NCT01641185CompletedPhase 2
Hypofractionated Ion Irradiation (Carbon Ions Versus Protons) of the Prostate
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Heidelberg University
- Enrollment
- 92
- Locations
- 2
- Primary Endpoint
- proctitis and cystitis
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Exclusion Criteria
- •Stadium IV (distant metastases) Lymphogenous Metastases hip replacement former irradiation of the pelvis pacemaker defibrillator
Outcomes
Primary Outcomes
proctitis and cystitis
Time Frame: 3 years
via incidence grade 3-4 toxicity (NCI-CTC-AE)
Secondary Outcomes
- PSA-PFS(3 years)
- quality of life(3 years)
- OS(3 years)
Investigators
Klaus Herfarth, MD
Prof. Dr. Herfarth
Heidelberg University
Study Sites (2)
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