Patients With High-risk Prostate Cancer Clinical Trial
Official title:
Prognostic Value of the Levels of Circulating Tumor Cells (CTCs) in Peripheral Blood in Patients With Prostate Cancer at High Risk (Clinical Stages IIB-III) Treated Radically With Radiotherapy and Hormone Therapy.
The detection and quantification of Circulating tumor cells CTCs in peripheral blood of
patients with prostate adenocarcinoma may be useful at least for:
Getting a correct stratification of patients with high-risk prostate cancer (PCa).
Set the prognosis at baseline. Evaluate the response to different treatments (predictive
value and monitoring).
Establish individualized therapies.
Prospective analysis of biologic samples from peripheral blood of 65 patients with localized
high-risk PCa (NCCN 2011) treated with RTC-3D-IMRT combined with AD.
Following the sign of the informed consent of the patient, the blood samples will be analyzed
for CTCs using an immunomagnetic method based on the CellSearch system (Veridex), in 4
periods of time:
1. prior to any treatment;
2. following AD and prior to RT; and
3. following the end of RT (1-3 months afterwards).
4. six to twelve months following the end of RT in those patients with 0 CTCs in the first
determination and positive CTCs in the second or third determination
Comparison between the expression of CTCs in peripheral blood before and following AD and RT
will be performed. The quantification of the CTCs obtained in these phases of treatment will
be correlated with the treatment results in terms of biochemical failure according to Phoenix
definition, distant metastasis rate and overall survival to identify a significant prognostic
relationship and to determine the potential effect of the treatment in the number of CTCs Our
working group will include 65 patients because the amount is based on routine clinical
activity can be safely enrolled in the project development time by the participating centers.
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