NCT00773656

Patients Overexposed for a Prostate Adenocarcinoma

Surveillance of the Cohort of Patients Overexposed in a Course of Conformational Radiotherapy for a Prostate Adenocarcinoma in Jean MONNET Hospital, Epinal, France. Epinal: Patients Overexposed for a Prostate Adenocarcinoma

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 249 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Background: Between 2000 and 2006, 433 patients were overexposed (8% to 10%) during a course of conformal radiotherapy for a prostate adenocarcinoma in Jean MONNET hospital, Epinal, France. Among them, twenty four patients received an additional mean dose about 20%, due to an inappropriate use of the treatment planning system. Severe adverse events (proctitis, cystitis, and tissue necrosis) have occurred among most of these overexposed patients. We propose to develop several research programs in order to increase the scientific knowledge on iatrogenic effects related to overexposure of ionizing radiation, by studying their relationship with dosimetric, clinical, biologic and genetic characteristics. Aim of the study: To correlate the received doses, the volume of irradiated normal tissues, the events, with biologic, phenotypic and genetic data. Primary study endpoint: Incidence and severity of adverse events related to radiotherapy (according to SOMA - LENT and CTCAE scales).

Detailed description

Secondary study endpoint: * Correlation between adverse events and radiation doses with biologic, phenotypic and genetic data. * Evaluation of T-lymphocyte apoptosis to predict radiation-induced late toxicity * Gene associations with risks for adverse events related to radiotherapy * Levels of circulating microparticles and bystander effect after irradiation Inclusion criteria: Consecutive patients treated for a prostate adenocarcinoma in the radiation department of the Jean MONNET Hospital between 2000 and 2006. Potential. Better identification of patients at high risk of adverse events related to radiotherapy.

Conditions

• Prostate Adenocarcinoma

Interventions

Type	Name	Description
OTHER	Whole blood sample	70 ml per patient for collection of biological sample

Timeline

• Start date: 2008-10-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2008-10-16
• Last updated: 2014-02-27

Locations

1 site across 1 country: France