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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01995513




Registration number
NCT01995513
Ethics application status
Date submitted
18/11/2013
Date registered
26/11/2013

Titles & IDs
Public title
Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients
Scientific 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
Secondary ID [1] 0 0
2013-000722-54
Secondary ID [2] 0 0
MDV3100-10
Universal Trial Number (UTN)
Trial acronym
PLATO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Enzalutamide
Treatment: Drugs - Abiraterone
Treatment: Drugs - Placebo for Enzalutamide
Treatment: Drugs - Prednisone

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

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.


Treatment: Drugs: Enzalutamide
160 mg by mouth once daily

Treatment: Drugs: Abiraterone
1000 mg by mouth once daily

Treatment: Drugs: Placebo for Enzalutamide
Sugar pill manufactured to mimic Enzalutamide 40 mg capsule

Treatment: Drugs: Prednisone
5 mg by mouth twice daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS)
Timepoint [1] 0 0
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 [1] 0 0
Time to Prostate Specific Antigen (PSA) Progression
Timepoint [1] 0 0
From randomization until disease progression, last tumor assessment without disease progression, whichever occurred first (maximum up to 11.1 months)
Secondary outcome [2] 0 0
Prostate Specific Antigen (PSA) Response Rate
Timepoint [2] 0 0
From randomization until disease progression, last tumor assessment without disease progression, whichever occurred first (maximum up to 11.1 months)
Secondary outcome [3] 0 0
Objective Response Rate (ORR)
Timepoint [3] 0 0
From randomization until CR or PR, whichever occurred first (maximum up to 21.3 months)
Secondary outcome [4] 0 0
Rate of Pain Progression
Timepoint [4] 0 0
Month 6
Secondary outcome [5] 0 0
Time to First Use of New Antineoplastic Therapy for Prostate Cancer
Timepoint [5] 0 0
From randomization until date of first use of any antineoplastic therapy (after last dose date of Period 2, maximum up to 22.3 months
Secondary outcome [6] 0 0
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
Timepoint [6] 0 0
Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
Secondary outcome [7] 0 0
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores
Timepoint [7] 0 0
Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
Secondary outcome [8] 0 0
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores
Timepoint [8] 0 0
Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
Secondary outcome [9] 0 0
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores
Timepoint [9] 0 0
Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
Secondary outcome [10] 0 0
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores
Timepoint [10] 0 0
Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
Secondary outcome [11] 0 0
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores
Timepoint [11] 0 0
Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
Secondary outcome [12] 0 0
Time to Degradation of the Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
Timepoint [12] 0 0
From randomization up to maximum of 18.4 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/10/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/08/2022
Sample size
Target
Accrual to date
Final
509
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Border Medical Oncology Research Unit - Albury
Recruitment hospital [2] 0 0
Ramsay Health Care Australia Pty Ltd - Albury
Recruitment hospital [3] 0 0
Regional Imaging Border - Albury
Recruitment hospital [4] 0 0
Terry White Chemist - Albury
Recruitment hospital [5] 0 0
Concord Cancer Centre, Medical Oncology Department - Concord
Recruitment hospital [6] 0 0
Concord Hospital Clinical Trials Pharmacy - Concord
Recruitment hospital [7] 0 0
Epic Pharmacy Lismore - Lismore
Recruitment hospital [8] 0 0
Macquarie University Hospital Pharmacy - North Ryde
Recruitment hospital [9] 0 0
Macquarie University - North Ryde
Recruitment hospital [10] 0 0
Epic Pharmacy Port Macquarie base hospital - Port Macquarie
Recruitment hospital [11] 0 0
Port Macquarie Base Hospital,North Coast Cancer Institute - Port Macquarie
Recruitment hospital [12] 0 0
North Shore Radiology and Nuclear Medicine - St Leonards
Recruitment hospital [13] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [14] 0 0
Sydney Adventist Hospital - Sydney
Recruitment hospital [15] 0 0
Northern NSW Local Health District - Tweed Heads
Recruitment hospital [16] 0 0
Queensland Diagnostic Imaging - Tweed Heads
Recruitment hospital [17] 0 0
Sydney Adventist Hospital - Wahroonga
Recruitment hospital [18] 0 0
Regional Imaging - West Albury
Recruitment hospital [19] 0 0
Westmead Hospital - Westmead
Recruitment hospital [20] 0 0
Icon Cancer Care Wesley - Auchenflower
Recruitment hospital [21] 0 0
River City Pharmacy - APHS - Auchenflower
Recruitment hospital [22] 0 0
Icon Cancer Care Chermside - Chermside
Recruitment hospital [23] 0 0
Gold Coast Radiology PTY LTD - Hope Island
Recruitment hospital [24] 0 0
Icon Cancer Care South Brisbane - South Brisbane
Recruitment hospital [25] 0 0
Icon Cancer Care - South Brisbane
Recruitment hospital [26] 0 0
South Coast Radiology - Tugun
Recruitment hospital [27] 0 0
Adelaide Cancer Centre - Kurralta Park
Recruitment hospital [28] 0 0
Ashford Cancer Centre Research - Kurralta Park
Recruitment hospital [29] 0 0
Cancer Care SA Pty Ltd - Kurralta Park
Recruitment hospital [30] 0 0
Tenpharm Pty Ltd trading as EPIC Pharmacy Tennyson - Kurralta Park
Recruitment hospital [31] 0 0
Moorabbin Radiology - Bentleigh East
Recruitment hospital [32] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [33] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [34] 0 0
Cabrini Health - Cabrini Hospital - Malvern
Recruitment hospital [35] 0 0
Border Medical Oncology - Wodonga
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
2480 - Lismore
Recruitment postcode(s) [4] 0 0
2109 - North Ryde
Recruitment postcode(s) [5] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [6] 0 0
2065 - St Leonards
Recruitment postcode(s) [7] 0 0
2076 - Sydney
Recruitment postcode(s) [8] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [9] 0 0
2076 - Wahroonga
Recruitment postcode(s) [10] 0 0
2640 - West Albury
Recruitment postcode(s) [11] 0 0
2145 - Westmead
Recruitment postcode(s) [12] 0 0
4066 - Auchenflower
Recruitment postcode(s) [13] 0 0
4032 - Chermside
Recruitment postcode(s) [14] 0 0
4212 - Hope Island
Recruitment postcode(s) [15] 0 0
4101 - South Brisbane
Recruitment postcode(s) [16] 0 0
4224 - Tugun
Recruitment postcode(s) [17] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [18] 0 0
3165 - Bentleigh East
Recruitment postcode(s) [19] 0 0
3128 - Box Hill
Recruitment postcode(s) [20] 0 0
3168 - Clayton
Recruitment postcode(s) [21] 0 0
3144 - Malvern
Recruitment postcode(s) [22] 0 0
3690 - Wodonga
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts
Country [2] 0 0
United States of America
State/province [2] 0 0
Pennsylvania
Country [3] 0 0
United States of America
State/province [3] 0 0
Virginia
Country [4] 0 0
Belgium
State/province [4] 0 0
West-vlaanderen
Country [5] 0 0
Belgium
State/province [5] 0 0
Bruxelles
Country [6] 0 0
Belgium
State/province [6] 0 0
Leuven
Country [7] 0 0
Denmark
State/province [7] 0 0
Norrebro
Country [8] 0 0
Denmark
State/province [8] 0 0
Arhus N
Country [9] 0 0
Denmark
State/province [9] 0 0
Copenhagen
Country [10] 0 0
Denmark
State/province [10] 0 0
Frederiksberg
Country [11] 0 0
Finland
State/province [11] 0 0
Helsinki
Country [12] 0 0
Finland
State/province [12] 0 0
Oulu
Country [13] 0 0
Finland
State/province [13] 0 0
Tampere
Country [14] 0 0
France
State/province [14] 0 0
Villejuif Cedex
Country [15] 0 0
Italy
State/province [15] 0 0
FC
Country [16] 0 0
Italy
State/province [16] 0 0
Cremona
Country [17] 0 0
Italy
State/province [17] 0 0
Meldola (FC)
Country [18] 0 0
Italy
State/province [18] 0 0
Orbassano TO
Country [19] 0 0
Italy
State/province [19] 0 0
Roma
Country [20] 0 0
Slovakia
State/province [20] 0 0
Banska Bystrica
Country [21] 0 0
Slovakia
State/province [21] 0 0
Bratislava
Country [22] 0 0
Slovakia
State/province [22] 0 0
Martin
Country [23] 0 0
Slovakia
State/province [23] 0 0
Nitra
Country [24] 0 0
Slovakia
State/province [24] 0 0
Trnava
Country [25] 0 0
Spain
State/province [25] 0 0
Barcelona
Country [26] 0 0
Spain
State/province [26] 0 0
Barcelon
Country [27] 0 0
Spain
State/province [27] 0 0
Islas Baleares
Country [28] 0 0
Spain
State/province [28] 0 0
Madrid
Country [29] 0 0
Sweden
State/province [29] 0 0
Goteborg
Country [30] 0 0
Sweden
State/province [30] 0 0
Malmo
Country [31] 0 0
Sweden
State/province [31] 0 0
Molnlycke
Country [32] 0 0
Sweden
State/province [32] 0 0
Orebro
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Middlesex
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Surrey
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Cardiff
Country [36] 0 0
United Kingdom
State/province [36] 0 0
London
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Astellas Pharma Inc
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT01995513