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Brief Title: HistScanning- Based PDR Brachytherapy in Prostate Cancer HistoScanning- Based Interstitial PDR Brachytherapy
Official Title: HistoScanning- Based Dose-painting Image-guided Interstitial PDR-brachytherapy in Prostate Cancer - a Phase II Trial
Study ID: NCT01409876
Brief Summary: 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
Detailed Description: 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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Department of Radiation Therapy University Hospital, Erlangen, , Germany