HistScanning- Based PDR Brachytherapy in Prostate Cancer HistoScanning- Based Interstitial PDR Brachytherapy

Study Overview
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Brief Summary
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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 Evaluating tumor response using HistoScanning Evaluating locoregional recurrence rates by measuring PSA Analysis of the correlation between tumor response as determined by HistoScanning and PSA response Evaluating the safety dose-painting image- guided interstitial brachytherapy by recording serious adverse events

Detailed Description
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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

Official Title
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HistoScanning- Based Dose-painting Image-guided Interstitial PDR-brachytherapy in Prostate Cancer - a Phase II Trial

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: brachytherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brachytherapy<br> | Radiation: brachytherapy<br>* interstitial image- guided PDR/HDR brachytherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the feasibilty of histoscanning- based dose-painting image- guided interstitial brachytherapy |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessing tumor response and side effects |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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histoscanning, brachytherapy