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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: October 12, 2014
Last verified: October 2014
  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 ]

Estimated Enrollment: 500
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
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 53 Study Locations
Sponsors and Collaborators
Medivation, Inc.
Astellas Pharma Inc
  More Information

No publications provided

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: October 12, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Prednisone
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014