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: May 26, 2015
Last verified: May 2015
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: Enzalutamide
Drug: Bicalutamide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Medivation, Inc.:

Primary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]
  • Composite of Safety [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Safety will be assessed by adverse events (AEs), frequency of study drug discontinuation due to AEs, laboratory evaluations and vital signs


Enrollment: 396
Study Start Date: July 2012
Estimated Study Completion Date: June 2018
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Enzalutamide
Enzalutamide 160 mg/day orally
Drug: Enzalutamide
160 mg, daily, by mouth.
Other Names:
  • MDV3100
  • Xtandi
Active Comparator: Bicalutamide
50 mg/day orally
Drug: Bicalutamide
50 mg, daily, by mouth
Other Name: Casodex

Detailed Description:

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.

An open-label period has been added to the main protocol. Following study unblinding, study patients receiving enzalutamide or bicalutamide at the time of unblinding and qualifying patients randomized to bicalutamide who discontinued prior to unblinding will be offered the opportunity to receive open label enzalutamide treatment under this protocol.

  Eligibility

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

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.

Open-Label Treatment Period:

Inclusion Criteria:

  • Received randomized double blind treatment in MDV3100-09 as follows:

    • Randomized to enzalutamide and receiving enzalutamide at the time of study unblinding;
    • Randomized to bicalutamide and receiving bicalutamide at the time of study unblinding;
    • Randomized to bicalutamide and discontinued bicalutamide before study unblinding;
  • Willing to maintain androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) agonist/antagonist or has had a bilateral orchiectomy.

Exclusion Criteria:

  • Is currently or has taken commercially available enzalutamide (Xtandi) prior to participation in this open-label extension;
  • Discontinued enzalutamide during the double-blind portion of the study prior to unblinding;
  • Has any clinically significant cardiovascular, dermatologic, endocrine, gastrointestinal, hematologic, hepatic, infectious, metabolic, neurologic, psychiatric, psychologic, pulmonary, or renal disorder or any other condition, including excessive alcohol or drug abuse, or secondary malignancy, that may interfere with study participation in the opinion of the investigator or medical monitor;
  • Has a current or previously treated brain metastasis or leptomeningeal disease.
  • Has a history of seizure or any condition that may predispose to seizure (eg, prior cortical stroke or significant brain trauma).
  • Has a history of loss of consciousness or transient ischemic attack within 12 months of open label day 1.
  • Has taken cytotoxic chemotherapy or investigational therapy within 4 weeks before enrollment (open label day 1).
  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: NCT01664923

  Show 71 Study Locations
Sponsors and Collaborators
Medivation, Inc.
Astellas Pharma Inc
Investigators
Study Director: Fong Wang, MD, PhD Medivation, Inc.
  More Information

No publications provided

Responsible Party: Medivation, Inc.
ClinicalTrials.gov Identifier: NCT01664923     History of Changes
Other Study ID Numbers: MDV3100-09
Study First Received: August 10, 2012
Last Updated: May 26, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Medivation, Inc.:
prostate cancer
enzalutamide
MDV3100

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Bicalutamide
Androgen Antagonists
Antineoplastic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on August 27, 2015