Circulating Tumor Cells and Survival in Hormone Refractory Prostate Cancer (HRPC) Patients Receiving Chemotherapy
Status unconfirmed
Conditions studied: Hormone Refractory Prostate Cancer, Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT00133900
- Run by
- Immunicon
- People needed
- 276
- Starts
- 2004-12-01
- Expected to finish
- 2009-02-01
- Last updated by the study team
- 2009-07-28
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Systemic radiation
- Prior history of other carcinoma within the last 5 years, except non-melanoma skin cancer
- Brain metastases
Where it is running
- Cleveland Clinic Taussig Cancer Center — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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