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

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

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Enzalutamide; Drug: Abiraterone; Drug: Prednisone; Drug: Placebo for Enzalutamide

• Study Type: Interventional
• Enrollment (Actual): 509
• Phase: Phase 4

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Albury, New South Wales, Australia, 2640
      • Border Medical Oncology Research Unit
    • Albury, New South Wales, Australia, 2640
      • Ramsay Health Care Australia Pty Ltd
    • Albury, New South Wales, Australia, 2640
      • Regional Imaging Border
    • Albury, New South Wales, Australia, 2640
      • Terry White Chemist
    • Concord, New South Wales, Australia, 2139
      • Concord Cancer Centre, Medical Oncology Department
    • Concord, New South Wales, Australia, 2139
      • Concord Hospital Clinical Trials Pharmacy
    • Lismore, New South Wales, Australia, 2480
      • Epic Pharmacy Lismore
    • North Ryde, New South Wales, Australia, 2109
      • Macquarie University
    • North Ryde, New South Wales, Australia, 2109
      • Macquarie University Hospital Pharmacy
    • Port Macquarie, New South Wales, Australia, 2444
      • Epic Pharmacy Port Macquarie base hospital
    • Port Macquarie, New South Wales, Australia, 2444
      • Port Macquarie Base Hospital,North Coast Cancer Institute
    • St Leonards, New South Wales, Australia, 2065
      • Royal North Shore Hospital
    • St Leonards, New South Wales, Australia, 2065
      • North Shore Radiology and Nuclear Medicine
    • Sydney, New South Wales, Australia, 2076
      • Sydney Adventist Hospital
    • Tweed Heads, New South Wales, Australia, 2485
      • Northern NSW Local Health District
    • Tweed Heads, New South Wales, Australia, 2485
      • Queensland Diagnostic Imaging
    • Wahroonga, New South Wales, Australia, 2076
      • Sydney Adventist Hospital
    • West Albury, New South Wales, Australia, 2640
      • Regional Imaging
    • Westmead, New South Wales, Australia, 2145
      • Westmead Hospital
  • Queensland
    • Auchenflower, Queensland, Australia, 4066
      • Icon Cancer Care Wesley
    • Auchenflower, Queensland, Australia, 4066
      • River City Pharmacy - APHS
    • Chermside, Queensland, Australia, 4032
      • Icon Cancer Care Chermside
    • Hope Island, Queensland, Australia, 4212
      • Gold Coast Radiology PTY LTD
    • South Brisbane, Queensland, Australia, 4101
      • Icon Cancer Care
    • South Brisbane, Queensland, Australia, 4101
      • Icon Cancer Care South Brisbane
    • Tugun, Queensland, Australia, 4224
      • South Coast Radiology
  • South Australia
    • Kurralta Park, South Australia, Australia, 5037
      • Ashford Cancer Centre Research
    • Kurralta Park, South Australia, Australia, 5037
      • Adelaide Cancer Centre
    • Kurralta Park, South Australia, Australia, 5037
      • Cancer Care SA Pty Ltd
    • Kurralta Park, South Australia, Australia, 5037
      • Tenpharm Pty Ltd trading as EPIC Pharmacy Tennyson
  • Victoria
    • Bentleigh East, Victoria, Australia, 3165
      • Moorabbin Radiology
    • Box Hill, Victoria, Australia, 3128
      • Box Hill Hospital
    • Clayton, Victoria, Australia, 3168
      • Monash Medical Centre
    • Malvern, Victoria, Australia, 3144
      • Cabrini Health - Cabrini Hospital
    • Wodonga, Victoria, Australia, 3690
      • Border Medical Oncology
• Belgium
  • Bruxelles, Belgium, 1200
    • Cliniques universitaires Saint-Luc
  • Leuven, Belgium, 3000
    • Universitaire Ziekenhuizen Leuven
  • West-vlaanderen
    • Kortrijk, West-vlaanderen, Belgium, 8500
      • Algemeen Ziekenhuis Groeninge
• Denmark
  • Arhus N, Denmark, 8200
    • Århus Universitetshospital
  • Copenhagen, Denmark, 2100
    • Rigshospitalet
  • Frederiksberg, Denmark, 2000
    • Frederiksberg hospital
  • Norrebro
    • Copenhagen, Norrebro, Denmark, 2200
      • Rigshospitalet CPC 7521
• Finland
  • Helsinki, Finland, 00290
    • Helsingin yliopistollinen keskussairaala, Meilahden sairaala
  • Oulu, Finland, 90220
    • Oulun Yliopistollinen sairaala
  • Tampere, Finland, 33520
    • Tampereen Yliopistollinen Sairaala
• France
  • Villejuif Cedex, France, 94805
    • Institut Gustave Roussy - Service d'Urologie
• Italy
  • Cremona, Italy, 26100
    • Struttura Complessa di Oncologia, Azienda Socio Sanitaria Territoriale di Cremona
  • Cremona, Italy, 26100
    • Medicina Nucleare, Azienda Ospedaliera "Istituti Ospitalieri" di Cremona
  • Cremona, Italy, 26100
    • Servizio di Radiologia, Azienda Ospedaliera "Istituti Ospitalieri" di Cremona
  • Meldola (FC), Italy, 47014
    • Laboratorio Farmaci Antiblastici
  • Meldola (FC), Italy, 47014
    • UO Radiologia
  • Orbassano TO, Italy, 10043
    • SCDU Oncologia Medica II Pad, A.O.U. San Luigi Gonzaga
  • Orbassano TO, Italy, 10043
    • SCDU Radiodiagnostica, A.O.U. San Luigi Gonzaga
  • Orbassano TO, Italy, 10043
    • SS Medicina Nucleare, A.O.U. San Luigi Gonzaga
  • Roma, Italy, 00152
    • Azienda Ospedaliera S. Camillo Forlanini, UOC per il governo clinico in Oncologia Medica
  • Roma, Italy, 00512
    • UOC Radiologia Piasta, Azienda Ospedaliera S. Camillo Forlanini
  • FC
    • Meldola, FC, Italy, 47014
      • U.O. Oncologia Medica, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura
• Slovakia
  • Banska Bystrica, Slovakia, 97517
    • Fakultna nemocnica s poliklinikou F.D. Roosevelta
  • Banska Bystrica, Slovakia, 975 17
    • Fakultna nemocnica s poliklinikou F.D. Roosevelta
  • Banska Bystrica, Slovakia, 975 17
    • Institut nuklearnej a molekularnej mediciny
  • Bratislava, Slovakia, 851 05
    • CUIMED, s.r.o., Urologicka ambulancia
  • Bratislava, Slovakia, 814 99
    • Bratislavske radiodiagnosticke centrum,a.s.
  • Martin, Slovakia, 036 59
    • Univerzitna Nemocnica Martin
  • Nitra, Slovakia, 949 01
    • Jessenius-diagnosticke centrum, a.s.
  • Nitra, Slovakia, 949 01
    • Uroexam, spol. s r.o., Urologicka ambulancia
  • Nitra, Slovakia, 950 01
    • IZOTOPCENTRUM, s.r.o.
  • Trnava, Slovakia, 917 01
    • GAMMALAB, spol.s r.o., Oddelenie nuklearnej mediciny
• Spain
  • Barcelona, Spain, 08003
    • Hospital Del Mar
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona
  • Madrid, Spain, 28050
    • Hospital Universitario Madrid Sanchinarro
  • Barcelon
    • Badalona,, Barcelon, Spain, 08916
      • ICO Badalona-Instituto Germans Trias i Pujol
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • CO Badalona-Instituto Germans Trias i Pujol
    • Badalona,, Barcelona, Spain, 08916
      • ICO Badalona-Instituto Germans Trias i Pujol
    • Manresa, Barcelona, Spain, 08243
      • ALTAHIA, Xarxa Assistencial Universitaria de Manresa
    • Sabadell, Barcelona, Spain, 08208
      • Hospital Universitari Parc Tauli
  • Islas Baleares
    • Palma, Islas Baleares, Spain, 07120
      • Hospital Universitario Son Espases
• Sweden
  • Goteborg, Sweden, 41345
    • Urologmottagningen
  • Malmo, Sweden, 20502
    • Urologiska Kliniken
  • Molnlycke, Sweden, 435 25
    • Oriola
  • Molnlycke, Sweden, 435 33
    • Apoteket AB Kliniska Provningar Molnlycke
  • Orebro, Sweden, 701 85
    • Rontgenkliniken
  • Orebro, Sweden, 701 85
    • Urologmottagningen
• United Kingdom
  • Cardiff, United Kingdom, CF14 2TL
    • Velindre NHS Trust
  • London, United Kingdom, SW3 6JJ
    • The Royal Marsden NHS Foundation Trust
  • London, United Kingdom, NW1 2BU
    • University College Hospitals NHS Trust
  • London, United Kingdom, WC1E 6AG
    • University College London Hospitals NHS Foundation Trust
  • Oxford, United Kingdom, OX3 7LE
    • Oxford University Hospitals NHS Trust
  • Middlesex
    • Northwood, Middlesex, United Kingdom, HA6 2RN
      • East and North Hertfordshire NHS Trust
  • Surrey
    • Sutton, Surrey, United Kingdom, SM2 5PT
      • The Royal Marsden NHS Foundation Trust
• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute
    • Boston, Massachusetts, United States, 02115
      • Brigham & Women's Hospital
    • Boston, Massachusetts, United States, 02115
      • Beth Israel Deaconess Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • eResearch Technology
  • Virginia
    • Virginia Beach, Virginia, United States, 23462
      • Urology of Virginia, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Enzalutamide; 160 mg by mouth once daily; Other Names: Xtandi; MDV3100; Drug: Abiraterone; 1000 mg by mouth once daily; Other Names: Zytiga; Abiraterone acetate; Drug: Prednisone; 5 mg by mouth twice daily; Other Names: prednisolone
Active Comparator: 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.	Drug: Abiraterone; 1000 mg by mouth once daily; Other Names: Zytiga; Abiraterone acetate; Drug: Prednisone; 5 mg by mouth twice daily; Other Names: prednisolone; Drug: Placebo for Enzalutamide; Sugar pill manufactured to mimic Enzalutamide 40 mg capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Pain Progression	Rate of pain progression was defined as percentage of participants with an increase of >=30% from baseline in the mean Brief Pain Inventory-Short Form (BPI-SF) pain intensity item scores of 4 items assessing average, worst, least, and intermediate pain severity. BPI-SF is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions of a participant. BPI-sf includes 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). BPI-sf score range for each item was from 0=no pain to 10=worst possible pain. Total score was reported as average of individual questions ranges from 0 to 10, where lower scores indicated less pain or less pain interference.	Month 6
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score	The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score which is the sum of all 5 domain scores and ranges from 0 to 156 where higher scores represent better quality of life.	Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores	The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for social/family well-being domain is from 0 (worst response) to 32 (best response), where higher score indicate better quality of life.	Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores	The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for emotional well-being domain is from 0 (worst response) to 24 (best response), where higher score indicate better quality of life.	Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores	The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for functional well-being domain is from 0 (worst response) to 28 (best response), where higher score indicate better quality of life.	Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores	The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for prostate cancer domain is from 0 (worst response) to 48 (best response), where higher score indicated better quality of life with fewer symptoms.	Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores	The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for physical well-being domain is from 0 (worst response) to 28 (best response), where higher score indicate better quality of life.	Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
Time to Prostate Specific Antigen (PSA) Progression	Time from date of randomization to the date of first confirmed PSA progression as per Prostate Cancer Clinical Trials Working Group 2 (PCWG2). For participant's whose PSA decreased at Week 13 after randomization, progression was defined as 25 percent (%) PSA increase relative to nadir or absolute increase of >=2 nanogram/milliliter (ng/mL) above nadir. Progression was confirmed if another assessment measured at least 3 weeks later met the criterion as well. For participant's whose PSA did not decrease at Week 13 after randomization, progression was defined as 25% PSA increase relative to baseline assessed 12 weeks after baseline. Participants who were not known to have had a PFS event at the analysis date were censored at last PSA assessment date prior to data cutoff date.	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	PSA response rate was defined as percentage of participants with >=30% and >=50% decrease in PSA from baseline at randomization to the maximal PSA response with a threshold of 30% and 50% respectively. PSA response was confirmed if another assessment measured at least 3 weeks later met the criterion as well.	From randomization until disease progression, last tumor assessment without disease progression, whichever occurred first (maximum up to 11.1 months)
Objective Response Rate (ORR)	Objective response rate as assessed by the investigator according to Response Evaluation Criteria in Solid Tumor version 1.1 (RECIST v1.1) was defined as 1) Percentage of participants with confirmed best overall complete response (CR) and partial response (PR); 2) Percentage of participants with CR, PR and stable disease (SD) for target lesions or non-progressive disease for non-target lesions. CR: Disappearance of all non-nodal target and non-target lesions, including target and non-target lymph nodes reduction to <10 millimeter (mm) in short axis. No new lesions and disappearance of all non-target lesions. PR: >= 30% decrease in sum of diameters of target lesions, compared to the sum at baseline. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions.	From randomization until CR or PR, whichever occurred first (maximum up to 21.3 months)
Time to First Use of New Antineoplastic Therapy for Prostate Cancer	It was defined as time from randomization to the date of first use of subsequent antineoplastic therapy for prostate cancer. For participants who had not started subsequent antineoplastic therapy as of data analysis cutoff date, the time to first use of subsequent antineoplastic therapy was censored at the date of last assessment.	From randomization until date of first use of any antineoplastic therapy (after last dose date of Period 2, maximum up to 22.3 months
Time to Degradation of the Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score	Time to degradation of FACT-P was defined as the time from randomization to first assessment with at least a 10-point decrease from baseline in the global FACT-P score for each participant. The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, and functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score which is the sum of all 5 domain scores and ranges from 0 to 156 with higher scores representing better quality of life. Participants with no score degradation at the time of analysis data cutoff were censored at the date of last assessment showing no degradation.	From randomization up to maximum of 18.4 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent are events between first dose of study drug and up to 30 days after last dose of study drug that were absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious.	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	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was response to a question answered by the investigator: 'Is the AE leading to study discontinuation or death?' as 'yes'.	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	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was response to a question answered by the investigator: 'Is the AE leading to study discontinuation or death?' as 'yes'.	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 Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)	Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to study drug was assessed by the investigator.	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)

Collaborators and Investigators

• Sponsor: Pfizer
• Collaborators: Astellas Pharma Inc; Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
• Investigators: Study Director: Medical Director, Medviation, Inc.; Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2013
• Primary Completion (Actual): November 15, 2016
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: November 18, 2013
• First Submitted That Met QC Criteria: November 21, 2013
• First Posted (Estimated): November 26, 2013

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: August 22, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Steroid Synthesis Inhibitors; Prednisolone; Prednisone; Abiraterone Acetate
• Other Study ID Numbers: MDV3100-10; 2013-000722-54 (EudraCT Number); C3431013 (Other Identifier: Alias Study Number); PLATO, C3431013 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.