Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-31 @ 1:04 PM
Study NCT ID:
NCT01800058
Status:
COMPLETED
Last Update Posted:
2020-06-26
First Post:
2013-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Circulating Tumor Cells in High-Risk Prostate Cancer Treated With High-dose Radiotherapy and Hormone Therapy
Sponsor:
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Organization:
Study Overview
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.
Status:
COMPLETED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: