Clinical trial NCT01995513: Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients
Official title: A PHASE 4, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF CONTINUED ENZALUTAMIDE TREATMENT BEYOND PROGRESSION IN PATIENTS WITH CHEMOTHERAPY-NAÏVE METASTATIC CASTRATION-RESISTANT PROSTATE CANCER
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prostate Cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma Inc
name: Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
First posted: 2013-11-26
Enrollment: 509
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: From randomization until disease progression, last tumor assessment without disease progression or death due to any cause, whichever occurred first (maximum up to 20.3 months)
Secondary outcomes:
measure: Time to Prostate Specific Antigen (PSA) Progression
timeFrame: From randomization until disease progression, last tumor assessment without disease progression, whichever occurred first (maximum up to 11.1 months)
measure: Prostate Specific Antigen (PSA) Response Rate
timeFrame: From randomization until disease progression, last tumor assessment without disease progression, whichever occurred first (maximum up to 11.1 months)
measure: Objective Response Rate (ORR)
timeFrame: From randomization until CR or PR, whichever occurred first (maximum up to 21.3 months)
measure: Rate of Pain Progression
timeFrame: Month 6
measure: Time to First Use of New Antineoplastic Therapy for Prostate Cancer
timeFrame: From randomization until date of first use of any antineoplastic therapy (after last dose date of Period 2, maximum up to 22.3 months
measure: Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
timeFrame: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
measure: Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores
timeFrame: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
measure: Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores
timeFrame: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
measure: Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores
timeFrame: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
measure: Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores
timeFrame: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
measure: Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores
timeFrame: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
measure: Time to Degradation of the Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
timeFrame: From randomization up to maximum of 18.4 months
Other outcomes:
measure: Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum of 99.4 months)
measure: Percentage of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation
timeFrame: Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum of 99.4 months)
measure: Percentage of Participants With Adverse Events (AEs) Leading to Death
timeFrame: Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum of 99.4 months)
measure: Percentage of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum of 99.4 months)
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Philadelphia
country: United States
facility: eResearch Technology
state: Pennsylvania
city: Virginia Beach
country: United States
facility: Urology of Virginia, PLLC
state: Virginia
city: Albury
country: Australia
facility: Border Medical Oncology Research Unit
state: New South Wales
city: Albury
country: Australia
facility: Ramsay Health Care Australia Pty Ltd
state: New South Wales
city: Albury
country: Australia
facility: Regional Imaging Border
state: New South Wales
city: Albury
country: Australia
facility: Terry White Chemist
state: New South Wales
city: Concord
country: Australia
facility: Concord Cancer Centre, Medical Oncology Department
state: New South Wales
city: Concord
country: Australia
facility: Concord Hospital Clinical Trials Pharmacy
state: New South Wales
city: Lismore
country: Australia
facility: Epic Pharmacy Lismore
state: New South Wales
city: North Ryde
country: Australia
facility: Macquarie University Hospital Pharmacy
state: New South Wales
city: North Ryde
country: Australia
facility: Macquarie University
state: New South Wales
city: Port Macquarie
country: Australia
facility: Epic Pharmacy Port Macquarie base hospital
state: New South Wales
city: Port Macquarie
country: Australia
facility: Port Macquarie Base Hospital,North Coast Cancer Institute
state: New South Wales
city: St Leonards
country: Australia
facility: North Shore Radiology and Nuclear Medicine
state: New South Wales
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Sydney Adventist Hospital
state: New South Wales
city: Tweed Heads
country: Australia
facility: Northern NSW Local Health District
state: New South Wales
city: Tweed Heads
country: Australia
facility: Queensland Diagnostic Imaging
state: New South Wales
city: Wahroonga
country: Australia
facility: Sydney Adventist Hospital
state: New South Wales
city: West Albury
country: Australia
facility: Regional Imaging
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Auchenflower
country: Australia
facility: Icon Cancer Care Wesley
state: Queensland
city: Auchenflower
country: Australia
facility: River City Pharmacy - APHS
state: Queensland
city: Chermside
country: Australia
facility: Icon Cancer Care Chermside
state: Queensland
city: Hope Island
country: Australia
facility: Gold Coast Radiology PTY LTD
state: Queensland
city: South Brisbane
country: Australia
facility: Icon Cancer Care South Brisbane
state: Queensland
city: South Brisbane
country: Australia
facility: Icon Cancer Care
state: Queensland
city: Tugun
country: Australia
facility: South Coast Radiology
state: Queensland
city: Kurralta Park
country: Australia
facility: Adelaide Cancer Centre
state: South Australia
city: Kurralta Park
country: Australia
facility: Ashford Cancer Centre Research
state: South Australia
city: Kurralta Park
country: Australia
facility: Cancer Care SA Pty Ltd
state: South Australia
city: Kurralta Park
country: Australia
facility: Tenpharm Pty Ltd trading as EPIC Pharmacy Tennyson
state: South Australia
city: Bentleigh East
country: Australia
facility: Moorabbin Radiology
state: Victoria
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Malvern
country: Australia
facility: Cabrini Health - Cabrini Hospital
state: Victoria
city: Wodonga
country: Australia
facility: Border Medical Oncology
state: Victoria
city: Kortrijk
country: Belgium
facility: Algemeen Ziekenhuis Groeninge
state: West-vlaanderen
city: Bruxelles
country: Belgium
facility: Cliniques universitaires saint-Luc
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven
city: Copenhagen
country: Denmark
facility: Rigshospitalet CPC 7521
state: Norrebro
city: Arhus N
country: Denmark
facility: Arhus Universitetshospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Frederiksberg
country: Denmark
facility: Frederiksberg Hospital
city: Helsinki
country: Finland
facility: Helsingin yliopistollinen keskussairaala, Meilahden sairaala
city: Oulu
country: Finland
facility: Oulun yliopistollinen sairaala
city: Tampere
country: Finland
facility: Tampereen yliopistollinen Sairaala
city: Villejuif Cedex
country: France
facility: Institut Gustave Roussy - Service d'Urologie
city: Meldola
country: Italy
facility: U.O. Oncologia Medica, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura
state: FC
city: Cremona
country: Italy
facility: Medicina Nucleare, Azienda Ospedaliera "Istituti Ospitalieri" di Cremona
city: Cremona
country: Italy
facility: Servizio di Radiologia, Azienda Ospedaliera "Istituti Ospitalieri" di Cremona
city: Cremona
country: Italy
facility: Struttura Complessa di Oncologia, Azienda Socio Sanitaria Territoriale di Cremona
city: Meldola (FC)
country: Italy
facility: Laboratorio Farmaci Antiblastici
city: Meldola (FC)
country: Italy
facility: UO Radiologia
city: Orbassano TO
country: Italy
facility: SCDU Oncologia Medica II Pad, A.O.U. San Luigi Gonzaga
city: Orbassano TO
country: Italy
facility: SCDU Radiodiagnostica, A.O.U. San Luigi Gonzaga
city: Orbassano TO
country: Italy
facility: SS Medicina Nucleare, A.O.U. San Luigi Gonzaga
city: Roma
country: Italy
facility: Azienda Ospedaliera S. Camillo Forlanini, UOC per il governo clinico in Oncologia Medica
city: Roma
country: Italy
facility: UOC Radiologia Piasta, Azienda Ospedaliera S. Camillo Forlanini
city: Banska Bystrica
country: Slovakia
facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta
city: Banska Bystrica
country: Slovakia
facility: Institut nuklearnej a molekularnej mediciny
city: Banska Bystrica
country: Slovakia
facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta
city: Bratislava
country: Slovakia
facility: Bratislavske radiodiagnosticke centrum,a.s.
city: Bratislava
country: Slovakia
facility: CUIMED, s.r.o., urologicka ambulancia
city: Martin
country: Slovakia
facility: Univerzitna nemocnica martin
city: Nitra
country: Slovakia
facility: Jessenius-diagnosticke centrum, a.s.
city: Nitra
country: Slovakia
facility: Uroexam, spol. s r.o., Urologicka ambulancia
city: Nitra
country: Slovakia
facility: IZOTOPCENTRUM, s.r.o.
city: Trnava
country: Slovakia
facility: GAMMALAB, spol.s r.o., Oddelenie nuklearnej mediciny
city: Badalona,
country: Spain
facility: ICO Badalona-Instituto Germans Trias i Pujol
state: Barcelona
city: Badalona
country: Spain
facility: CO Badalona-Instituto Germans Trias i Pujol
state: Barcelona
city: Manresa
country: Spain
facility: ALTAHIA, Xarxa Assistencial Universitaria de Manresa
state: Barcelona
city: Sabadell
country: Spain
facility: Hospital Universitari Parc Tauli
state: Barcelona
city: Badalona,
country: Spain
facility: ICO Badalona-Instituto Germans Trias i Pujol
state: Barcelon
city: Palma
country: Spain
facility: Hospital Universitario Son Espases
state: Islas Baleares
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario Madrid Sanchinarro
city: Goteborg
country: Sweden
facility: Urologmottagningen
city: Malmo
country: Sweden
facility: Urologiska kliniken
city: Molnlycke
country: Sweden
facility: Oriola
city: Molnlycke
country: Sweden
facility: Apoteket AB Kliniska Provningar Molnlycke
city: Orebro
country: Sweden
facility: Rontgenkliniken
city: Orebro
country: Sweden
facility: Urologmottagningen
city: Northwood
country: United Kingdom
facility: East and North Hertfordshire NHS Trust
state: Middlesex
city: Sutton
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
state: Surrey
city: Cardiff
country: United Kingdom
facility: Velindre NHS Trust
city: London
country: United Kingdom
facility: University College Hospitals NHS Trust
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Trust
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
affiliation: Medviation, Inc.
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.