Ion Prostate Irradiation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2015-12-31

Brief Summary

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The purpose of this study is to evaluate the safety and feasibility of primary hypofractionated irradiation of the prostate with carbon ions or protons using the raster scan technique.

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Detailed Description

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as published: Habl G, Hatiboglu G, Edler L, Uhl M, Krause S, Roethke M, Schlemmer HP, Hadaschik B, Debus J, Herfarth K: Ion Prostate Irradiation (IPI) - a pilot study to establish the safety and feasibility of primary hypofractionated irradiation of the prostate with protons and carbon ions in a raster scan technique. BMC cancer 2014, 14(1):202.

http://www.ncbi.nlm.nih.gov/pubmed/24641841

Conditions

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Prostatic Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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protons

irradiation 20 x 3,3 GyE protons

Group Type EXPERIMENTAL

radiation

Intervention Type PROCEDURE

radiation with protons or carbon ions

carbon ions

irradiation 20 x 3,3 GyE carbon ions

Group Type EXPERIMENTAL

radiation

Intervention Type PROCEDURE

radiation with protons or carbon ions

Interventions

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radiation

radiation with protons or carbon ions

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

histological proven carcinoma of the prostate with Gleason score risk of lymphe node involvement of \<15% calculated by the Yale-formula; Risk \[%\] = \[GS -5\] x \[PSA/3 + 1.5 x T\], mit T = 0, 1, and 2 for cT1c, cT2a, und cT2b/cT2c

* Karnofsky-Index ≥ 70%
* age between 40 and 80 years
* PSA