Ion Prostate Irradiation

Phase 2

Completed

• Conditions: Prostatic Neoplasms
• Interventions: Procedure: radiation

• Registration Number: NCT01641185
• Lead Sponsor: Heidelberg University

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-07-06
• Study First Submitted QC: 2012-07-13
• Study First Posted: 2012-07-16
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-01
• Last Update Posted: 2017-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
carbon ions	radiation	irradiation 20 x 3,3 GyE carbon ions
protons	radiation	irradiation 20 x 3,3 GyE protons

Primary Outcome Measures

Name	Time	Method
proctitis and cystitis	3 years	via incidence grade 3-4 toxicity (NCI-CTC-AE)

Secondary Outcome Measures

Name	Time	Method
PSA-PFS	3 years	by measuring PSA values every 3 months
quality of life	3 years	by questionnaire
OS	3 years

Trial Locations

Locations (1)

University of Heidelberg, Radiooncology, HIT; 🇩🇪 Heidelberg, Germany