Prostatic Neoplasms
Conditions
Keywords
prostate, IPI, hypofractionation, carbon ions, proton
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. http://www.ncbi.nlm.nih.gov/pubmed/24641841
Interventions
PROCEDUREradiation
radiation with protons or carbon ions
Sponsors
Heidelberg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to 80 Years
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 * PSA
Exclusion criteria
Stadium IV (distant metastases) Lymphogenous Metastases hip replacement former irradiation of the pelvis pacemaker defibrillator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| proctitis and cystitis | 3 years | via incidence grade 3-4 toxicity (NCI-CTC-AE) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PSA-PFS | 3 years | by measuring PSA values every 3 months |
| OS | 3 years | — |
| quality of life | 3 years | by questionnaire |
Countries
Germany
Outcome results
None listed