Clinical Trials Directory

Trials / Completed

CompletedNCT01412853

Spectro-IRM and Evaluation Response to Prostatic Radiotherapy

Evaluation of the Response to Irradiation With MR-Spectroscopy for Localised Prostate Cancer Patients (The ERIS Trial)

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
90 (actual)
Sponsor
Centre Georges Francois Leclerc · Academic / Other
Sex
Male
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERMR-Spectroscopyresponse to standard radiotherapy treatment will be estimated for each patient every 3 months up to one year from the end of the radiotherapy

Timeline

Start date
2008-02-01
Primary completion
2016-12-01
Completion
2016-12-01
First posted
2011-08-09
Last updated
2017-06-21

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT01412853. Inclusion in this directory is not an endorsement.