HistoScanning- Based Dose-painting Image-guided Interstitial PDR-brachytherapy in Prostate Cancer - a Phase II Trial
18 Years
N/A
Male
Prostate Cancer
Trial Information
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
Inclusion Criteria:
- Histologically proven prostate cancer
- All cT1-3 carcinomas independent of grading and PSA value
- Prostate volume< 70cc
- No distant metastases
- Karnofsky > 60
- Written informed consent from the patient regarding study participation
Exclusion criteria:
- All patients who do not meet the inclusion criteria
- T4 carcinomas
- Proven metastases N+ and/or M1
- Epidural or general anaesthesia not possible
- Pathological clotting parameters
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Evaluation of the feasibilty of histoscanning- based dose-painting image- guided interstitial brachytherapy
Outcome Time Frame:
5 years
Safety Issue:
Yes
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
HistoBrachy1
NCT ID:
NCT01409876
Start Date:
September 2011
Completion Date:
September 2016
Related Keywords:
- Prostate Cancer
- histoscanning
- brachytherapy
- Prostatic Neoplasms
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