A Study of Enzalutamide Versus Bicalutamide in Castrate Men With Metastatic Prostate Cancer

NCT01288911

Last updated date
Study Location
Site US1934
Homewood, Alabama, 35209, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Prostatic Neoplasms
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features

- Ongoing androgen deprivation therapy with a Luteinizing Hormone Receptor Hormone (LHRH) agonist or antagonist at a stable dose and schedule within 4 weeks of randomization or bilateral orchiectomy (i.e., surgical or medical castration)

- Metastatic disease documented by one of the following:

- At least two bone lesions on bone scan, or

- Soft tissue disease documented by computed tomography (CT)/ magnetic resonance imaging (MRI), or

- Unequivocal pelvic adenopathy short axis > 2.0 cm in diameter by CT/MRI

- Progressive disease at study entry defined as one or more of the following three criteria occurring in the setting of castrate levels of testosterone:

- Prostate Specific Antigen (PSA) progression defined by a minimum of three rising PSA levels with an interval of ≥ 1 week between each determination. The PSA value should be ≥ 2 µg/L (2 ng/mL);

- Soft tissue disease progression defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1;

- Bone disease progression defined by two or more new lesions on bone scan

- Asymptomatic or mildly symptomatic from prostate cancer (i.e. the score on the Brief Pain Inventory-Short Form (BPI-SF) Question #3 must be < 4); no use of opiate analgesics for prostate cancer-related pain currently or anytime within 4 weeks prior to randomization

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, including subjects with decreased performance status not attributed to progressive and symptomatic prostate cancer

- Estimated life expectancy of ≥ 12 months

- Able to swallow the study drug and comply with study requirements

- A male subject and his female spouse/partner who is of childbearing potential must use two acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at Screening and continuing throughout the study period, and for 3 months after final study drug administration. Two acceptable forms of birth control include:

1. Condom (barrier method of contraception), AND

2. In addition to a condom, one of the following acceptable forms of contraception is required:

- Established use of oral, injected or implanted hormonal methods of contraception.

- Placement of an intrauterine device (IUD) or intrauterine system (IUS).

- Barrier methods of contraception: Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.

- Tubal ligation for at least 6 months prior to Screening

- Vasectomy or other surgical castration at least 6 months prior to Screening

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Prior cytotoxic chemotherapy for prostate cancer


- Severe concurrent disease, infection, or comorbidity that would make the subject
inappropriate for enrollment


- Known or suspected brain and/or skull metastasis or active epidural disease


- History of another malignancy within the previous 5 years other than curatively
treated non-melanomatous skin cancer


- Current or prior treatment with estrogens and/or drugs with anti-androgenic properties
such as spironolactone > 50 mg/day, or progestational agents for the treatment of
prostate cancer within 6 months prior to randomization


- Current or prior use of ketoconazole for the treatment of prostate cancer


- Use of antiandrogens within 6 weeks prior to randomization


- Documented prior disease progression while receiving antiandrogens. Disease
progression defined as PSA progression, radiographic progression and/or clinical
deterioration.


- Current or prior treatment with 5-α reductase inhibitors or anabolic steroids within 6
months prior to randomization


- Prior use of systemic glucocorticoids (the equivalent of 10 mg of prednisone) within 3
months prior to randomization or expectation of their use during the study


- Radiation therapy to bone lesions or prostatic bed within 4 weeks prior to
randomization


- Major surgery within 2 months prior to randomization


- History of seizure including febrile seizure or any condition that may predispose to
seizure (e.g., prior stroke, brain arteriovenous malformation, head trauma with loss
of consciousness requiring hospitalization). Also, current or prior treatment with
anti-epileptic medications for the treatment of seizures or history of loss of
consciousness or transient ischemic attack within 12 months prior to randomization


- Clinically significant cardiovascular disease including myocardial infarction within
past six months or uncontrolled angina within past three months

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NCT01288911
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  4. Highland, California
  5. San Diego, California
  6. Denver, Colorado
  7. Middlebury, Connecticut
  8. Melrose Park, Illinois
  9. Springfield, Illinois
  10. Jeffersonville, Indiana
  11. West Des Moines, Iowa
  12. Kansas City, Kansas
  13. Baltimore, Maryland
  14. Bethesda, Maryland
  15. Ann Arbor, Michigan
  16. Grand Rapids, Michigan
  17. Minneapolis, Minnesota
  18. Billings, Montana
  19. Lawrenceville, New Jersey
  20. Poughkeepsie, New York
  21. Rochester, New York
  22. Staten Island, New York
  23. Chapel Hill, North Carolina
  24. Greensboro, North Carolina
  25. Cincinnati, Ohio
  26. Columbus, Ohio
  27. Bala-Cynwyd, Pennsylvania
  28. Lancaster, Pennsylvania
  29. Myrtle Beach, South Carolina
  30. Nashville, Tennessee
  31. Houston, Texas
  32. San Antonio, Texas
  33. Virginia Beach, Virginia
  34. Burien, Washington
  35. Wenatchee, Washington
  36. Milwaukee, Wisconsin
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  39. Kortrijk,
  40. Leuven,
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  42. Turnhout,
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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study of Enzalutamide Versus Bicalutamide in Castrate Men With Metastatic Prostate Cancer
Official Title  ICMJE A Randomized, Double-Blind, Phase II, Efficacy and Safety Study of MDV3100 Versus Bicalutamide in Castrate Men With Metastatic Prostate Cancer
Brief Summary The purpose of this study was to determine the efficacy and safety of oral enzalutamide compared to bicalutamide in castrate men with metastatic prostate cancer who have progressed while on Luteinizing Hormone Receptor Hormone (LHRH) agonist/antagonist or after receiving a bilateral orchiectomy.
Detailed Description An open-label period was added to the main protocol. Following unblinding at the end of the double-blind period and demonstration of a statistically significant advantage of enzalutamide over bicalutamide as assessed by the primary endpoint, all ongoing enzalutamide treated participants and ongoing or previous bicalutamide treated participants that met entry criteria were offered open-label enzalutamide at the discretion of the participant and study investigators.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Prostatic Neoplasms
Intervention  ICMJE
  • Drug: enzalutamide
    capsules
    Other Name: MDV3100
  • Drug: bicalutamide
    tablets
    Other Name: Casodex
Study Arms  ICMJE
  • Experimental: Enzalutamide
    Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
    Intervention: Drug: enzalutamide
  • Active Comparator: Bicalutamide
    Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
    Intervention: Drug: bicalutamide
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 17, 2013)
375
Original Estimated Enrollment  ICMJE
 (submitted: February 1, 2011)
370
Actual Study Completion Date  ICMJE November 8, 2017
Actual Primary Completion Date October 19, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
  • Ongoing androgen deprivation therapy with a Luteinizing Hormone Receptor Hormone (LHRH) agonist or antagonist at a stable dose and schedule within 4 weeks of randomization or bilateral orchiectomy (i.e., surgical or medical castration)
  • Metastatic disease documented by one of the following:

    • At least two bone lesions on bone scan, or
    • Soft tissue disease documented by computed tomography (CT)/ magnetic resonance imaging (MRI), or
    • Unequivocal pelvic adenopathy short axis > 2.0 cm in diameter by CT/MRI
  • Progressive disease at study entry defined as one or more of the following three criteria occurring in the setting of castrate levels of testosterone:

    • Prostate Specific Antigen (PSA) progression defined by a minimum of three rising PSA levels with an interval of ? 1 week between each determination. The PSA value should be ? 2 µg/L (2 ng/mL);
    • Soft tissue disease progression defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1;
    • Bone disease progression defined by two or more new lesions on bone scan
  • Asymptomatic or mildly symptomatic from prostate cancer (i.e. the score on the Brief Pain Inventory-Short Form (BPI-SF) Question #3 must be < 4); no use of opiate analgesics for prostate cancer-related pain currently or anytime within 4 weeks prior to randomization
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, including subjects with decreased performance status not attributed to progressive and symptomatic prostate cancer
  • Estimated life expectancy of ? 12 months
  • Able to swallow the study drug and comply with study requirements
  • A male subject and his female spouse/partner who is of childbearing potential must use two acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at Screening and continuing throughout the study period, and for 3 months after final study drug administration. Two acceptable forms of birth control include:

    1. Condom (barrier method of contraception), AND
    2. In addition to a condom, one of the following acceptable forms of contraception is required:

      • Established use of oral, injected or implanted hormonal methods of contraception.
      • Placement of an intrauterine device (IUD) or intrauterine system (IUS).
      • Barrier methods of contraception: Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
      • Tubal ligation for at least 6 months prior to Screening
      • Vasectomy or other surgical castration at least 6 months prior to Screening

Exclusion Criteria:

  • Prior cytotoxic chemotherapy for prostate cancer
  • Severe concurrent disease, infection, or comorbidity that would make the subject inappropriate for enrollment
  • Known or suspected brain and/or skull metastasis or active epidural disease
  • History of another malignancy within the previous 5 years other than curatively treated non-melanomatous skin cancer
  • Current or prior treatment with estrogens and/or drugs with anti-androgenic properties such as spironolactone > 50 mg/day, or progestational agents for the treatment of prostate cancer within 6 months prior to randomization
  • Current or prior use of ketoconazole for the treatment of prostate cancer
  • Use of antiandrogens within 6 weeks prior to randomization
  • Documented prior disease progression while receiving antiandrogens. Disease progression defined as PSA progression, radiographic progression and/or clinical deterioration.
  • Current or prior treatment with 5-? reductase inhibitors or anabolic steroids within 6 months prior to randomization
  • Prior use of systemic glucocorticoids (the equivalent of 10 mg of prednisone) within 3 months prior to randomization or expectation of their use during the study
  • Radiation therapy to bone lesions or prostatic bed within 4 weeks prior to randomization
  • Major surgery within 2 months prior to randomization
  • History of seizure including febrile seizure or any condition that may predispose to seizure (e.g., prior stroke, brain arteriovenous malformation, head trauma with loss of consciousness requiring hospitalization). Also, current or prior treatment with anti-epileptic medications for the treatment of seizures or history of loss of consciousness or transient ischemic attack within 12 months prior to randomization
  • Clinically significant cardiovascular disease including myocardial infarction within past six months or uncontrolled angina within past three months
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada,   Denmark,   France,   Germany,   Romania,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01288911
Other Study ID Numbers  ICMJE 9785-CL-0222
2010-021868-15 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
Supporting Materials:Study Protocol
Supporting Materials:Statistical Analysis Plan (SAP)
Supporting Materials:Clinical Study Report (CSR)
Time Frame:Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Access Criteria:Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
URL:https://www.clinicalstudydatarequest.com/
Responsible Party Astellas Pharma Inc
Study Sponsor  ICMJE Astellas Pharma Inc
Collaborators  ICMJE Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
Investigators  ICMJE
Principal Investigator:Principal InvestigatorCarolina Urologic Research Center
Study Director:Associate Medical Science DirectorAstellas Pharma Global Development
PRS Account Astellas Pharma Inc
Verification Date July 2019

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