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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01409876
• Other study ID #: HistoBrachy1
• Status: Not yet recruiting
• Phase: Phase 2
• First received: August 3, 2011
• Last updated: August 3, 2011
• Start date: September 2011
• Est. completion date: September 2016

Study information

• Verified date: March 2011
• Source: University Hospital Erlangen
• Contact: Sebastian Lettmaier, MD
• Phone: 09131 85 44216
• Email: sebastianlettmaier[@]uk-erlangen.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 2016
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• brachytherapy
interstitial image- guided PDR/HDR brachytherapy

Locations

Country	Name	City	State
Germany	Department of Radiation Therapy University Hospital	Erlangen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Erlangen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the feasibilty of histoscanning- based dose-painting image- guided interstitial brachytherapy		5 years	Yes
Secondary	assessing tumor response and side effects		5 years	Yes