Hormone Refractory Prostate Cancer, Prostate Cancer
Conditions
Keywords
hormone refractory prostate cancer
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.
Interventions
PROCEDUREPhlebotomy
Peripheral blood draws for evaluation of circulating tumor cells
Sponsors
Immunicon
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival | Up to 36 months from time of baseline draw |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival | Up to 36 months after baseline draw |
Countries
United States
Outcome results
None listed