Prostate Cancer Clinical Trial
Official title:
HistoScanning- Based Dose-painting Image-guided Interstitial PDR-brachytherapy in Prostate Cancer - a Phase II Trial
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
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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