Ion Prostate Irradiation

Heidelberg University92 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostatic Neoplasms

Interventions

radiationPROCEDURE

radiation with protons or carbon ions

Eligibility

Sex: MALEMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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 Exclusion Criteria: Stadium IV (distant metastases) Lymphogenous Metastases hip replacement former irradiation of the pelvis pacemaker defibrillator

Locations (1)

University of Heidelberg, Radiooncology, HIT

Heidelberg, Germany

Outcomes

Primary Outcomes

proctitis and cystitis

via incidence grade 3-4 toxicity (NCI-CTC-AE)

Time frame: 3 years

Secondary Outcomes

PSA-PFS

by measuring PSA values every 3 months

Time frame: 3 years

quality of life

by questionnaire

Time frame: 3 years

Data from ClinicalTrials.gov

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