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Spectro-IRM and Evaluation Response to Prostatic Radiotherapy (ERIS)

This study is currently recruiting participants.
Verified September 2012 by Centre Georges Francois Leclerc
Sponsor:
Information provided by (Responsible Party):
Centre Georges Francois Leclerc
ClinicalTrials.gov Identifier:
NCT01412853
First received: August 8, 2011
Last updated: September 24, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention
Prostate Cancer
 Other: MR-Spectroscopy

Study Type: Interventional
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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre Georges Francois Leclerc:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 100
Study Start Date: February 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MR-spectroscopy Other: MR-Spectroscopy
response to standard radiotherapy treatment will be estimated for each patient every 3 months up to one year from the end of the radiotherapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with a biopsy-proven prostatic adenocarcinoma
  2. Gleason score between 4 and 10
  3. Maximal baseline PSA < 50 ng/ml
  4. Age over or = to 18 yr
  5. Exclusive radiotherapy and/or brachytherapy with or without androgen deprivation therapy
  6. Written informed consent from the patient

Exclusion Criteria:

  1. lymph-node metastases
  2. Bone metastases
  3. Maximal baseline PSA ≥ 50 ng/ml
  4. Prior radical prostatectomy
  5. Contra-indications for MRI (Pace-maker, hip prothesis…)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01412853

Contacts
Contact: Gilles Crehange, MD 3 80 73 75 18 ext +33 gcrehange@cgfl.fr
Contact: Jérémy Skrzypski, PHD 3 80 73 75 00 (3468) ext +33 jskrzypski@cgfl.fr

Locations
France
Centre Georges François Leclerc Recruiting
Dijon, France, 21000
Contact: Gilles Crehange, MD     3 80 73 75 18 ext +33     gcrehange@cgfl.fr    
Contact: Jérémy Skrzypski, PHD     3 80 73 75 00 (3468) ext +33     jskrzypski@cgfl.fr    
Principal Investigator: Gilles Crehange, MD            
Sponsors and Collaborators
Centre Georges Francois Leclerc
  More Information

No publications provided

Responsible Party: Centre Georges Francois Leclerc
ClinicalTrials.gov Identifier: NCT01412853     History of Changes
Other Study ID Numbers: 0203-1crgi 07/005-046
Study First Received: August 8, 2011
Last Updated: September 24, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Georges Francois Leclerc:
localized

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on June 18, 2013