Prostate Cancer Clinical Trial

Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients

Summary

The purpose of this study is to determine if continued treatment with Enzalutamide is effective in patients with metastatic prostate cancer.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Men with metastatic castration-resistant prostate cancer
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 cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone, or enzalutamide for the treatment of prostate cancer
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

Study is for people with:

Prostate Cancer

Phase:

Phase 4

Estimated Enrollment:

509

Study ID:

NCT01995513

Recruitment Status:

Completed

Sponsor:

Pfizer

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There are 65 Locations for this study

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Beth Israel Deaconess Medical Center
Boston Massachusetts, 02115, United States
Brigham & Women's Hospital
Boston Massachusetts, 02115, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
Urology of Virginia, PLLC
Virginia Beach Virginia, 23462, United States
Regional Imaging Border
Albury New South Wales, 2640, Australia
Terry White Chemist
Albury New South Wales, 2640, Australia
Concord Cancer Centre, Medical Oncology Department
Concord New South Wales, 2139, Australia
Epic Pharmacy Lismore
Lismore New South Wales, 2480, Australia
Macquarie University Hospital Pharmacy
North Ryde New South Wales, 2109, Australia
Macquarie University
North Ryde New South Wales, 2109, Australia
Epic Pharmacy Port Macquarie base hospital
Port Macquarie New South Wales, 2444, Australia
Port Macquarie Base Hospital,North Coast Cancer Institute
Port Macquarie New South Wales, 2444, Australia
North Shore Radiology and Nuclear Medicine
St Leonards New South Wales, 2065, Australia
Royal North Shore Hospital
St Leonards New South Wales, 2065, Australia
Sydney Adventist Hospital
Sydney New South Wales, 2076, Australia
Northern NSW Local Health District
Tweed Heads New South Wales, 2485, Australia
Pharmacy Department, The Tweed Hospital
Tweed Heads New South Wales, 2485, Australia
Queensland Diagnostic Imaging
Tweed Heads New South Wales, 2485, Australia
Sydney Adventist Hospital
Wahroonga New South Wales, 2076, Australia
Westmead Hospital
Westmead New South Wales, 2145, Australia
Icon Cancer Care Wesley
Auchenflower Queensland, 4066, Australia
River City Pharmacy - APHS
Auchenflower Queensland, 4066, Australia
Icon Cancer Care Chermside
Chermside Queensland, 4032, Australia
Gold Coast Radiology PTY LTD
Hope Island Queensland, 4212, Australia
Icon Cancer Care South Brisbane
South Brisbane Queensland, 4101, Australia
Icon Cancer Care
South Brisbane Queensland, 4101, Australia
South Coast Radiology
Tugun Queensland, 4224, Australia
Adelaide Cancer Centre
Kurralta Park South Australia, 5037, Australia
Ashford Cancer Centre Research
Kurralta Park South Australia, 5037, Australia
Cancer Care SA Pty Ltd
Kurralta Park South Australia, 5037, Australia
Tenpharm Pty Ltd trading as EPIC Pharmacy Tennyson
Kurralta Park South Australia, 5037, Australia
Box Hill Hospital
Box Hill Victoria, 3128, Australia
Monash Medical Centre
Clayton Victoria, 3168, Australia
Cabrini Health - Cabrini Hospital
Malvern Victoria, 3144, Australia
Border Medical Oncology
Wodonga Victoria, 3690, Australia
Algemeen Ziekenhuis Groeninge
Kortrijk West-vlaanderen, 8500, Belgium
Cliniques universitaires saint-Luc
Bruxelles , 1200, Belgium
Universitaire Ziekenhuizen Leuven
Leuven , 3000, Belgium
Rigshospitalet CPC 7521
Copenhagen Norrebro, 2200, Denmark
Arhus Universitetshospital
Arhus N , 8200, Denmark
Rigshospitalet
Copenhagen , 2100, Denmark
Frederiksberg Hospital
Frederiksberg , 2000, Denmark
Helsingin yliopistollinen keskussairaala, Meilahden sairaala
Helsinki , 00290, Finland
Oulun yliopistollinen sairaala
Oulu , 90220, Finland
Tampereen yliopistollinen Sairaala
Tampere , 33520, Finland
Institut Gustave Roussy - Service d'Urologie
Villejuif Cedex , 94805, France
U.O. Oncologia Medica, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura
Meldola FC, 47014, Italy
Farmacia, Azienda Ospedaliera "Istituti Ospitalieri" di Cremona
Cremona , 26100, Italy
Medicina Nucleare, Azienda Ospedaliera "Istituti Ospitalieri" di Cremona
Cremona , 26100, Italy
Servizio di Radiologia, Azienda Ospedaliera "Istituti Ospitalieri" di Cremona
Cremona , 26100, Italy
U.O di Oncologia-Presidio Ospedaliero di Cremona-Istituti Ospitalieri di Cremona
Cremona , 26100, Italy
Laboratorio Farmaci Antiblastici
Meldola (FC) , 47014, Italy
UO Radiologia
Meldola (FC) , 47014, Italy
Farmacia Ospedaliera, A.O.U. San Luigi Gonzaga
Orbassano TO , 10043, Italy
SCDU Oncologia Medica II Pad, A.O.U. San Luigi Gonzaga
Orbassano TO , 10043, Italy
SCDU Radiodiagnostica, A.O.U. San Luigi Gonzaga
Orbassano TO , 10043, Italy
SS Medicina Nucleare, A.O.U. San Luigi Gonzaga
Orbassano TO , 10043, Italy
Azienda Ospedaliera S. Camillo Forlanini, UOC per il governo clinico in Oncologia Medica
Roma , 00152, Italy
Farmacia, Azienda Ospedaliera S. Camillo Forlanini
Roma , 00152, Italy
UOC Radiologia Piasta, Azienda Ospedaliera S. Camillo Forlanini
Roma , 00512, Italy
Fakultna nemocnica s poliklinikou F.D. Roosevelta
Banska Bystrica , 975 1, Slovakia
Institut nuklearnej a molekularnej mediciny
Banska Bystrica , 975 1, Slovakia
Fakultna nemocnica s poliklinikou F.D. Roosevelta
Banska Bystrica , 97517, Slovakia
Bratislavske radiodiagnosticke centrum,a.s.
Bratislava , 814 9, Slovakia
CUIMED, s.r.o., urologicka ambulancia
Bratislava , 851 0, Slovakia
Univerzitna nemocnica martin
Martin , 036 5, Slovakia
Jessenius-diagnosticke centrum, a.s.
Nitra , 949 0, Slovakia
Uroexam, spol. s r.o., Urologicka ambulancia
Nitra , 949 0, Slovakia
IZOTOPCENTRUM, s.r.o.
Nitra , 950 0, Slovakia
GAMMALAB, spol.s r.o., Oddelenie nuklearnej mediciny
Trnava , 917 0, Slovakia
CO Badalona-Instituto Germans Trias i Pujol
Badalona Barcelona, 08916, Spain
ALTAHIA, Xarxa Assistencial Universitaria de Manresa
Manresa Barcelona, 08243, Spain
Hospital Universitari Parc Tauli
Sabadell Barcelona, 08208, Spain
Hospital Universitario Son Espases
Palma Islas Baleares, 07120, Spain
Hospital del Mar
Barcelona , 08003, Spain
Hospital Clinic de Barcelona
Barcelona , 08036, Spain
Hospital Universitario Madrid Sanchinarro
Madrid , 28050, Spain
Urologmottagningen
Goteborg , 41345, Sweden
Urologiska kliniken
Malmo , 20502, Sweden
Oriola
Molnlycke , 435 2, Sweden
Apoteket AB Kliniska Provningar Molnlycke
Molnlycke , 435 3, Sweden
Rontgenkliniken
Orebro , 701 8, Sweden
Urologmottagningen
Orebro , 701 8, Sweden
East and North Hertfordshire NHS Trust
Northwood Middlesex, HA6 2, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton Surrey, SM2 5, United Kingdom
Velindre NHS Trust
Cardiff , CF14 , United Kingdom
University College Hospitals NHS Trust
London , NW1 2, United Kingdom
The Royal Marsden NHS Foundation Trust
London , SW3 6, United Kingdom
University College London Hospitals NHS Foundation Trust
London , WC1E , United Kingdom
Oxford University Hospitals NHS Trust
Oxford , OX3 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 4

Estimated Enrollment:

509

Study ID:

NCT01995513

Recruitment Status:

Completed

Sponsor:


Pfizer

How clear is this clinincal trial information?

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