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

Prostate Cancer Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00988208
• Other study ID #: CC-5013-PC-002
• Secondary ID: EudraCT Number 2
• Status: Completed
• Phase: Phase 3
• First received: October 1, 2009
• Last updated: March 9, 2018
• Start date: November 11, 2009
• Est. completion date: November 28, 2016

Study information

• Verified date: March 2018
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

The addition of lenalidomide to docetaxel and prednisone is proposed to increase the life expectancy of these subjects.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1059
• Est. completion date: November 28, 2016
• Est. primary completion date: January 13, 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Lenalidomide
25 mg lenalidomide orally once each day on Days 1-14
• Docetaxel
75 mg/m2 intravenous docetaxel on Day 1
• Prednisone
5 mg prednisone orally twice daily on each day of the treatment cycle
• Placebo
Oral placebo once each day on Days 1-14 of the treatment cycle

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Czechia,  Denmark,  France,  Germany,  Greece,  Hungary,  Israel,  Italy,  Mexico,  Netherlands,  Poland,  Russian Federation,  South Africa,  Spain,  Sweden,  United Kingdom, 

References & Publications (3)

de Morrée 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. Asso — View 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 predni — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From randomization until death from any cause up to the cut-off date of 13 January 2012; up to approximately 26 months
Secondary	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	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	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	From day 1 to data cut-off 13 January 2012; maximum time on study was approximately 26 months
Secondary	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;	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	Percentage of Participants Who Received Post-Study Therapies	Percentage of Participants Who Received Post-Study Therapies for advanced Prostate Cancer.	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	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.	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	Time to Onset of Secondary Primary Malignancies	Time of Onset of Secondary Primary Malignancies was considered an event of interest	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