Spectro-IRM and Evaluation Response to Prostatic Radiotherapy

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Other: MR-Spectroscopy

• Registration Number: NCT01412853
• Lead Sponsor: Centre Georges Francois Leclerc

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2011-08-08
• Study First Submitted QC: 2011-08-08
• Study First Posted: 2011-08-09
• Status Verified: 2016-06
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Last Update Submitted: 2017-06-20
• Last Update Posted: 2017-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 90

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...)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MR-spectroscopy	MR-Spectroscopy	-

Primary Outcome Measures

Name	Time	Method
PSA value compare to Choline and Citrate levels as measured with MR-spectroscopic imaging as predictive factor of the response to treatment	up to 1 year	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.

Trial Locations

Locations (1)

Centre Georges François Leclerc; 🇫🇷 Dijon, France