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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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) - 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.
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) - 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
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 - 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
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) - 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;
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 - Percentage of Participants Who Received Post-Study Therapies for advanced Prostate Cancer.
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 - Second primary malignancies were monitored as events of interest and reported as serious adverse events throughout 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 - Time of Onset of Secondary Primary Malignancies was considered an event of interest
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
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Royal Melbourne Hospital - Parkville
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Flinders Medical Centre - Bedford Park
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Chris O'Brien Lifehouse - Camperdown
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Sir Charles Gairdner Hospital - Nedlands
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Port Macquarie Base Hospital - Port Macquarie
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Redcliffe Hospital - Redcliffe
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Royal North Shore Hospital - St Leonards
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Newcastle Calvary Mater Hospital - Waratah
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Westmead Hospital - Westmead
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Border Medical Oncology - Wodonga
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The Queen Elizabeth Hospital - Woodville South
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Princess Alexandra Hospital - Woolloongabba
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SA 5000 - Adelaide
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3050 - Parkville
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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
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2065 - St Leonards
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2298 - Waratah
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NSW 2145 - Westmead
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3690 - Wodonga
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5011 - Woodville South
Recruitment postcode(s) [13] 0 0
QLD 4102 - Woolloongabba
Recruitment outside Australia
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Sochi
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Polokwane
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South Africa
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Pretoria
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Spain
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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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Jönköping
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Sweden
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Umeå
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Sweden
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Västerås
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United Kingdom
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Bebington, Wirral
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United Kingdom
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Cambridge
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United Kingdom
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Guildford
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London
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Manchester
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Nottingham
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Scunthorpe
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United Kingdom
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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/show/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.
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
Other publications