Ion Prostate Irradiation
IPI
Hypofractionated Ion Irradiation (Carbon Ions Versus Protons) of the Prostate
1 other identifier
interventional
92
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2012
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 6, 2012
CompletedFirst Posted
Study publicly available on registry
July 16, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedMay 4, 2017
May 1, 2017
3.6 years
July 6, 2012
May 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
proctitis and cystitis
via incidence grade 3-4 toxicity (NCI-CTC-AE)
3 years
Secondary Outcomes (3)
PSA-PFS
3 years
OS
3 years
quality of life
3 years
Study Arms (2)
protons
EXPERIMENTALirradiation 20 x 3,3 GyE protons
carbon ions
EXPERIMENTALirradiation 20 x 3,3 GyE carbon ions
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Stadium IV (distant metastases) Lymphogenous Metastases hip replacement former irradiation of the pelvis pacemaker defibrillator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Heidelberg, Radiooncology, HIT
Heidelberg, 69120, Germany
Related 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.
PMID: 24641841BACKGROUNDHabl 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.
PMID: 27084659BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Klaus Herfarth, Prof. Dr.
University Hospital of Heidelberg
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. Herfarth
Study Record Dates
First Submitted
July 6, 2012
First Posted
July 16, 2012
Study Start
May 1, 2012
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
May 4, 2017
Record last verified: 2017-05