NCT01409876

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University Hospital Erlangen · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
RADIATION	brachytherapy	interstitial image- guided PDR/HDR brachytherapy

Timeline

• Start date: 2011-09-01
• Primary completion: 2014-09-01
• Completion: 2016-09-01
• First posted: 2011-08-04
• Last updated: 2011-08-04

Locations

1 site across 1 country: Germany