Ion Prostate Irradiation (IPI)

Heidelberg University

Status and phase: Completed; Phase 2

Conditions: Prostatic Neoplasms

Treatments: Procedure: radiation

Study type: Interventional

Funder types: Other

Identifiers

NCT01641185

IPI

Details and patient eligibility

About

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.

Full 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

Enrollment: 92 patients

Sex: Male

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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92 participants in 2 patient groups

protons

Experimental group

Description:

irradiation 20 x 3,3 GyE protons

Treatment:

Procedure: radiation

carbon ions

Experimental group

Description:

irradiation 20 x 3,3 GyE carbon ions

Treatment:

Procedure: radiation