Overview

This trial is active, not recruiting.

Conditions hormone refractory prostate cancer, prostate cancer
Treatment phlebotomy
Sponsor Immunicon
Start date December 2004
End date February 2009
Trial size 276 participants
Trial identifier NCT00133900, IMMC-38

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Metastatic Hormone Refractory Prostate Cancer Patients
phlebotomy
Peripheral blood draws for evaluation of circulating tumor cells

Primary Outcomes

Measure
Overall Survival
time frame: Up to 36 months from time of baseline draw

Secondary Outcomes

Measure
Progression Free Survival
time frame: Up to 36 months after baseline draw

Eligibility Criteria

Male participants at least 18 years old.

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

Additional Information

Official title Circulating Tumor Cells and the Prediction of Overall Survival in Patients With Androgen Independent Prostate Cancer Entering Onto Chemotherapy
Principal investigator Ken Pienta, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2009.
Information provided to ClinicalTrials.gov by Immunicon.