Spectro-IRM and Evaluation Response to Prostatic Radiotherapy (ERIS)
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.
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Evaluation of the Response to Irradiation With MR-Spectroscopy for Localised Prostate Cancer Patients (The ERIS Trial)|
- PSA value compare to Choline and Citrate levels as measured with MR-spectroscopic imaging as predictive factor of the response to treatment [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]Data will be collected at the end of the radiotherapy and every 3 months up to 1 year for each patient. Data analysis will be performed at the end of data completion in december 2011.
|Study Start Date:||February 2008|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
response to standard radiotherapy treatment will be estimated for each patient every 3 months up to one year from the end of the radiotherapy
Please refer to this study by its ClinicalTrials.gov identifier: NCT01412853
|Contact: Gilles Crehange, MD||3 80 73 75 18 ext +firstname.lastname@example.org|
|Contact: Jérémy Skrzypski, PHD||3 80 73 75 00 (3468) ext +email@example.com|
|Centre Georges François Leclerc||Recruiting|
|Dijon, France, 21000|
|Contact: Gilles Crehange, MD 3 80 73 75 18 ext +33 firstname.lastname@example.org|
|Contact: Jérémy Skrzypski, PHD 3 80 73 75 00 (3468) ext +33 email@example.com|
|Principal Investigator: Gilles Crehange, MD|