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.
18 Years
N/A
Male
Patients With High-risk Prostate Cancer
Trial Information
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.
Inclusion Criteria:
- Patients aged > 18 with capacity to give informed consent.
- Patients with histologically confirmed prostate cancer.
- Patients with a high risk factor: PSA> 20 ng / ml, Gleason 8-10 and / or stage T3a-b,
N0M0 (NCCN 2011, stage IIB-III AJCC classification 2010). Staging by:
Histology-Gleason score-, PSA, TR, ECO TR, CT, MRI.
- Patients who accept radical treatment with radiotherapy.
- Patients who give written informed consent to participate in the study
Exclusion Criteria:
- Any patient diagnosed with prostate cancer, which does not meet the prerequisites.
- Any patients with another malignancy diagnosed in the past 5 years (except basal cell
or squamous cell carcinoma of skin).
- Any patient who has prostate biopsy performed 7 days prior to study entry.
- Patients who have received prior treatment with hormonal therapy, chemotherapy or
radiotherapy.
- Patients with PSA> 100 ng / ml.
- Any situation or condition of the patient which in the opinion of the investigator,
advised against participation in the study.
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
expression of circulating tumor cells in the peripheral blood in the peripheral blood of patients with high-risk prostate cancer (NCCN 2011)
Outcome Description:
(Initially a cutoff point of > 3 or more circulating cells per 7.5 ml of blood will be taken as the reference baseline).
Outcome Time Frame:
Following the end of radiotherapy (1-3 months afterwards).
Safety Issue:
No
Principal Investigator
Almudena Zapatero, MD, PhD, PI
Investigator Role:
Principal Investigator
Investigator Affiliation:
Radiation Oncology Department_Hospital Universitario de La Princesa
Authority:
United States: Food and Drug Administration
Study ID:
CaPr-RTCTC-01/PI 197
NCT ID:
NCT01800058
Start Date:
March 2013
Completion Date:
April 2016
Related Keywords:
- Patients With High-risk Prostate Cancer
- Prostatic Neoplasms
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