Spectro-IRM and Evaluation Response to Prostatic Radiotherapy

Prostate Cancer Clinical Trial

— ERIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01412853
• Other study ID #: 0203-1crgi 07/005-046
• Status: Completed
• Phase: N/A
• First received: August 8, 2011
• Last updated: June 20, 2017
• Start date: February 2008
• Est. completion date: December 2016

Study information

• Verified date: June 2016
• Source: Centre Georges Francois Leclerc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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…)

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	Centre Georges François Leclerc	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Georges Francois Leclerc

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PSA value compare to Choline and Citrate levels as measured with MR-spectroscopic imaging as predictive factor of the response to treatment	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.	up to 1 year