Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients

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

Sponsors

Lead Sponsor: Pfizer

Collaborator: Astellas Pharma Inc
Medivation LLC, a wholly owned subsidiary of Pfizer Inc.

Source Pfizer
Brief Summary

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

Overall Status Active, not recruiting
Start Date October 22, 2013
Completion Date May 31, 2024
Primary Completion Date November 15, 2016
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Progression Free Survival (PFS) From randomization until disease progression, last tumor assessment without disease progression or death due to any cause, whichever occurred first (up to the data cutoff date [07 Oct 2016])
Secondary Outcome
Measure Time Frame
Time to Prostate Specific Antigen (PSA) Progression From randomization until disease progression, last tumor assessment without disease progression, whichever occurred first (up to the data cutoff date [07 Oct 2016])
Prostate Specific Antigen (PSA) Response Rate From randomization until disease progression, last tumor assessment without disease progression, whichever occurred first (up to the data cutoff date [07 Oct 2016])
Objective Response Rate (ORR) From randomization until CR or PR, whichever occurred first (up to the data cutoff date [07 Oct 2016])
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, up to the data cutoff date [07 Oct 2016])
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score 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 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 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 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 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 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 Degradation of the Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score From randomization up to data cutoff date (07 Oct 2016)
Enrollment 509
Condition
Intervention

Intervention Type: Drug

Intervention Name: Enzalutamide

Description: 160 mg by mouth once daily

Arm Group Label: Enzalutamide & Abiraterone/prednisone

Intervention Type: Drug

Intervention Name: Abiraterone

Description: 1000 mg by mouth once daily

Intervention Type: Drug

Intervention Name: Placebo for Enzalutamide

Description: Sugar pill manufactured to mimic Enzalutamide 40 mg capsule

Arm Group Label: Enzalutamide placebo & Abiraterone/prednisone

Intervention Type: Drug

Intervention Name: Prednisone

Description: 5 mg by mouth twice daily

Other Name: prednisolone

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

Gender: Male

Gender Based: Yes

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Location
Facility:
Beth Israel Deaconess Medical Center | Boston, Massachusetts, 02115, United States
Brigham & Women's Hospital | Boston, Massachusetts, 02115, United States
Dana Farber Cancer Institute | Boston, Massachusetts, 02215, United States
Urology of Virginia, PLLC | Virginia Beach, Virginia, 23462, United States
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
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
Pharmacy Department, The Tweed Hospital | 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
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
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 | Bruxelles, 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 Cedex, 94805, France
U.O. Oncologia Medica, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura | Meldola, FC, 47014, Italy
Farmacia, Azienda Ospedaliera "Istituti Ospitalieri" di Cremona | Cremona, 26100, Italy
Medicina Nucleare, Azienda Ospedaliera "Istituti Ospitalieri" di Cremona | Cremona, 26100, Italy
Servizio di Radiologia, Azienda Ospedaliera "Istituti Ospitalieri" di Cremona | Cremona, 26100, Italy
U.O di Oncologia-Presidio Ospedaliero di Cremona-Istituti Ospitalieri di Cremona | Cremona, 26100, Italy
Laboratorio Farmaci Antiblastici | Meldola (FC), 47014, Italy
UO Radiologia | Meldola (FC), 47014, Italy
Farmacia Ospedaliera, A.O.U. San Luigi Gonzaga | Orbassano TO, 10043, 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
Farmacia, Azienda Ospedaliera S. Camillo Forlanini | Roma, 00152, Italy
UOC Radiologia Piasta, Azienda Ospedaliera S. Camillo Forlanini | Roma, 00512, Italy
Fakultna nemocnica s poliklinikou F.D. Roosevelta | Banska Bystrica, 975 17, Slovakia
Institut nuklearnej a molekularnej mediciny | Banska Bystrica, 975 17, Slovakia
Fakultna nemocnica s poliklinikou F.D. Roosevelta | Banska 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
CO 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
Hospital Universitario Son Espases | Palma, Islas Baleares, 07120, Spain
Hospital del Mar | Barcelona, 08003, Spain
Hospital Clinic de Barcelona | Barcelona, 08036, Spain
Hospital Universitario Madrid Sanchinarro | Madrid, 28050, Spain
Urologmottagningen | Goteborg, 41345, Sweden
Urologiska kliniken | Malmo, 20502, Sweden
Oriola | Molnlycke, 435 25, Sweden
Apoteket AB Kliniska Provningar Molnlycke | Molnlycke, 435 33, Sweden
Rontgenkliniken | Orebro, 701 85, Sweden
Urologmottagningen | Orebro, 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
Location Countries

Australia

Belgium

Denmark

Finland

France

Italy

Slovakia

Spain

Sweden

United Kingdom

United States

Verification Date

September 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Enzalutamide & Abiraterone/prednisone

Type: Experimental

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

Label: Enzalutamide placebo & Abiraterone/prednisone

Type: Active Comparator

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.

Acronym PLATO
Patient Data Yes
Study Design Info

Allocation: Randomized

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov