Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients
PLATO
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
4 other identifiers
interventional
509
11 countries
95
Brief Summary
The purpose of this study is to determine if continued treatment with Enzalutamide is effective in patients with metastatic prostate cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 prostate-cancer
Started Oct 2013
Longer than P75 for phase_4 prostate-cancer
95 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 22, 2013
CompletedFirst Submitted
Initial submission to the registry
November 18, 2013
CompletedFirst Posted
Study publicly available on registry
November 26, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2016
CompletedResults Posted
Study results publicly available
November 17, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2022
CompletedSeptember 18, 2023
August 1, 2023
3.1 years
November 18, 2013
October 13, 2017
August 22, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS)
PFS = time from randomization to first documentation of radiographic progression (RP),unequivocal clinical progression or death due to any cause (death within 112 days of treatment discontinuation without objective evidence of RP),whichever occurred first as per investigator. Unequivocal disease progression was pain requiring chronic administration of analgesics, decline of prostate cancer of Eastern Cooperative Oncology Group (ECOG) performance status score to 3 or higher or initiation of new anticancer therapy/radiation therapy or surgical intervention due to tumor progression. ECOG score range= 0(no severity) to 5(maximum severity).RP for bone disease was evaluated by appearance of 2 or more new bone lesions as per Prostate Cancer Clinical Trials Working Group 2 (PCWG2) or for soft tissue disease according to Response Evaluation Criteria in Solid Tumor version 1.1. Participants with no PFS event at analysis date were censored at last tumor assessment date prior to data cutoff date.
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 (12)
Time to Prostate Specific Antigen (PSA) Progression
From randomization until disease progression, last tumor assessment without disease progression, whichever occurred first (maximum up to 11.1 months)
Prostate Specific Antigen (PSA) Response Rate
From randomization until disease progression, last tumor assessment without disease progression, whichever occurred first (maximum up to 11.1 months)
Objective Response Rate (ORR)
From randomization until CR or PR, whichever occurred first (maximum up to 21.3 months)
Rate of Pain Progression
Month 6
Time to First Use of New Antineoplastic Therapy for Prostate Cancer
From randomization until date of first use of any antineoplastic therapy (after last dose date of Period 2, maximum up to 22.3 months
- +7 more secondary outcomes
Other Outcomes (4)
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
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)
Percentage of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation
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)
Percentage of Participants With Adverse Events (AEs) Leading to Death
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)
- +1 more other outcomes
Study Arms (2)
Enzalutamide & Abiraterone/prednisone
EXPERIMENTALEnzalutamide (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 placebo & Abiraterone/prednisone
ACTIVE COMPARATOREnzalutamide 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.
Interventions
160 mg by mouth once daily
1000 mg by mouth once daily
Sugar pill manufactured to mimic Enzalutamide 40 mg capsule
5 mg by mouth twice daily
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- Astellas Pharma Inccollaborator
- Medivation LLC, a wholly owned subsidiary of Pfizer Inc.collaborator
Study Sites (95)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115, United States
Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
eResearch Technology
Philadelphia, Pennsylvania, 19103, United States
Urology of Virginia, PLLC
Virginia Beach, Virginia, 23462, United States
Border Medical Oncology Research Unit
Albury, New South Wales, 2640, Australia
Ramsay Health Care Australia Pty Ltd
Albury, New South Wales, 2640, Australia
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
Concord Hospital Clinical Trials Pharmacy
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
Queensland Diagnostic Imaging
Tweed Heads, New South Wales, 2485, Australia
Sydney Adventist Hospital
Wahroonga, New South Wales, 2076, Australia
Regional Imaging
West Albury, New South Wales, 2640, 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
Moorabbin Radiology
Bentleigh East, Victoria, 3165, 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
Brussels, 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, 94805, France
U.O. Oncologia Medica, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura
Meldola, FC, 47014, Italy
Medicina Nucleare, Azienda Ospedaliera "Istituti Ospitalieri" di Cremona
Cremona, 26100, Italy
Servizio di Radiologia, Azienda Ospedaliera "Istituti Ospitalieri" di Cremona
Cremona, 26100, Italy
Struttura Complessa di Oncologia, Azienda Socio Sanitaria Territoriale di Cremona
Cremona, 26100, Italy
Laboratorio Farmaci Antiblastici
Meldola (FC), 47014, Italy
UO Radiologia
Meldola (FC), 47014, 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
UOC Radiologia Piasta, Azienda Ospedaliera S. Camillo Forlanini
Roma, 00512, Italy
Fakultna nemocnica s poliklinikou F.D. Roosevelta
Banská Bystrica, 975 17, Slovakia
Institut nuklearnej a molekularnej mediciny
Banská Bystrica, 975 17, Slovakia
Fakultna nemocnica s poliklinikou F.D. Roosevelta
Banská Bystrica, 97517, Slovakia
Bratislavske radiodiagnosticke centrum,a.s.
Bratislava, 814 99, Slovakia
CUIMED, s.r.o., urologicka ambulancia
Bratislava, 851 05, Slovakia
Univerzitna nemocnica martin
Martin, 036 59, Slovakia
Jessenius-diagnosticke centrum, a.s.
Nitra, 949 01, Slovakia
Uroexam, spol. s r.o., Urologicka ambulancia
Nitra, 949 01, Slovakia
IZOTOPCENTRUM, s.r.o.
Nitra, 950 01, Slovakia
GAMMALAB, spol.s r.o., Oddelenie nuklearnej mediciny
Trnava, 917 01, Slovakia
Hospital Universitario Son Espases
Palma, Balearic Islands, 07120, Spain
CO Badalona-Instituto Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
ICO 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
ICO Badalona-Instituto Germans Trias i Pujol
Badalona, Barcelon, 08916, Spain
Hospital del Mar
Barcelona, 08003, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Hospital Universitario Madrid Sanchinarro
Madrid, 28050, Spain
Urologmottagningen
Gothenburg, 41345, Sweden
Urologiska kliniken
Malmo, 20502, Sweden
Oriola
Mölnlycke, 435 25, Sweden
Apoteket AB Kliniska Provningar Molnlycke
Mölnlycke, 435 33, Sweden
Rontgenkliniken
Örebro, 701 85, Sweden
Urologmottagningen
Örebro, 701 85, Sweden
East and North Hertfordshire NHS Trust
Northwood, Middlesex, HA6 2RN, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT, United Kingdom
Velindre NHS Trust
Cardiff, CF14 2TL, United Kingdom
University College Hospitals NHS Trust
London, NW1 2BU, United Kingdom
The Royal Marsden NHS Foundation Trust
London, SW3 6JJ, United Kingdom
University College London Hospitals NHS Foundation Trust
London, WC1E 6AG, United Kingdom
Oxford University Hospitals NHS Trust
Oxford, OX3 7LE, United Kingdom
Related Publications (1)
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.
PMID: 30028657DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
- STUDY DIRECTOR
Medical Director
Medviation, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2013
First Posted
November 26, 2013
Study Start
October 22, 2013
Primary Completion
November 15, 2016
Study Completion
August 31, 2022
Last Updated
September 18, 2023
Results First Posted
November 17, 2017
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.