Clinical trial NCT00773656: Patients Overexposed for a Prostate Adenocarcinoma
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Adenocarcinoma
Keywords: Radiotherapy
Biologically effective dose
Radiation injury
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2008-10-16
Enrollment: 249
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients treated for a prostate adenocarcinoma in the radiation department of the Jean MONNET Hospital between 2000 and 2006.

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.

Eligibility criteria: 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

Primary outcomes:
measure: To correlate the received doses, the volume of irradiated normal tissues, the events, with biologic, phenotypic and genetic data.
timeFrame: At the inclusion visit
Secondary outcomes:
measure: Correlation between adverse events and radiation doses with biologic, phenotypic and genetic data.
timeFrame: At the inclusion visit
measure: Evaluation of T-lymphocyte apoptosis to predict radiation-induced late toxicity
timeFrame: At the inclusion visit
measure: Gene associations with risks for adverse events related to radiotherapy
timeFrame: At the inclusion visit
measure: Levels of circulating microparticles and bystander effect after irradiation
timeFrame: At the inclusion visit
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Pitié-Salpêtrière
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jean Marc SIMON, PH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alsbeih G, El-Sebaie M, Al-Harbi N, Al-Buhairi M, Al-Hadyan K, Al-Rajhi N. Radiosensitivity of human fibroblasts is associated with amino acid substitution variants in susceptible genes and correlates with the number of risk alleles. Int J Radiat Oncol Biol Phys. 2007 May 1;68(1):229-35. doi: 10.1016/j.ijrobp.2006.12.050. Epub 2007 Feb 27.