Baltimore, Maryland 21287

  • Prostate Cancer


The purpose of this study is to determine the proportion of patients with a serological prostate specific antigen (PSA) by day 85.

Study summary:

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.


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CT scans - has increasing serum PSA concentrations - life expectancy of at least 3 months - ECOG of 0 or 1 - has been withdrawn from antiandrogen therapy for at least 6 weeks prior to entering screening period Exclusion Criteria: - has asymptomatic disease - has active GI ulceration or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



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Location Contact:

Baltimore, Maryland 21287
United States

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Site Status: N/A

Data Source:

Date Processed: March 30, 2020

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