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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Medivation, Inc.
ClinicalTrials.gov Identifier:
NCT01995513
First received: November 18, 2013
Last updated: February 16, 2016
Last verified: February 2016
  Purpose
The purpose of this study is to determine if continued treatment with Enzalutamide is effective in patients with metastatic prostate cancer.

Condition Intervention Phase
Prostate Cancer
Drug: Enzalutamide
Drug: Abiraterone
Drug: Placebo for Enzalutamide
Drug: Prednisone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Medivation, Inc.:

Primary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: Every two months following randomization for up to 50 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to PSA Progression [ Time Frame: Every two months following randomization for up to 50 months ] [ Designated as safety issue: No ]
  • PSA Response [ Time Frame: Every two months following randomization for up to 50 months ] [ Designated as safety issue: No ]

Enrollment: 509
Study Start Date: November 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Enzalutamide & Abiraterone
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:
  • MDV3100
  • Xtandi
Drug: Abiraterone
1000 mg by mouth once daily
Other Names:
  • Abiraterone acetate
  • Zytiga
Drug: Prednisone
5 mg by mouth twice daily
Other Name: prednisolone
Active Comparator: Enzalutamide placebo & Abiraterone
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:
  • Abiraterone acetate
  • Zytiga
Drug: Placebo for Enzalutamide
Sugar pill manufactured to mimic Enzalutamide 40 mg capsule
Drug: Prednisone
5 mg by mouth twice daily
Other Name: prednisolone

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01995513

  Show 52 Study Locations
Sponsors and Collaborators
Medivation, Inc.
Astellas Pharma Inc
Investigators
Study Director: Medical Director Medviation, Inc.
  More Information

Responsible Party: Medivation, Inc.
ClinicalTrials.gov Identifier: NCT01995513     History of Changes
Other Study ID Numbers: MDV3100-10 
Study First Received: November 18, 2013
Last Updated: February 16, 2016
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Denmark: Danish Health and Medicines Authority
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Italy: The Italian Medicines Agency
Slovakia: State Institute for Drug Control
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Prednisone
Abiraterone Acetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Cytochrome P-450 Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 24, 2016