Circulating Tumor Cells and Survival in Hormone Refractory Prostate Cancer (HRPC) Patients Receiving Chemotherapy (IMMC-38)

Immunicon

Status: Unknown

Conditions: Hormone Refractory Prostate Cancer; Prostate Cancer

Treatments: Procedure: Phlebotomy

Study type: Observational

Funder types: Industry

Identifiers

NCT00133900

IMMC-38

Details and patient eligibility

About

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.

Enrollment: 276 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

276 participants in 1 patient group

Cohort

Description:

Metastatic Hormone Refractory Prostate Cancer Patients

Treatment:

Procedure: Phlebotomy