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A Randomized, Double-Blind, Phase II, Efficacy and Safety Study of MDV3100 Versus Bicalutamide in Castrate Men With Metastatic Prostate Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostatic Neoplasms

Thank you

Trial Information

A Randomized, Double-Blind, Phase II, Efficacy and Safety Study of MDV3100 Versus Bicalutamide in Castrate Men With Metastatic Prostate Cancer


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

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/kg, 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

Type of Study:

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

Outcome Measure:

Progression Free Survival

Outcome Time Frame:

24 months

Safety Issue:

No

Principal Investigator

Associate Medical Science Director

Investigator Role:

Study Director

Investigator Affiliation:

Astellas Pharma Global Development

Authority:

United States: Food and Drug Administration

Study ID:

9785-CL-0222

NCT ID:

NCT01288911

Start Date:

February 2011

Completion Date:

January 2014

Related Keywords:

  • Prostatic Neoplasms
  • MDV3100
  • Prostate
  • Cancer
  • Metastatic
  • progressive
  • Neoplasms
  • Prostatic Neoplasms

Name

Location

University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Medical College of Wisconsin Milwaukee, Wisconsin  53226
University of Kansas Medical Center Kansas City, Kansas  66160-7353
University of Rochester Medical Center Rochester, New York  14642
Wenatchee Valley Medical Center Wenatchee, Washington  98801-2028
University of Minnesota Minneapolis, Minnesota  55455
Billings Clinic Cancer Center Billings, Montana  59107-5100
Alaska Clinical Research Center, LLC Anchorage, Alaska  99508
Urological Associates Of Lancaster Lancaster, Pennsylvania  17604-3200
Northeast Indiana Research, LLC Fort Wayne, Indiana  46825-1675
Staten Island Urological Research, PC Staten Island, New York  10304
Carolina Urologic Research Center Myrtle Beach, South Carolina  29572
University of Maryland Greenebaum Cancer Center Baltimore, Maryland  21201
University of North Carolina - Chapel Hill Chapel Hill, North Carolina  27599
Columbus Urology Research, LLC Columbus, Ohio  43214
Urology San Antonio Research, PA San Antonio, Texas  78229
Urology Associates, PC Nashville, Tennessee  37209
Urology Enterprises Marietta, Georgia  30060
University Urology Associates New York, New York  10016
Rex Cancer Center Raleigh, North Carolina  27607
The Iowa Clinic Des Moines, Iowa  50309
Springfield Clinic Springfield, Illinois  62703
Seattle Urology Research Center Burien, Washington  
The Urology Center of Colorado Denver, Colorado  80211
Beaver Medical Group Highland, California  92346
Urology of Virginia, Sentara Medical Group Norfolk, Virginia  23503
Florida Urology Physicians Fort Myers, Florida  
Premier Medical Group of the Hudson Valley Poughkeepsie, New York  12601
Urology Centers of Alabama, PC Birmingham, Alabama  35209
Urology Associates of Southern Arizona Tucson, Arizona  85741
Tower Urology, Cedars-Sinai Office Towers Los Angeles, California  90048
Genesis Research San Diego, California  92123
Connecticut Clinical Research Center, LLC Middlebury, Connecticut  06762
Malcom Randal VAMC Gainesville, Florida  32608
UroPartners/RMD Clinical Research Melrose Park, Illinois  60160
Metropolitan Urology Clinical Research Jeffersonville, Indiana  47130
Myron I. Murdock MD, LLC Greenbelt, Maryland  20770
Spectrum Health Medical Group Grand Rapids, Michigan  69546
Premier Urology Associates, LLC / AdvanceMed Research Lawrenceville, New Jersey  08648
Alliance Urology Specialists, PA Greensboro, North Carolina  27403
Division of Urology Cincinnati, Ohio  45267
Urology Consultants of Southeastern Pennsylvania Bala Cynwyd, Pennsylvania  19444