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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

276 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-12-31

Study Completion Date

2009-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Hormone Refractory Prostate Cancer Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort

Metastatic Hormone Refractory Prostate Cancer Patients

Phlebotomy

Intervention Type PROCEDURE

Peripheral blood draws for evaluation of circulating tumor cells

Interventions

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Phlebotomy

Peripheral blood draws for evaluation of circulating tumor cells

Intervention Type PROCEDURE

Eligibility Criteria

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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