Patients Overexposed for a Prostate Adenocarcinoma

Completed

• Conditions: Prostate Adenocarcinoma
• Interventions: Other: Whole blood sample

• Registration Number: NCT00773656
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-15
• Study First Submitted QC: 2008-10-15
• Study First Posted: 2008-10-16
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-26
• Last Update Posted: 2014-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 249

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

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Exclusion Criteria

• No provision of informed consent
• Patient with disease worsening and in incapacity to move about to CHJM

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Whole blood sample	patients treated for a prostate adenocarcinoma

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Groupe Hospitalier Pitié-Salpêtrière; 🇫🇷 Paris, France