Patients Overexposed for a Prostate Adenocarcinoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Prostate Adenocarcinoma

Intervention / Treatment
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* Other: Whole blood sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: provision of informed consent patient treated for prostate adenocarcinoma and overexposed during radiotherapy in a prostate adenocarcinoma in the radiation department of the a prostate adenocarcinoma in the radiation department of the Jean MONNET hospital/ service de radiotherapies between 2000 and 2006 Exclusion Criteria: No provision of informed consent Patient with disease worsening and in incapacity to move about to CHJM

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>patients treated for a prostate adenocarcinoma | Other: Whole blood sample<br>* 70 ml per patient for collection of biological sample<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To correlate the received doses, the volume of irradiated normal tissues, the events, with biologic, phenotypic and genetic data. |  | At the inclusion visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between adverse events and radiation doses with biologic, phenotypic and genetic data. |  | At the inclusion visit | 
| Evaluation of T-lymphocyte apoptosis to predict radiation-induced late toxicity |  | At the inclusion visit | 
| Gene associations with risks for adverse events related to radiotherapy |  | At the inclusion visit | 
| Levels of circulating microparticles and bystander effect after irradiation |  | At the inclusion visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiotherapy, Biologically effective dose, Radiation injury