HistoScanning- Based Dose-painting Image-guided Interstitial PDR-brachytherapy in Prostate Cancer - a Phase II Trial
Rationale:
The study is designed as a prospective monocentric phase II trial. The choice of the
therapeutic concept is governed by the risk group that the patient falls into. Risk groups
are defined according to the classification by D' Amico.
The following concepts will be used:
HDR brachytherapy: 19,0- 38 Gy / 2-4 fractions (2-4 x 9,5 Gy)
PDR brachytherapy: 35-70 Gy / 50 --100 pulses(1 puls/h, 24 h/d)
Dose painting the timorous areas as seen in HistoScanning as covered with a dose
Dref2>130-150%
External beam radiotherapy will be used in addition to brachytherapy for intermediate and
high risk patients. The following concepts will be used 50,40 Gy / 28 fractions at 1.8 Gy
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluation of the feasibilty of histoscanning- based dose-painting image- guided interstitial brachytherapy
5 years
Yes
Germany: Federal Institute for Drugs and Medical Devices
HistoBrachy1
NCT01409876
September 2011
September 2016
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