Prostate Cancer Clinical Trial
Circulating Tumor Cells and Survival in Hormone Refractory Prostate Cancer (HRPC) Patients Receiving Chemotherapy
Summary
This study enrolled men with prostate cancer who had failed hormone therapy (as shown by rising prostate-specific antigen [PSA] levels) and who were about to start a new line of chemotherapy. Blood was drawn prior to the patient receiving chemotherapy and then monthly thereafter for up to 18 months or until disease progression, whichever occurred first. The blood was tested to find circulating tumor cells (CTC) and to count them. The circulating tumor cell levels were studied in relation to the patient's overall survival. Serum was also collected for PSA testing, and additional blood samples were drawn to test for circulating endothelial cells and RNA was isolated for future gene expression testing.
Eligibility Criteria
Inclusion Criteria:
Age > or = 18 years
Pathological diagnosis of adenocarcinoma of the prostate
First or later line of chemotherapy
Serum testosterone < 50ng/mL
ECOG 0-2
Serum PSA > or = 5ng/mL
PSA progression (2 rises above a reference value)
Bone scan within 60 days of enrollment
Computed tomography (CT) scan
If measurable disease, bone scans every 6-8 months
Exclusion Criteria:
Systemic radiation
Prior history of other carcinoma within the last 5 years, except non-melanoma skin cancer
Brain metastases
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There is 1 Location for this study
Cleveland Ohio, 44195, United States
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