This is a phase II trial looking at the feasibility of HistoScanning- based dose-painting image- guided interstitial brachytherapy in non- metastatic prostate cancer Endpoints: Primary endpoint Evaluation of the feasibility of HistoScanning- based dose-painting image- guided interstitial brachytherapy Secondary endpoints 1. Evaluating tumor response using HistoScanning 2. Evaluating locoregional recurrence rates by measuring PSA 3. Analysis of the correlation between tumor response as determined by HistoScanning and PSA response 4. Evaluating the safety dose-painting image- guided interstitial brachytherapy by recording serious adverse events
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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
interstitial image- guided PDR/HDR brachytherapy
Department of Radiation Therapy University Hospital
Erlangen, Germany
Evaluation of the feasibilty of histoscanning- based dose-painting image- guided interstitial brachytherapy
Time frame: 5 years
assessing tumor response and side effects
Time frame: 5 years
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