Spectro-IRM and Evaluation Response to Prostatic Radiotherapy

NCT01412853 | Completed

• 1 other identifier: 0203-1crgi 07/005-046
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

localized

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

MR-spectroscopy

EXPERIMENTAL

Other: MR-Spectroscopy

Interventions

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

MR-spectroscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Georges Francois Leclerc: lead

Study Sites (1)

Centre Georges François Leclerc

Dijon, 21000, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2011
• First Posted: August 9, 2011
• Study Start: February 1, 2008
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: June 21, 2017

Record last verified: 2016-06

Locations

FR (1)