Circulating Tumor Cells and the Prediction of Overall Survival in Patients With Androgen Independent Prostate Cancer Entering Onto Chemotherapy
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Hormone Refractory Prostate Cancer
- Sponsor
- Immunicon
- Enrollment
- 276
- Locations
- 1
- Primary Endpoint
- Overall Survival
- Last Updated
- 16 years ago
Overview
Brief 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.
Investigators
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
- •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
Outcomes
Primary Outcomes
Overall Survival
Time Frame: Up to 36 months from time of baseline draw
Secondary Outcomes
- Progression Free Survival(Up to 36 months after baseline draw)