Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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 March 2017 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: April 7, 2017
Last verified: March 2017
  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
Prostate Cancer
Cancer of the Prostate
Drug: Enzalutamide
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: ≥ 16 weeks ]
  • Time to Pain Progression [ Time Frame: ≥ 16 weeks ]
  • Time to Opiate Use for Prostate Cancer Pain [ Time Frame: ≥ 16 weeks ]
  • Time to First Use of Cytotoxic Chemotherapy [ Time Frame: ≥ 16 weeks ]
  • Time to First Use of New Antineoplastic Therapy [ Time Frame: ≥ 16 weeks ]
  • Time to Prostate-Specific Antigen (PSA) Progression [ Time Frame: ≥ 16 weeks ]
  • FACT-P Global Score [ Time Frame: ≥ 16 weeks ]
  • Quality of Life as assessed by EQ-5D-5L and QLQ-PR25 [ Time Frame: ≥ 16 weeks ]

Estimated Enrollment: 1560
Study Start Date: December 2013
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: June 2019 (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   (Adult, Senior)
Sexes 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 gonadotropin-releasing hormone (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: Medivation Clinical Operations +1 (415) 543-3470
Contact: Medivation Clinical Trial Disclosure TrialDisclosure@Medivation.com

  Show 289 Study Locations
Sponsors and Collaborators
Medivation, Inc.
Astellas Pharma Inc
Investigators
Study Director: Medical Director Medivation, Inc.
  More Information

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: April 7, 2017

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 April 21, 2017