Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients
NCT ID: NCT01995513
Last Updated: 2023-09-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
509 participants
INTERVENTIONAL
2013-10-22
2022-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Enzalutamide & Abiraterone/prednisone
Enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with abiraterone (1000 mg) administered as four 250-mg tablets by mouth once daily and prednisone (10 mg) administered as one 5-mg tablet by mouth twice daily
Enzalutamide
160 mg by mouth once daily
Abiraterone
1000 mg by mouth once daily
Prednisone
5 mg by mouth twice daily
Enzalutamide placebo & Abiraterone/prednisone
Enzalutamide placebo (placebo) capsules (identical in appearance to enzalutamide) administered as 4 capsules by mouth once daily in combination with abiraterone (1000 mg) administered as four 250-mg tablets by mouth once daily and prednisone (10 mg) administered as one 5-mg tablet by mouth twice daily.
Abiraterone
1000 mg by mouth once daily
Placebo for Enzalutamide
Sugar pill manufactured to mimic Enzalutamide 40 mg capsule
Prednisone
5 mg by mouth twice daily
Interventions
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Enzalutamide
160 mg by mouth once daily
Abiraterone
1000 mg by mouth once daily
Placebo for Enzalutamide
Sugar pill manufactured to mimic Enzalutamide 40 mg capsule
Prednisone
5 mg by mouth twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Progressive disease on androgen deprivation therapy
* Patients must agree to continue androgen deprivation therapy with a GnRH agonist/antagonist throughout the study or have had a prior bilateral orchiectomy
* ECOG performance score ≤ 1
* Estimated life expectancy of ≥ 12 months
Exclusion Criteria
* Prior participation in a clinical trial of an investigational agent that inhibits the androgen receptor or androgen synthesis (unless the treatment was placebo)
* History of brain metastasis, active leptomeningeal disease or seizure
* Severe cardiovascular or hepatic disease
* Pituitary or adrenal dysfunction
18 Years
MALE
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
INDUSTRY
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Medical Director
Role: STUDY_DIRECTOR
Medviation, Inc.
Locations
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Icon Cancer Care
South Brisbane, Queensland, Australia
South Coast Radiology
Tugun, Queensland, Australia
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
eResearch Technology
Philadelphia, Pennsylvania, United States
Urology of Virginia, PLLC
Virginia Beach, Virginia, United States
Border Medical Oncology Research Unit
Albury, New South Wales, Australia
Ramsay Health Care Australia Pty Ltd
Albury, New South Wales, Australia
Regional Imaging Border
Albury, New South Wales, Australia
Terry White Chemist
Albury, New South Wales, Australia
Concord Cancer Centre, Medical Oncology Department
Concord, New South Wales, Australia
Concord Hospital Clinical Trials Pharmacy
Concord, New South Wales, Australia
Epic Pharmacy Lismore
Lismore, New South Wales, Australia
Macquarie University Hospital Pharmacy
North Ryde, New South Wales, Australia
Macquarie University
North Ryde, New South Wales, Australia
Epic Pharmacy Port Macquarie base hospital
Port Macquarie, New South Wales, Australia
Port Macquarie Base Hospital,North Coast Cancer Institute
Port Macquarie, New South Wales, Australia
North Shore Radiology and Nuclear Medicine
St Leonards, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Sydney Adventist Hospital
Sydney, New South Wales, Australia
Northern NSW Local Health District
Tweed Heads, New South Wales, Australia
Queensland Diagnostic Imaging
Tweed Heads, New South Wales, Australia
Sydney Adventist Hospital
Wahroonga, New South Wales, Australia
Regional Imaging
West Albury, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Icon Cancer Care Wesley
Auchenflower, Queensland, Australia
River City Pharmacy - APHS
Auchenflower, Queensland, Australia
Icon Cancer Care Chermside
Chermside, Queensland, Australia
Gold Coast Radiology PTY LTD
Hope Island, Queensland, Australia
Icon Cancer Care South Brisbane
South Brisbane, Queensland, Australia
Adelaide Cancer Centre
Kurralta Park, South Australia, Australia
Ashford Cancer Centre Research
Kurralta Park, South Australia, Australia
Cancer Care SA Pty Ltd
Kurralta Park, South Australia, Australia
Tenpharm Pty Ltd trading as EPIC Pharmacy Tennyson
Kurralta Park, South Australia, Australia
Moorabbin Radiology
Bentleigh East, Victoria, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Cabrini Health - Cabrini Hospital
Malvern, Victoria, Australia
Border Medical Oncology
Wodonga, Victoria, Australia
Algemeen Ziekenhuis Groeninge
Kortrijk, West-vlaanderen, Belgium
Cliniques universitaires saint-Luc
Brussels, , Belgium
Universitaire Ziekenhuizen Leuven
Leuven, , Belgium
Rigshospitalet CPC 7521
Copenhagen, Norrebro, Denmark
Arhus Universitetshospital
Arhus N, , Denmark
Rigshospitalet
Copenhagen, , Denmark
Frederiksberg Hospital
Frederiksberg, , Denmark
Helsingin yliopistollinen keskussairaala, Meilahden sairaala
Helsinki, , Finland
Oulun yliopistollinen sairaala
Oulu, , Finland
Tampereen yliopistollinen Sairaala
Tampere, , Finland
Institut Gustave Roussy - Service d'Urologie
Villejuif, , France
U.O. Oncologia Medica, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura
Meldola, FC, Italy
Medicina Nucleare, Azienda Ospedaliera "Istituti Ospitalieri" di Cremona
Cremona, , Italy
Servizio di Radiologia, Azienda Ospedaliera "Istituti Ospitalieri" di Cremona
Cremona, , Italy
Struttura Complessa di Oncologia, Azienda Socio Sanitaria Territoriale di Cremona
Cremona, , Italy
Laboratorio Farmaci Antiblastici
Meldola (FC), , Italy
UO Radiologia
Meldola (FC), , Italy
SCDU Oncologia Medica II Pad, A.O.U. San Luigi Gonzaga
Orbassano to, , Italy
SCDU Radiodiagnostica, A.O.U. San Luigi Gonzaga
Orbassano to, , Italy
SS Medicina Nucleare, A.O.U. San Luigi Gonzaga
Orbassano to, , Italy
Azienda Ospedaliera S. Camillo Forlanini, UOC per il governo clinico in Oncologia Medica
Roma, , Italy
UOC Radiologia Piasta, Azienda Ospedaliera S. Camillo Forlanini
Roma, , Italy
Fakultna nemocnica s poliklinikou F.D. Roosevelta
Banská Bystrica, , Slovakia
Institut nuklearnej a molekularnej mediciny
Banská Bystrica, , Slovakia
Fakultna nemocnica s poliklinikou F.D. Roosevelta
Banská Bystrica, , Slovakia
Bratislavske radiodiagnosticke centrum,a.s.
Bratislava, , Slovakia
CUIMED, s.r.o., urologicka ambulancia
Bratislava, , Slovakia
Univerzitna nemocnica martin
Martin, , Slovakia
Jessenius-diagnosticke centrum, a.s.
Nitra, , Slovakia
Uroexam, spol. s r.o., Urologicka ambulancia
Nitra, , Slovakia
IZOTOPCENTRUM, s.r.o.
Nitra, , Slovakia
GAMMALAB, spol.s r.o., Oddelenie nuklearnej mediciny
Trnava, , Slovakia
Hospital Universitario Son Espases
Palma, Balearic Islands, Spain
CO Badalona-Instituto Germans Trias i Pujol
Badalona, Barcelona, Spain
ICO Badalona-Instituto Germans Trias i Pujol
Badalona, Barcelona, Spain
ALTAHIA, Xarxa Assistencial Universitaria de Manresa
Manresa, Barcelona, Spain
Hospital Universitari Parc Tauli
Sabadell, Barcelona, Spain
ICO Badalona-Instituto Germans Trias i Pujol
Badalona, Barcelon, Spain
Hospital del Mar
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitario Madrid Sanchinarro
Madrid, , Spain
Urologmottagningen
Gothenburg, , Sweden
Urologiska kliniken
Malmo, , Sweden
Oriola
Mölnlycke, , Sweden
Apoteket AB Kliniska Provningar Molnlycke
Mölnlycke, , Sweden
Rontgenkliniken
Örebro, , Sweden
Urologmottagningen
Örebro, , Sweden
East and North Hertfordshire NHS Trust
Northwood, Middlesex, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom
Velindre NHS Trust
Cardiff, , United Kingdom
University College Hospitals NHS Trust
London, , United Kingdom
The Royal Marsden NHS Foundation Trust
London, , United Kingdom
University College London Hospitals NHS Foundation Trust
London, , United Kingdom
Oxford University Hospitals NHS Trust
Oxford, , United Kingdom
Countries
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References
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Attard G, Borre M, Gurney H, Loriot Y, Andresen-Daniil C, Kalleda R, Pham T, Taplin ME; PLATO collaborators. Abiraterone Alone or in Combination With Enzalutamide in Metastatic Castration-Resistant Prostate Cancer With Rising Prostate-Specific Antigen During Enzalutamide Treatment. J Clin Oncol. 2018 Sep 1;36(25):2639-2646. doi: 10.1200/JCO.2018.77.9827. Epub 2018 Jul 20.
Other Identifiers
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2013-000722-54
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C3431013
Identifier Type: OTHER
Identifier Source: secondary_id
PLATO, C3431013
Identifier Type: OTHER
Identifier Source: secondary_id
MDV3100-10
Identifier Type: -
Identifier Source: org_study_id
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