Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00004126

Trial Description

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Title

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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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

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Brief Summary in Scientific Language

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

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00004126
  •   2012/10/12
  •   2011/08/03
  •   yes
  •   [---]*
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Secondary IDs

  •   NCT01409876  (ClinicalTrials.gov)
  •   HistoBrachy1  (University Hospital Erlangen)
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Health Condition or Problem studied

  •   Prostate Cancer
  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   Radiation: brachytherapy
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   II
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Primary Outcome

- Evaluation of the feasibilty of histoscanning- based dose-painting image- guided interstitial brachytherapy; time frame: 5 years

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Secondary Outcome

- assessing tumor response and side effects; time frame: 5 years

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2011/09/30
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional Inclusion 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

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Exclusion Criteria

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

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Addresses

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    • University Hospital Erlangen
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    • Sebastian Lettmaier, MD 
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    end of 1:1-Block address contact scientific-contact
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    • Sebastian Lettmaier, MD 
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   7
  •   2018/06/21


* This entry means the parameter is not applicable or has not been set.