Ion Prostate Irradiation

Prostatic Neoplasms Clinical Trial

— IPI  

Official title:

Hypofractionated Ion Irradiation (Carbon Ions Versus Protons) of the Prostate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01641185
• Other study ID #: IPI
• Status: Completed
• Phase: Phase 2
• First received: July 6, 2012
• Last updated: May 1, 2017
• Start date: May 2012
• Est. completion date: December 2015

Study information

• Verified date: May 2017
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Procedure:
• radiation
radiation with protons or carbon ions

Locations

Country	Name	City	State
Germany	University of Heidelberg, Radiooncology, HIT	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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 Mar 19;14:202. doi: 10.1186/1471-2407-14-202. — View Citation

Habl G, Uhl M, Katayama S, Kessel KA, Hatiboglu G, Hadaschik B, Edler L, Tichy D, Ellerbrock M, Haberer T, Wolf MB, Schlemmer HP, Debus J, Herfarth K. Acute Toxicity and Quality of Life in Patients With Prostate Cancer Treated With Protons or Carbon Ions in a Prospective Randomized Phase II Study--The IPI Trial. Int J Radiat Oncol Biol Phys. 2016 May 1;95(1):435-43. doi: 10.1016/j.ijrobp.2016.02.025. Epub 2016 Feb 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proctitis and cystitis	via incidence grade 3-4 toxicity (NCI-CTC-AE)	3 years
Secondary	PSA-PFS	by measuring PSA values every 3 months	3 years
Secondary	OS		3 years
Secondary	quality of life	by questionnaire	3 years