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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00988208




Registration number
NCT00988208
Ethics application status
Date submitted
1/10/2009
Date registered
2/10/2009
Date last updated
4/04/2018

Titles & IDs
Public title
Study to Evaluate Safety and Effectiveness of Lenalidomide in Combination With Docetaxel and Prednisone for Patients With Castrate-Resistant Prostate Cancer
Scientific 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)
Secondary ID [1] 0 0
EudraCT Number 2008-007969-23
Secondary ID [2] 0 0
CC-5013-PC-002
Universal Trial Number (UTN)
Trial acronym
Mainsail
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Lenalidomide
Treatment: Drugs - Docetaxel
Treatment: Drugs - Prednisone
Treatment: Drugs - Placebo

Experimental: Docetaxel, Prednisone, Lenalidomide (DPL) - 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

Experimental: Docetaxel and Prednisone (DP) - 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


Treatment: Drugs: Lenalidomide
25 mg lenalidomide orally once each day on Days 1-14

Treatment: Drugs: Docetaxel
75 mg/m2 intravenous docetaxel on Day 1

Treatment: Drugs: Prednisone
5 mg prednisone orally twice daily on each day of the treatment cycle

Treatment: Drugs: Placebo
Oral placebo once each day on Days 1-14 of the treatment cycle
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
From randomization until death from any cause up to the cut-off date of 13 January 2012; up to approximately 26 months
Secondary outcome [1] 0 0
Progression-Free Survival (PFS)
Timepoint [1] 0 0
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
Secondary outcome [2] 0 0
Percentage of Participants With an Objective Response According to Response Evaluation Criteria in Solid Tumors - RECIST Version 1.1 Criteria
Timepoint [2] 0 0
From day 1 to data cut-off 13 January 2012; maximum time on study was approximately 26 months
Secondary outcome [3] 0 0
Number of Participants With Treatment Emergent Adverse Events (AEs)
Timepoint [3] 0 0
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
Secondary outcome [4] 0 0
Percentage of Participants Who Received Post-Study Therapies
Timepoint [4] 0 0
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
Secondary outcome [5] 0 0
Percentage of Participants With Secondary Primary Malignancies During the Course of the Trial
Timepoint [5] 0 0
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
Secondary outcome [6] 0 0
Time to Onset of Secondary Primary Malignancies
Timepoint [6] 0 0
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

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/11/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/11/2016
Sample size
Target
Accrual to date
Final
1059
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [3] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [4] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [5] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [6] 0 0
Port Macquarie Base Hospital - Port Macquarie
Recruitment hospital [7] 0 0
Redcliffe Hospital - Redcliffe
Recruitment hospital [8] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [9] 0 0
Newcastle Calvary Mater Hospital - Waratah
Recruitment hospital [10] 0 0
Westmead Hospital - Westmead
Recruitment hospital [11] 0 0
Border Medical Oncology - Wodonga
Recruitment hospital [12] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment hospital [13] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
SA 5000 - Adelaide
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3050 - Parkville
Recruitment postcode(s) [3] 0 0
5042 - Bedford Park
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NSW 2050 - Camperdown
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6009 - Nedlands
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NSW 2444 - Port Macquarie
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QLD 4020 - Redcliffe
Recruitment postcode(s) [8] 0 0
2065 - St Leonards
Recruitment postcode(s) [9] 0 0
2298 - Waratah
Recruitment postcode(s) [10] 0 0
NSW 2145 - Westmead
Recruitment postcode(s) [11] 0 0
3690 - Wodonga
Recruitment postcode(s) [12] 0 0
5011 - Woodville South
Recruitment postcode(s) [13] 0 0
QLD 4102 - Woolloongabba
Recruitment outside Australia
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Sochi
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Durban, KZ-Natal
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Polokwane
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Pretoria
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Barcelona
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Hospitalet de Llobregat, Barcelona
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Lérida
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Madrid
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Malaga
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Pamplona
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Terrassa (Barcelona)
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Valencia
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Spain
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Zaragoza
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Sweden
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Umeå
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Sweden
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Västerås
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Bebington, Wirral
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Cambridge
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Guildford
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Scunthorpe
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Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Celgene
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00988208
Trial related presentations / 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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Debora Barton, MD
Address 0 0
Celgene Corporation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00988208