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.
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 3 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). 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.
Observational Model: Case-Only, Time Perspective: Prospective
expression of circulating tumor cells in the peripheral blood in the peripheral blood of patients with high-risk prostate cancer (NCCN 2011)
(Initially a cutoff point of > 3 or more circulating cells per 7.5 ml of blood will be taken as the reference baseline).
Following the end of radiotherapy (1-3 months afterwards).
Almudena Zapatero, MD, PhD, PI
Radiation Oncology Department_Hospital Universitario de La Princesa
United States: Food and Drug Administration