials in Denmark

Greece4 sites

  • Alexandra General Hospital of Athens

    Athens, 11528

  • Agioi Anargyroi Hospital

    Athens, 14564

  • University Hospital of Larissa

    Larissa, 41110

  • Papageorgiou General Hospital of Thessaloniki

    Thessaloniki, 56429

Other trials in Greece

Hungary4 sites

  • Fovarosi Onkirmanyzat Peterfy S.Utcai Korhaz-Rend.Int es Baleseti Kozp.

    Budapest, 1076

  • Fovarosi Onkormanyzat Bajcsy-Zsilinszky Korhaz es Rendelointezet

    Budapest, 1106

  • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

    Miskolc, 3526

  • Pecsi Tudomanyegytem Altalanos Orvostudomanyi Kar

    Pécs, 7623

Other trials in Hungary

Israel4 sites

  • The Soroka University Medical Center

    Beersheba, 84101

  • Rambam Health Care Campus

    Haifa, 31096

  • Rabin Medical Center

    Petah Tikva, 49100

  • Assaf Harofeh Medical Center

    Tsrifin, 70300

Other trials in Israel

Mexico4 sites

  • Hospital Angeles Lindavista

    D.F, DF, 07760

  • Consultorio de Especialidad en Urologia Privado

    Durango, DGO, 34000

  • Hospital Fatima

    Sinaloa, SIN, 81200

  • Consultorio Privado- Dr Jose Arturo Rodriguez Rivera

    Zapopan, JAL, 45040

Other trials in Mexico

Czechia3 sites

  • Krajska zdravotni, a.s. Nemocnice Chomutov, o.z.

    Chomutov, 430 12

  • Fakultni nemocnice Motol

    Prague, 150 06

  • Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad La

    Ústí nad Labem, 40113

Other trials in Czechia

Sweden3 sites

  • Lanssjukhuset Ryhov

    Jönköping, 55185

  • Norrlands Universitetssjukhus

    Umeå, 90185

  • Centrallasarettet Vasteras

    Västerås, 721 89

Other trials in Sweden

Canada2 sites

  • Les Urologues Specialises

    Montreal, Quebec, H2X 1N8

  • The Health Institute for Men CMX Research Inc

    Toronto, Ontario, M1P 2T7

Other trials in Canada

About this study

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)

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.

Read the 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.

Conditions
Prostate Cancer
Being tested
Lenalidomide, Docetaxel, Prednisone, Placebo
Keywords
Castrate-Resistant Prostate Cancer, Revlimid, Lenalidomide
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LenalidomideDrug

    Also called CC-5013, Revlimid

    25 mg lenalidomide orally once each day on Days 1-14

  • DocetaxelDrug

    Also called Taxotere

    75 mg/m2 intravenous docetaxel on Day 1

  • PrednisoneDrug

    Also called There are multiple brand names for prednisone.

    5 mg prednisone orally twice daily on each day of the treatment cycle

  • PlaceboDrug

    Oral placebo once each day on Days 1-14 of the treatment cycle

Study groups in NCT00988208
Study groupRoleWhat they receive
Docetaxel, Prednisone, Lenalidomide (DPL)Experimental25 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
Receives: Drug: Lenalidomide; Drug: Docetaxel; Drug: Prednisone
Docetaxel and Prednisone (DP)ExperimentalOral 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
Receives: Drug: Docetaxel; Drug: Prednisone; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From randomization until death from any cause up to the cut-off date of 13 January 2012; up to approximately 26 months

Secondary outcomes (6)

  1. 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

    Measured: 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

  2. 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

    Measured: From day 1 to data cut-off 13 January 2012; maximum time on study was approximately 26 months

  3. 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;

    Measured: 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

  4. Percentage of Participants Who Received Post-Study Therapies

    Percentage of Participants Who Received Post-Study Therapies for advanced Prostate Cancer.

    Measured: 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

  5. 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.

    Measured: 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

  6. Time to Onset of Secondary Primary Malignancies

    Time of Onset of Secondary Primary Malignancies was considered an event of interest

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2009 (estimated)
  2. Study start11 Nov 2009
  3. Primary completion13 Jan 2012
  4. Study completion28 Nov 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,059 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00988208
Sponsor's protocol ID
CC-5013-PC-002
Other IDs
EudraCT Number 2008-007969-23
Acronym
Mainsail
Status last verified
Mar 2018
First submitted
1 Oct 2009
Last updated
4 Apr 2018
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 27522164

  • 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.

    PubMed 25743937

  • 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.

    PubMed 27560549

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lenalidomide, Docetaxel and Prednisone in people with Prostate Cancer, run by Celgene at 210 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 210 sites in United States, Netherlands, France, Germany, Australia and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: From randomization until death from any cause up to the cut-off date of 13 January 2012; up to approximately 26 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00988208, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2018.

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