HistScanning- Based PDR Brachytherapy in Prostate Cancer HistoScanning- Based Interstitial PDR Brachytherapy
- Conditions
- Prostate Cancer
- Interventions
- Radiation: brachytherapy
- Registration Number
- NCT01409876
- Lead Sponsor
- University Hospital Erlangen
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 100
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Brachytherapy brachytherapy -
- Primary Outcome Measures
Name Time Method Evaluation of the feasibilty of histoscanning- based dose-painting image- guided interstitial brachytherapy 5 years
- Secondary Outcome Measures
Name Time Method assessing tumor response and side effects 5 years
Trial Locations
- Locations (1)
Department of Radiation Therapy University Hospital
🇩🇪Erlangen, Germany