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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Astellas Pharma Inc
Medivation, Inc.
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT02003924
First received: December 3, 2013
Last updated: July 13, 2017
Last verified: July 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 Pfizer:

Primary Outcome Measures:
  • Metastasis Free Survival (MFS) [ Time Frame: ≥ 16 weeks ]

Secondary Outcome Measures:
  • Time to Prostate-Specific Antigen (PSA) Progression [ Time Frame: ≥ 16 weeks ]
  • Time to First Use of New Antineoplastic Therapy [ Time Frame: ≥ 16 weeks ]
  • Overall Survival (OS) [ Time Frame: ≥ 16 weeks ]
  • Time to First Use of Cytotoxic Chemotherapy [ 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 ]
  • Time to chemotherapy-free disease specific survival [ Time Frame: ≥ 16 weeks ]
  • Time to chemotherapy-free survival [ Time Frame: ≥ 16 weeks ]
  • Time to pain progression [ Time Frame: ≥ 16 weeks ]
  • Safety as assessed by percentage of patients with any Adverse Event (AE), AE leading to Study Drug Discontinuation, AE leading to death, Serious Adverse Event (SAE), AE related to study drug, SAE related to study drug [ Time Frame: ≥ 16 weeks ]
  • PSA response rates [ Time Frame: ≥ 16 weeks ]

Estimated Enrollment: 1440
Study Start Date: December 2013
Estimated Study Completion Date: May 2020
Primary Completion Date: June 2017 (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

  Show 287 Study Locations
Sponsors and Collaborators
Pfizer
Astellas Pharma Inc
Medivation, Inc.
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02003924     History of Changes
Other Study ID Numbers: MDV3100-14
Study First Received: December 3, 2013
Last Updated: July 13, 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 July 26, 2017