Spectro-IRM and Evaluation Response to Prostatic Radiotherapy

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Centre Georges François Leclerc

Dijon, 21000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

lymph-node metastases
Bone metastases
Maximal baseline PSA ≥ 50 ng/ml
Prior radical prostatectomy
Contra-indications for MRI (Pace-maker, hip prothesis…)

Treatment and study plan

MR-Spectroscopy

Other

response to standard radiotherapy treatment will be estimated for each patient every 3 months up to one year from the end of the radiotherapy

Primary outcomes

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

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.

Sponsors and collaborators

Lead sponsor

Centre Georges Francois Leclerc

Other

Registry information

Official study title

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

Acronym: ERIS

Important dates

Study start: 2008
Primary completion: 2016
Study completion: 2016
First posted: Aug 9, 2011
Registry last updated: Jun 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed