Intensity-modulated Radiation Therapy From 70Gy to 80Gy in Localized Prostate Cancer

November 25, 2016 updated by: Institut de Cancérologie de Lorraine

The objective is to report outcomes,including grade ≥2 overall late rectal and urinary toxicity and biochemical control rates in patients treated with IMRT (70 gy, 74 Gy and 80 Gy)

Study Overview

Status

Completed

Conditions

Prostate Cancer

Intervention / Treatment

Radiation: Intensity-modulated radiation therapy

Study Type

Observational

Enrollment (Actual)

240

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Patients records would be extracted from the electronic health record system of Institut de Cancérologie de Lorraine

Description

Inclusion Criteria:

Consecutive patients from June 2000 to December 2010 with

untreated histologically confirmed adenocarcinoma of the prostate
stage T1c-T4 N0 M0 according to the 1992 American Joint Committee on Cancer staging system

Exclusion Criteria:

Patients with positive pelvic lymphadenectomy or radiological positives nodes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
grade≥ 2 overall late rectal 5 years after the end of radiotherapy Time Frame: 60 months	60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Cancérologie de Lorraine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

October 10, 2016

First Submitted That Met QC Criteria

November 25, 2016

First Posted (Estimate)

November 28, 2016

Study Record Updates

Last Update Posted (Estimate)