A Study of MDV3100 Versus Bicalutamide in Castrate Men With Metastatic Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Medivation, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01288911
First received: February 1, 2011
Last updated: August 7, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to determine the efficacy and safety of oral MDV3100 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.


Condition Intervention Phase
Prostatic Neoplasms
Drug: MDV3100
Drug: Bicalutamide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Phase II, Efficacy and Safety Study of MDV3100 Versus Bicalutamide in Castrate Men With Metastatic Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

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

Secondary Outcome Measures:
  • Prostate Specific Antigen (PSA) response [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
  • Time to Prostate Specific Antigen (PSA) progression [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Safety assessed by recording adverse events, laboratory assessments, vital signs, physical examinations and electrocardiograms (ECGs) [ Time Frame: 33 months ] [ Designated as safety issue: No ]

Enrollment: 375
Study Start Date: February 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MDV3100 Drug: MDV3100
oral
Other Name: enzalutamide
Active Comparator: Bicalutamide Drug: Bicalutamide
oral
Other Name: Casodex

Detailed Description:

An open-label period has been 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 subjects and ongoing or previous bicalutamide treated subjects that meet entry criteria will be offered open-label enzalutamide at the discretion of the subject and study investigators.

  Eligibility

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

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 computed tomography (CT)/ magnetic resonance imaging (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-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
  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: NCT01288911

  Hide Study Locations
Locations
United States, Alabama
Urology Centers of Alabama, PC
Birmingham, Alabama, United States, 35209
United States, Alaska
Alaska Clinical Research Center, LLC
Anchorage, Alaska, United States, 99508
United States, Arizona
Urology Associates of Southern Arizona
Tucson, Arizona, United States, 85741
United States, California
Beaver Medical Group
Highland, California, United States, 92346
Tower Urology, Cedar Sinai Office Towers
Los Angeles, California, United States, 90048
Genesis Research
San Diego, California, United States, 92123
United States, Colorado
The Urology Center of Colorado
Denver, Colorado, United States, 80211
United States, Connecticut
Connecticut Clinical Research Center, LLC
Middlebury, Connecticut, United States, 06762
United States, Florida
Florida Urology Physicians
Fort Meyers, Florida, United States, 33908
Malcom Randal VAMC
Gainesville, Florida, United States, 32608
United States, Georgia
Urology Enterprises, PC
Marietta, Georgia, United States, 30060
United States, Illinois
UroPartners/RMD Clinical Research
Melrose Park, Illinois, United States, 60160
Springfield Clinic
Springfield, Illinois, United States, 62703
United States, Indiana
Northeast Indiana Research, LLC
Fort Wayne, Indiana, United States, 46825
Metropolitan Urology Clinical Research
Jeffersonville, Indiana, United States, 47130
United States, Iowa
The Iowa Clinic
West Desmoines, Iowa, United States, 50266
United States, Kansas
University of Kansas Medical Center
Westwood, Kansas, United States, 66205
United States, Maryland
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
Myron I. Murdock MD, LLC
Greenbelt, Maryland, United States, 20770
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
Spectrum Health Medical Group
Grand Rapids, Michigan, United States, 69546
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Montana
Billings Clinic Cancer Center
Billings, Montana, United States, 59101
United States, New Jersey
Premier Urology Associates, LLC / AdvanceMed Research
Lawrenceville, New Jersey, United States, 08648
United States, New York
University Urology Associates
New York City, New York, United States, 10016
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, United States, 12601
University of Rochester Medical Center
Rochester, New York, United States, 14642
Staten Island Urological Research, PC
Staten Island, New York, United States, 10304
United States, North Carolina
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Alliance Urology Specialists, PA
Greensboro, North Carolina, United States, 27403
Rex Cancer Center
Raleigh, North Carolina, United States, 27607
United States, Ohio
Division of Urology
Cincinnati, Ohio, United States, 45267
Columbus Urology Research, LLC
Columbus, Ohio, United States, 43220
United States, Pennsylvania
Urology Consultants of Southeastern Pennsylvania
Bala Cynwyd, Pennsylvania, United States, 19444
Urological Associates of Lancaster
Lancaster, Pennsylvania, United States, 17604
United States, South Carolina
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
United States, Tennessee
Urology Associates, PC
Nashville, Tennessee, United States, 37209
United States, Texas
Urology San Antonio Research, PA
San Antonio, Texas, United States, 78229
United States, Virginia
Urology of Virginia, Sentara Medical Group
Norfolk, Virginia, United States, 23502
United States, Washington
Seattle Urology Research Center
Burien, Washington, United States, 98166
Wenatchee Valley Medical Center
Wenatchee, Washington, United States, 98801
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Belgium
University Ziekenhuis
Brussel, BE, Belgium, 1090
UZ Leuven
Leuven, Brabant, Belgium, 3000
AZ Stuivenberg
Antwerp, Belgium, 2060
University Hospital Gent
Gent, Belgium, 9000
CHU de Liege
Liege, Belgium, 4000
AZ Turnhout Dienst Urologie
Turnhout, Belgium, 2300
Burgemeester Vercruysselaan
West Flanders, Belgium, 8500
Canada, Alberta
Prostate Cancer Centre
Calgary, Alberta, Canada, T2V 1P9
Canada, British Columbia
Exdeo Clinical Research, Inc
Abbotsford, British Columbia, Canada, V2S 3N6
Canada, Ontario
Centre for Applied Urological Research, Queen's University
Kingston, Ontario, Canada, K7L 3J7
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada, M4N 3M5
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Theradev Clinical Research
Granby, Quebec, Canada, J2G 8Z9
MUHC- Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
The Urology Specialists
Montreal, Quebec, Canada, H2X 1N8
Denmark
Urologisk Afdeling
Aalborg, Denmark, 9000
Aarhus University Hospital
Aarhus, Denmark, 8200
Rigshospitalet
Copenhagen, Denmark, 2200
Herlev Urologisk AFD. H
Herlev, Denmark, 2730
France
CHU Henri Mondor
Creteil, France, 94010
Hopital Claude Huriez
Lille Cedex, France, 59037
Hopital Edouard Herriot
Lyon Cedex 3, France, 69437
Hopital TENON
Paris, France, 75020
Centre Hospitalier Universitaire La Miletrie
Poitiers Cedex, France, 86021
CHU de Pontchaillou-CIC
Rennes Cedex, France, 35033
CHU Rouen
Rouen, France, 76031
Clinique Mutualiste
St. Etienne Cedex 2, France, 42013
Hopital Nord
St. Etienne Cedex 2, France, 42055
Hospital Foch
Suresnes Cedex, France, 92151
Germany
Aachen University
Aachen, Germany, 51074
Urologie Bonn Rhein-Sieg
Bonn, Germany, 53117
Bonn University
Bonn, Germany, 53105
Medizinisches Zentrum Bonn
Bonn, Germany, 53111
Marienkrankenhaus GmbH
Gladbach, Germany, 51465
Urologikum Hamburg, Medizinzentrum Hammoniabad
Hamburg, Germany, 22081
University Hannover
Hannover, Germany, 30625
Studienpraxis Urologie
Nurtingen, Germany, D-72622
Praxis Dres. Maier Loffler / Schradin
Reutlingen, Germany, 72764
Urologie am Hochrhein
Waldshut-Tiengen, Germany, 79761
Die Gesundheitsunion
Wuppertal, Germany, 42103
Romania
Institutul Fundeni
Bucharest, Romania, 022328
Spitalul Clinic
Bucharest, Romania, 50659
Societatea Civila Medicala Dinu Uromedica
Bucharest, Romania, 41345
United Kingdom
The Northern Ireland Cancer Trials Centre
Belfast, United Kingdom, BT9 7A
Bristol Royal Infirmary Hospital
Bristol, United Kingdom, BS2 8NW
Addenbrooke's Hospital
Cambridgeshire, United Kingdom, CB2 0QQ
University Hospital of Wales
Cardiff, United Kingdom, CF14 4XW
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom, G12 0YN
Rosemere Cancer Centre
Lancashire, United Kingdom, PR2 9HT
Leicester General Hospital
Leicester, United Kingdom, LE3 4PW
Guy's Hospital
London, United Kingdom, SE1 9RT
St. Georges Hospital NHS Trust
London, United Kingdom, SW17 0QT
Mount Vernon Cancer Centre
London, United Kingdom, HA6 2RN
University College Hospital London
London, United Kingdom, NW1 2PG
The Christie Hospital
Manchester, United Kingdom, M20 4BX
Clatterbridge Centre for Oncology
Wirral, United Kingdom, CH63 4JY
Sponsors and Collaborators
Astellas Pharma Inc
Medivation, Inc.
Investigators
Study Director: Associate Medical Science Director Astellas Pharma Global Development
Principal Investigator: Principal Investigator Carolina Urologic Research Center
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01288911     History of Changes
Other Study ID Numbers: 9785-CL-0222, 2010-021868-15
Study First Received: February 1, 2011
Last Updated: August 7, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Belgium: Federal Agency for Medicinal Products and Health Products
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Romania: National Medicines Agency
Denmark: Danish Health and Medicines Authority

Keywords provided by Astellas Pharma Inc:
MDV3100
Prostate
Cancer
Metastatic
progressive
enzalutamide

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

ClinicalTrials.gov processed this record on September 22, 2014