Spectro-IRM and Evaluation Response to Prostatic Radiotherapy
NCT ID: NCT01412853
Last Updated: 2017-06-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2008-02-29
2016-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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MR-spectroscopy
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
Interventions
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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 Criteria
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Inclusion Criteria
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
2. Bone metastases
3. Maximal baseline PSA ≥ 50 ng/ml
4. Prior radical prostatectomy
5. Contra-indications for MRI (Pace-maker, hip prothesis…)
18 Years
MALE
No
Sponsors
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Centre Georges Francois Leclerc
OTHER
Responsible Party
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Locations
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Centre Georges François Leclerc
Dijon, , France
Countries
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Other Identifiers
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0203-1crgi 07/005-046
Identifier Type: -
Identifier Source: org_study_id
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