Trial record 3 of 63 for:    Medivation

Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer (PROSPER)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Medivation, Inc.
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Medivation, Inc.
ClinicalTrials.gov Identifier:
NCT02003924
First received: December 3, 2013
Last updated: June 19, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to assess the safety and efficacy of enzalutamide in patients with non metastatic prostate cancer.


Condition Intervention Phase
Nonmetastatic Castration-Resistant Prostate Cancer
Drug: Enzalutamide
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multinational, Phase 3, Randomized, Double Blind, Placebo Controlled, Efficacy and Safety Study of Enzalutamide in Patients With Nonmetastatic Castration Resistant Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Medivation, Inc.:

Primary Outcome Measures:
  • Metastasis Free Survival (MFS) [ Time Frame: ≥ 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: ≥ 16 weeks ] [ Designated as safety issue: No ]
  • Time to Pain Progression [ Time Frame: ≥ 16 weeks ] [ Designated as safety issue: No ]
  • Time to Opiate Use for Prostate Cancer Pain [ Time Frame: ≥ 16 weeks ] [ Designated as safety issue: No ]
  • Time to First Use of Cytotoxic Chemotherapy [ Time Frame: ≥ 16 weeks ] [ Designated as safety issue: No ]
  • Time to First Use of New Antineoplastic Therapy [ Time Frame: ≥ 16 weeks ] [ Designated as safety issue: No ]
  • Time to Prostate-Specific Antigen (PSA) Progression [ Time Frame: ≥ 16 weeks ] [ Designated as safety issue: No ]
  • FACT-P Global Score [ Time Frame: ≥ 16 weeks ] [ Designated as safety issue: No ]
  • Quality of Life as assessed by EQ-5D-5L and QLQ-PR25 [ Time Frame: ≥ 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 1560
Study Start Date: December 2013
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Placebo
Sugar pill manufactured to mimic Enzalutamide 40 mg capsule
Drug: Placebo
Sugar pill to mimic enzalutamide
Experimental: Enzalutamide
160 mg by mouth once daily
Drug: Enzalutamide
160 mg by mouth once daily
Other Names:
  • MDV3100
  • Xtandi

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell, or small cell features;
  • Ongoing androgen deprivation therapy with a GnRH agonist/antagonist or prior bilateral orchiectomy (medical or surgical castration);
  • Testosterone ≤ 50 ng/dL (≤ 1.73 nmol/L) at screening;
  • Progressive disease on androgen deprivation therapy at enrollment;
  • PSA and the screening PSA assessed by the central laboratory (central PSA) should be ≥ 2 µg/L (2 ng/mL:
  • PSA doubling time ≤ 10 months;
  • No prior or present evidence of metastatic disease;
  • Asymptomatic prostate cancer;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
  • Estimated life expectancy ≥ 12 months.

Exclusion Criteria:

  • Prior cytotoxic chemotherapy;
  • Use of hormonal therapy or biologic therapy for prostate cancer (other than approved bone targeting agents and GnRH agonist/antagonist therapy) or use of an investigational agent within 4 weeks of randomization;
  • Known or suspected brain metastasis or active leptomeningeal disease;
  • History of another invasive cancer within 3 years of randomization;
  • Absolute neutrophil count < 1000/μL, platelet count < 100,000/μL, or hemoglobin < 10 g/dL (6.2 mmol/L) at screening;
  • Total bilirubin ≥ 1.5 times the upper limit of normal;
  • Creatinine > 2 mg/dL (177 µmol/L) at screening;
  • Albumin < 3.0 g/dL (30 g/L) at screening;
  • History of seizure or any condition that may predispose to seizure;
  • Clinically significant cardiovascular disease;
  • Gastrointestinal disorder affecting absorption;
  • Major surgery within 4 weeks of randomization;
  • Hypersensitivity reaction to the active pharmaceutical ingredient or any of the capsule components, including Labrasol, butylated hydroxyanisole, and butylated hydroxytoluene;
  • Any concurrent disease, infection, or comorbid condition that interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of data, in the opinion of the investigator or medical monitor.
  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: NCT02003924

Contacts
Contact: Mohammad Hirmand, MD 415-543-3470 mohammad.hirmand@medivation.com
Contact: Kristina Wilson 415-543-3470 kristina.wilson@medivation.com

  Show 161 Study Locations
Sponsors and Collaborators
Medivation, Inc.
Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Medivation, Inc.
ClinicalTrials.gov Identifier: NCT02003924     History of Changes
Other Study ID Numbers: MDV3100-14
Study First Received: December 3, 2013
Last Updated: June 19, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 28, 2014