Hypofractionated Ion Irradiation (Carbon Ions Versus Protons) of the Prostate
Phase 2
40 Years
80 Years
40 Years
80 Years
Open (Enrolling)
Male
Exposure to Artificially Accelerated Beams of Ionized Particles Generated by Synchrotrons, Prostatic Neoplasms
Male
Exposure to Artificially Accelerated Beams of Ionized Particles Generated by Synchrotrons, Prostatic Neoplasms
Trial Information
Hypofractionated Ion Irradiation (Carbon Ions Versus Protons) of the Prostate
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
proctitis and cystitis
Outcome Description:
via incidence grade 3-4 toxicity (NCI-CTC-AE)
Outcome Time Frame:
3 years
Safety Issue:
No
Authority:
Germany: Ethics Commission
Study ID:
IPI
NCT ID:
NCT01641185
Start Date:
May 2012
Completion Date:
May 2015
Related Keywords:
- Exposure to Artificially Accelerated Beams of Ionized Particles Generated by Synchrotrons
- Prostatic Neoplasms
- prostate
- IPI
- hypofractionation
- carbon ions
- proton
- Neoplasms
- Prostatic Neoplasms
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