Ignite Creation Date:
2024-05-05 @ 11:47 PM
Last Modification Date:
2024-10-26 @ 10:39 AM
Study NCT ID:
NCT01412853
Status:
COMPLETED
Last Update Posted:
2017-06-21
First Post:
2011-08-08
Brief Title:
Spectro-IRM and Evaluation Response to Prostatic Radiotherapy
Sponsor:
Centre Georges Francois Leclerc
Organization:
Centre Georges Francois Leclerc
Study Overview
Official Title:
Evaluation of the Response to Irradiation With MR-Spectroscopy for Localised Prostate Cancer Patients The ERIS Trial
Status:
COMPLETED
Status Verified Date:
2016-06
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:
ERIS
Brief Summary:
Context
Prostate cancer is the most common non-cutaneous cancer and the second most common cause of cancer-related deaths in European and North-American men
After external radiotherapy or brachytherapy the Prostate Specific Antigen PSA value is often fluctuating and PSA nadir may only be reached after 2 years or more and may remain detectable several years after the completion of radiation Moreover PSA bounces and blips render patients and physicians very anxious about any possibility of a relapse In this context biomarkers that could predict the response to radiation earlier than PSA for patients with prostate cancer appear long overdue
Magnetic Resonance Spectroscopy at 3 Tesla without endorectal coil is a non invasive procedure which allows quantification of metabolites such as Choline Creatine Polyamines and Citrate within the prostate gland
Objectives
The investigators are conducting a French prospective study on the Evaluation of the Response to Irradiation with MR Spectroscopy ERIS Their purpose is to monitor the early response of radiation with 3D MR Spectroscopy during the first year after completion of radiation and its impact on biochemical control Therefore the ERIS trial aims to investigate whether or not there could be a correlation between the time course of PSA and that of Choline and Citrate
Prostate cancer is the most common non-cutaneous cancer and the second most common cause of cancer-related deaths in European and North-American men
After external radiotherapy or brachytherapy the Prostate Specific Antigen PSA value is often fluctuating and PSA nadir may only be reached after 2 years or more and may remain detectable several years after the completion of radiation Moreover PSA bounces and blips render patients and physicians very anxious about any possibility of a relapse In this context biomarkers that could predict the response to radiation earlier than PSA for patients with prostate cancer appear long overdue
Magnetic Resonance Spectroscopy at 3 Tesla without endorectal coil is a non invasive procedure which allows quantification of metabolites such as Choline Creatine Polyamines and Citrate within the prostate gland
Objectives
The investigators are conducting a French prospective study on the Evaluation of the Response to Irradiation with MR Spectroscopy ERIS Their purpose is to monitor the early response of radiation with 3D MR Spectroscopy during the first year after completion of radiation and its impact on biochemical control Therefore the ERIS trial aims to investigate whether or not there could be a correlation between the time course of PSA and that of Choline and Citrate
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None