Prostate Adenocarcinoma
Conditions
Keywords
Radiotherapy, Biologically effective dose, Radiation injury
Brief 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.
Interventions
70 ml per patient for collection of biological sample
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
France