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

This study is not yet open for participant recruitment.
Verified March 2011 by University Hospital Erlangen
Sponsor:
Information provided by:
University Hospital Erlangen
ClinicalTrials.gov Identifier:
NCT01409876
First received: August 3, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted

August 3, 2011
August 3, 2011
September 2011
September 2014   (final data collection date for primary outcome measure)
Evaluation of the feasibilty of histoscanning- based dose-painting image- guided interstitial brachytherapy [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
assessing tumor response and side effects [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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

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
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
Radiation: brachytherapy
interstitial image- guided PDR/HDR brachytherapy
Experimental: Brachytherapy
Intervention: Radiation: brachytherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
September 2016
September 2014   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact: Sebastian Lettmaier, MD 09131 85 44216 sebastianlettmaier@uk-erlangen.de
Germany
 
NCT01409876
HistoBrachy1
Not Provided
Sebastian Lettmaier, University Hospital Erlangen
University Hospital Erlangen
Not Provided
Not Provided
University Hospital Erlangen
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP