- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01641185
Ion Prostate Irradiation (IPI)
Hypofractionated Ion Irradiation (Carbon Ions Versus Protons) of the Prostate
Study Overview
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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Heidelberg, Germany, 69120
- University of Heidelberg, Radiooncology, HIT
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: protons
irradiation 20 x 3,3 GyE protons
|
radiation with protons or carbon ions
|
Experimental: carbon ions
irradiation 20 x 3,3 GyE carbon ions
|
radiation with protons or carbon ions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
proctitis and cystitis
Time Frame: 3 years
|
via incidence grade 3-4 toxicity (NCI-CTC-AE)
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
OS
Time Frame: 3 years
|
3 years
|
|
PSA-PFS
Time Frame: 3 years
|
by measuring PSA values every 3 months
|
3 years
|
quality of life
Time Frame: 3 years
|
by questionnaire
|
3 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Klaus Herfarth, Prof. Dr., University Hospital of Heidelberg
Publications and helpful links
General Publications
- 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.
- 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):435-443. doi: 10.1016/j.ijrobp.2016.02.025. Epub 2016 Feb 12.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IPI
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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