Patients Overexposed for a Prostate Adenocarcinoma (EPOPA)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Prostate Adenocarcinoma

Treatments: Other: Whole blood sample

Study type: Observational

Funder types: Other

Identifiers

NCT00773656

AOM 08234

Details and patient eligibility

About

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).

Full 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.

Enrollment: 249 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

249 participants in 1 patient group

1

Description:

patients treated for a prostate adenocarcinoma

Treatment:

Other: Whole blood sample