Safety and Efficacy Study of Enzalutamide Versus Bicalutamide in Men With Prostate Cancer (STRIVE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Medivation, Inc.
ClinicalTrials.gov Identifier:
NCT01664923
First received: August 10, 2012
Last updated: March 24, 2014
Last verified: March 2014

August 10, 2012
March 24, 2014
July 2012
June 2015   (final data collection date for primary outcome measure)
Progression Free Survival (PFS) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01664923 on ClinicalTrials.gov Archive Site
  • Time to Prostate Specific Antigen (PSA) Progression [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • PSA Response [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
  • Time to Radiographic Progression [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Functional Assessment of Cancer Therapy - Prostate (FACT-P) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Safety assess by AEs, frequency of study drug discontinuation due to AEs, laboratory evaluations and vital signs
  • Time to Prostate Specific Antigen (PSA) Progression [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • PSA Response [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
  • Time to Radiographic Progression [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
  • Functional Assessment of Cancer Therapy - Prostate (FACT-P) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Safety assess by AEs, frequency of study drug discontinuation due to AEs, laboratory evaluations and vital signs
Not Provided
Not Provided
 
Safety and Efficacy Study of Enzalutamide Versus Bicalutamide in Men With Prostate Cancer
A Multicenter Phase 2, Randomized, Double-Blind, Efficacy and Safety Study of Enzalutamide Versus Bicalutamide in Men With Prostate Cancer Who Have Failed Primary Androgen Deprivation Therapy

The purpose of this study is to determine the safety and efficacy of enzalutamide vs. bicalutamide in asymptomatic or mildly symptomatic patients with prostate cancer who have disease progression despite primary androgen deprivation therapy.

This study is a multicenter Phase 2, randomized, double-blind, efficacy and safety study of enzalutamide (160 mg/day) vs. bicalutamide (50 mg/day) in patients with recurrent prostate cancer who have serologic and/or radiographic disease progression despite primary androgen deprivation therapy.

Throughout the study, safety and tolerability will be assessed by the recording of adverse events, monitoring of vital signs, physical examinations, and safety laboratory evaluations.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Prostate Cancer
  • Drug: Enzalutamide
    160 mg, daily, by mouth.
    Other Name: MDV3100
  • Drug: Bicalutamide
    50 mg, daily, by mouth
    Other Name: Casodex
  • Experimental: Enzalutamide
    Enzalutamide 160 mg/day orally
    Intervention: Drug: Enzalutamide
  • Active Comparator: Bicalutamide
    50 mg/day orally
    Intervention: Drug: Bicalutamide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
400
June 2015
June 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males age 18 or older;
  • Histologically or cytologically confirmed adenocarcinoma of the prostate;
  • Ongoing androgen deprivation therapy
  • Serum testosterone level ≤ 50 ng/dL (1.73 nmol/L) at the Screening visit;
  • Progressive disease at study entry defined by PSA progression and/or radiographic progression that occurred while the patient was on primary androgen deprivation therapy
  • Asymptomatic or mildly symptomatic from prostate cancer;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
  • Estimated life expectancy of ≥ 12 months;
  • Able to swallow the study drug and comply with study requirements.

Exclusion Criteria:

  • Severe concurrent disease, infection, or co-morbidity;
  • Known or suspected brain metastasis or active leptomeningeal disease;
  • History of another invasive malignancy within the previous 5 years other than curatively treated non-melanomatous skin cancer and American Joint Committee on Cancer (AJCC) Stage 0 or Stage 1 cancers that have a remote probability of recurrence;
  • Absolute neutrophil count < 1,500/µL, or platelet count < 100,000/µL, or hemoglobin < 9 g/dL at the Screening visit;
  • Total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 times the upper limit of normal (ULN) at the Screening visit;
  • Creatinine > 2 mg/dL at the Screening visit;
  • Albumin < 3.0 g/dL at the Screening visit;
  • History of seizure or any condition that may predispose to seizure;
  • Clinically significant cardiovascular disease;
  • Gastrointestinal disorder affecting absorption (e.g., gastrectomy, active peptic ulcer disease within last 3 months);
  • Major surgery within 4 weeks of enrollment;
  • Use of opiate analgesics for pain from prostate cancer within 4 weeks of enrollment;
  • Radiation therapy for treatment of the primary tumor within 3 weeks of enrollment;
  • Prior radiation or radionuclide therapy for treatment of distant metastases;
  • Prior ketoconazole, abiraterone, or cytotoxic chemotherapy for prostate cancer;
  • Treatment with hormonal therapy or biologic therapy for prostate cancer within 4 weeks of enrollment.
  • Use of antiandrogens within 4 weeks prior to enrollment;
  • Prior disease progression, as assessed by the Investigator, while receiving bicalutamide;
  • Participation in a previous clinical trial of enzalutamide or an investigational agent that inhibits the androgen receptor or androgen synthesis (patients who received placebo are acceptable);
  • Use of an investigational agent within 4 weeks of enrollment;
  • Use of herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g., saw palmetto) or systemic corticosteroids for prostate cancer within 4 weeks of enrollment;
  • Any condition or reason that, in the opinion of the Investigator, interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of safety data.
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01664923
MDV3100-09
Not Provided
Medivation, Inc.
Medivation, Inc.
Astellas Pharma Inc
Study Director: Fong Wang, MD, PhD Medivation, Inc.
Medivation, Inc.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP