Circulating Tumor Cells and Survival in Hormone Refractory Prostate Cancer (HRPC) Patients Receiving Chemotherapy

Immunicon276 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

276

Conditions

Hormone Refractory Prostate Cancer Prostate Cancer

Interventions

PhlebotomyPROCEDURE

Peripheral blood draws for evaluation of circulating tumor cells

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Overall Survival

Time frame: Up to 36 months from time of baseline draw

Secondary Outcomes

Progression Free Survival

Time frame: Up to 36 months after baseline draw