A Phase 2, Randomized, Two Part Trial of Galeterone in the Treatment of Castration Resistant Prostate Cancer
This trial will be split into two parts. The purpose of Part 1 will be to confirm dose and
target patient population and Part 2 will be expansion of the dose and patient population
selected in Part 1. For eligible patients, there will be an optional extension dosing
following the completion of Part 1 or Part 2 of the trial.
Obtaining of informed consent and screening may be performed up to 28 days prior to
enrollment. Each patient will be able to receive his specified regimen for 3 consecutive
cycles. Each cycle consists of 28 days (approximately 1 mo.). End of Cycle 3 visit
assessments will be used to determine outcome and dosing may continue up to an additional 2
weeks until the results of all assessments are obtained. Eligible patients may continue
treatment in an optional extension period following the completion of the primary parts of
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Part 1 will confirm dose to be used in Part B of the study by assessing safety and efficacy by means PSA response.
This study will monitor frequency and severity of adverse events and changes in laboratory values. This study will also assess changes in levels of prostate specific antigen as a measure of treatment response
Bruce Montgomery, M.D.
University of Washington/Seattle Cancer Care Alliance
United States: Food and Drug Administration
|Dana Farber Cancer Institute||Boston, Massachusetts 02115|
|San Bernardino Urological Associates||San Bernardino, California|
|University of Washington/Seattle Cancer Care Alliance||Seattle, Washington 98109|
|Greenville Hospital System University Medical Center||Greenville, South Carolina 29605|
|Urology Cancer Center and GU Research Network||Omaha, Nebraska|
|Texas Urology||Carollton, Texas 75010|