Circulating Tumor Cells and Survival in Hormone Refractory Prostate Cancer (HRPC) Patients Receiving Chemotherapy
This trial is active, not recruiting.
|Conditions||hormone refractory prostate cancer, prostate cancer|
|Start date||December 2004|
|End date||February 2009|
|Trial size||276 participants|
|Trial identifier||NCT00133900, IMMC-38|
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.
Metastatic Hormone Refractory Prostate Cancer Patients
time frame: Up to 36 months from time of baseline draw
Progression Free Survival
time frame: Up to 36 months after baseline draw
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
|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|
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