Prostate Cancer
Conditions
Keywords
prostate cancer, prostate specific antigen, PSA
Brief summary
The purpose of this study is to determine the proportion of patients with a serological prostate specific antigen (PSA) by day 85.
Detailed description
A serological PSA response is defined as a reduction from baseline PSA serum concentration of at least 50%, which is confirmed by a second PSA value 28 or more days later.
Interventions
DRUGCEP-701
Sponsors
Cephalon
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* at least 18 yrs of age * diagnosis of adenocarcinoma of the prostate * no detectable metastatic disease as assessed by bone and CT scans * has increasing serum PSA concentrations * life expectancy of at least 3 months * ECOG of 0 or 1 * has been withdrawn from antiandrogen therapy for at least 6 weeks prior to entering screening period
Exclusion criteria
* has asymptomatic disease * has active GI ulceration or bleeding * has been treated with non-hormonal systemic anticancer therapy or has received radiation within 4 weeks of baseline visit * bilirubin \>2x ULN or ALT or AST \>2xULN or serum creatinine \>1.5mg/dL * hemoglobin \<9g/dL or platelets below 100,000/uL or ANC below 1500/uL * receiving treatment for HIV with protease inhibitors * has had prior malignancy within past 5 yrs with exception of resected basal or squamous cell carcinomas of the skin * has used investigational drug with previous one month
Countries
United States
Outcome results
None listed