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Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients (PLATO)

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Enzalutamide
Abiraterone
Placebo for Enzalutamide
Prednisone
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Beth Israel Deaconess Medical Center
  • Brigham & Women's Hospital
  • Beth Israel Deaconess Medical Center
  • Dana Farber Cancer Institute
  • eResearch Technology
  • Urology of Virginia, PLLC
  • Border Medical Oncology Research Unit
  • Ramsay Health Care Australia Pty Ltd
  • Regional Imaging Border
  • Terry White Chemist
  • Concord Cancer Centre, Medical Oncology Department
  • Concord Hospital Clinical Trials Pharmacy
  • Epic Pharmacy Lismore
  • Macquarie University Hospital Pharmacy
  • Macquarie University
  • Epic Pharmacy Port Macquarie base hospital
  • Port Macquarie Base Hospital,North Coast Cancer Institute
  • North Shore Radiology and Nuclear Medicine
  • Royal North Shore Hospital
  • Sydney Adventist Hospital
  • Northern NSW Local Health District
  • Queensland Diagnostic Imaging
  • Sydney Adventist Hospital
  • Regional Imaging
  • Westmead Hospital
  • Icon Cancer Care Wesley
  • River City Pharmacy - APHS
  • Icon Cancer Care Chermside
  • Gold Coast Radiology PTY LTD
  • Icon Cancer Care South Brisbane
  • Icon Cancer Care
  • South Coast Radiology
  • Adelaide Cancer Centre
  • Ashford Cancer Centre Research
  • Cancer Care SA Pty Ltd
  • Tenpharm Pty Ltd trading as EPIC Pharmacy Tennyson
  • Moorabbin Radiology
  • Box Hill Hospital
  • Monash Medical Centre
  • Cabrini Health - Cabrini Hospital
  • Border Medical Oncology
  • Algemeen Ziekenhuis Groeninge
  • Cliniques universitaires saint-Luc
  • Universitaire Ziekenhuizen Leuven
  • Rigshospitalet CPC 7521
  • Arhus Universitetshospital
  • Rigshospitalet
  • Frederiksberg Hospital
  • Helsingin yliopistollinen keskussairaala, Meilahden sairaala
  • Oulun yliopistollinen sairaala
  • Tampereen yliopistollinen Sairaala
  • Institut Gustave Roussy - Service d'Urologie
  • U.O. Oncologia Medica, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura
  • Medicina Nucleare, Azienda Ospedaliera "Istituti Ospitalieri" di Cremona
  • Servizio di Radiologia, Azienda Ospedaliera "Istituti Ospitalieri" di Cremona
  • Struttura Complessa di Oncologia, Azienda Socio Sanitaria Territoriale di Cremona
  • Laboratorio Farmaci Antiblastici
  • UO Radiologia
  • SCDU Oncologia Medica II Pad, A.O.U. San Luigi Gonzaga
  • SCDU Radiodiagnostica, A.O.U. San Luigi Gonzaga
  • SS Medicina Nucleare, A.O.U. San Luigi Gonzaga
  • Azienda Ospedaliera S. Camillo Forlanini, UOC per il governo clinico in Oncologia Medica
  • UOC Radiologia Piasta, Azienda Ospedaliera S. Camillo Forlanini
  • Fakultna nemocnica s poliklinikou F.D. Roosevelta
  • Institut nuklearnej a molekularnej mediciny
  • Fakultna nemocnica s poliklinikou F.D. Roosevelta
  • Bratislavske radiodiagnosticke centrum,a.s.
  • CUIMED, s.r.o., urologicka ambulancia
  • Univerzitna nemocnica martin
  • Jessenius-diagnosticke centrum, a.s.
  • Uroexam, spol. s r.o., Urologicka ambulancia
  • IZOTOPCENTRUM, s.r.o.
  • GAMMALAB, spol.s r.o., Oddelenie nuklearnej mediciny
  • ICO Badalona-Instituto Germans Trias i Pujol
  • CO Badalona-Instituto Germans Trias i Pujol
  • ALTAHIA, Xarxa Assistencial Universitaria de Manresa
  • Hospital Universitari Parc Tauli
  • ICO Badalona-Instituto Germans Trias i Pujol
  • Hospital Universitario Son Espases
  • Hospital del Mar
  • Hospital Clinic de Barcelona
  • Hospital Universitario Madrid Sanchinarro
  • Urologmottagningen
  • Urologiska kliniken
  • Oriola
  • Apoteket AB Kliniska Provningar Molnlycke
  • Rontgenkliniken
  • Urologmottagningen
  • East and North Hertfordshire NHS Trust
  • The Royal Marsden NHS Foundation Trust
  • Velindre NHS Trust
  • University College Hospitals NHS Trust
  • The Royal Marsden NHS Foundation Trust
  • University College London Hospitals NHS Foundation Trust
  • Oxford University Hospitals NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Enzalutamide & Abiraterone/prednisone

Enzalutamide placebo & Abiraterone/prednisone

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
November 18, 2013
Last Updated
August 22, 2023
Sponsor
Pfizer
Collaborators
Astellas Pharma Inc, Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01995513
Brief Title
Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients
Acronym
PLATO
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
October 22, 2013 (Actual)
Primary Completion Date
November 15, 2016 (Actual)
Study Completion Date
August 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
Collaborators
Astellas Pharma Inc, Medivation LLC, a wholly owned subsidiary of Pfizer Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
509 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enzalutamide & Abiraterone/prednisone
Arm Type
Experimental
Arm Description
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
Arm Title
Enzalutamide placebo & Abiraterone/prednisone
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Enzalutamide
Other Intervention Name(s)
MDV3100, Xtandi
Intervention Description
160 mg by mouth once daily
Intervention Type
Drug
Intervention Name(s)
Abiraterone
Other Intervention Name(s)
Abiraterone acetate, Zytiga
Intervention Description
1000 mg by mouth once daily
Intervention Type
Drug
Intervention Name(s)
Placebo for Enzalutamide
Intervention Description
Sugar pill manufactured to mimic Enzalutamide 40 mg capsule
Intervention Type
Drug
Intervention Name(s)
Prednisone
Other Intervention Name(s)
prednisolone
Intervention Description
5 mg by mouth twice daily
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
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.
Time Frame
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 Measure Information:
Title
Time to Prostate Specific Antigen (PSA) Progression
Description
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.
Time Frame
From randomization until disease progression, last tumor assessment without disease progression, whichever occurred first (maximum up to 11.1 months)
Title
Prostate Specific Antigen (PSA) Response Rate
Description
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.
Time Frame
From randomization until disease progression, last tumor assessment without disease progression, whichever occurred first (maximum up to 11.1 months)
Title
Objective Response Rate (ORR)
Description
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.
Time Frame
From randomization until CR or PR, whichever occurred first (maximum up to 21.3 months)
Title
Rate of Pain Progression
Description
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.
Time Frame
Month 6
Title
Time to First Use of New Antineoplastic Therapy for Prostate Cancer
Description
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.
Time Frame
From randomization until date of first use of any antineoplastic therapy (after last dose date of Period 2, maximum up to 22.3 months
Title
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
Description
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.
Time Frame
Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
Title
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores
Description
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.
Time Frame
Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
Title
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores
Description
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.
Time Frame
Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
Title
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores
Description
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.
Time Frame
Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
Title
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores
Description
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.
Time Frame
Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
Title
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores
Description
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.
Time Frame
Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
Title
Time to Degradation of the Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
Description
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.
Time Frame
From randomization up to maximum of 18.4 months
Other Pre-specified Outcome Measures:
Title
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
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.
Time Frame
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)
Title
Percentage of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation
Description
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'.
Time Frame
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)
Title
Percentage of Participants With Adverse Events (AEs) Leading to Death
Description
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'.
Time Frame
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)
Title
Percentage of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
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.
Time Frame
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)

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Citations:
PubMed Identifier
30028657
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.
Results Reference
derived

Learn more about this trial

Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients

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