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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01409876
Recruitment Status : Unknown
Verified March 2011 by University Hospital Erlangen.
Recruitment status was:  Not yet recruiting
First Posted : August 4, 2011
Last Update Posted : August 4, 2011
Information provided by:
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


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

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: brachytherapy Phase 2

Detailed Description:


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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: HistoScanning- Based Dose-painting Image-guided Interstitial PDR-brachytherapy in Prostate Cancer - a Phase II Trial
Study Start Date : September 2011
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Brachytherapy Radiation: brachytherapy
interstitial image- guided PDR/HDR brachytherapy

Primary Outcome Measures :
  1. Evaluation of the feasibilty of histoscanning- based dose-painting image- guided interstitial brachytherapy [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. assessing tumor response and side effects [ Time Frame: 5 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01409876

Contact: Sebastian Lettmaier, MD 09131 85 44216

Department of Radiation Therapy University Hospital Not yet recruiting
Erlangen, Germany, 91054
Contact: Vratislav Strnad, MD, Prof    +49 9131 85 33419   
Sponsors and Collaborators
University Hospital Erlangen

Responsible Party: Sebastian Lettmaier, University Hospital Erlangen Identifier: NCT01409876     History of Changes
Other Study ID Numbers: HistoBrachy1
First Posted: August 4, 2011    Key Record Dates
Last Update Posted: August 4, 2011
Last Verified: March 2011

Keywords provided by University Hospital Erlangen:

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases