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


N/A
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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


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…)

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

PSA value compare to Choline and Citrate levels as measured with MR-spectroscopic imaging as predictive factor of the response to treatment

Outcome Description:

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.

Outcome Time Frame:

up to 1 year

Safety Issue:

No

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

0203-1crgi 07/005-046

NCT ID:

NCT01412853

Start Date:

February 2008

Completion Date:

December 2013

Related Keywords:

  • Prostate Cancer
  • localized
  • Prostatic Neoplasms

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