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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
  Purpose

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

Condition Intervention Phase
Prostate Cancer
 Radiation: brachytherapy
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: HistoScanning- Based Dose-painting Image-guided Interstitial PDR-brachytherapy in Prostate Cancer - a Phase II Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital Erlangen:

Primary Outcome Measures:
  • Evaluation of the feasibilty of histoscanning- based dose-painting image- guided interstitial brachytherapy [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • assessing tumor response and side effects [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: September 2011
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brachytherapy Radiation: brachytherapy
interstitial image- guided PDR/HDR brachytherapy

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01409876

Contacts
Contact: Sebastian Lettmaier, MD 09131 85 44216 sebastianlettmaier@uk-erlangen.de

Locations
Germany
Department of Radiation Therapy University Hospital Not yet recruiting
Erlangen, Germany, 91054
Contact: Vratislav Strnad, MD, Prof     +49 9131 85 33419     vratislav.strnad@uk-erlangen.de    
Sponsors and Collaborators
University Hospital Erlangen
  More Information

No publications provided

Responsible Party: Sebastian Lettmaier, University Hospital Erlangen
ClinicalTrials.gov Identifier: NCT01409876     History of Changes
Other Study ID Numbers: HistoBrachy1
Study First Received: August 3, 2011
Last Updated: August 3, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Erlangen:
histoscanning
brachytherapy

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

ClinicalTrials.gov processed this record on May 16, 2013