Trial document





This trial has been registered retrospectively.
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  DRKS00002954

Trial Description

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Title

The effect of radiation therapy of the prostate on parameters, which can be acquired by magnetic resonance tomography: relaxation times, apparent diffusion coefficient and perfusion.

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Trial Acronym

N/A

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The focus is on the clinical monitoring of prostate cancer undergoing radiotherapy treatment. It is based on imaging with magnetic resonance imaging (MRI) and quantitative determination of parameters to be checked whether these parameters are used as an indicator for the early response and therapeutic follow-up. Established MRI sequences are used. Currently observation of prostate specific antigen (PSA) is used to monitor response after radiotherapy. The PSA is a global parameter for the entire prostate gland and is recovering from radiation therapy after 1.5 years at a normal level. Since MRI is an imaging procedure response parameters are determined locally. The changes in the specific MRI parameters, in addition to those of the PSA are compared.

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Brief Summary in Scientific Language

The focus is on the clinical monitoring of prostate cancer undergoing radiotherapy treatment. It is based on imaging with magnetic resonance imaging (MRI) and quantitative determination of parameters to be checked whether these parameters are used as an indicator for the early response and therapeutic follow-up. In this first phase of the project, relaxation times, the "Apparent" diffusion coefficient (ADC) and perfusion in a patient prior to study, to be determined later during and immediately after radiotherapy and 6 months. Established MRI sequences are used. Currently observation of prostate specific antigen (PSA) is used to monitor response after radiotherapy. The PSA is a global parameter for the entire prostate gland and is recovering from radiation therapy after 1.5 years at a normal level. Since MRI is an imaging procedure response parameters are determined locally. The changes in the specific MRI parameters, in addition to those of the PSA are compared. The determination of PSA is a blood sample using a standard procedure.

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Organizational Data

  •   DRKS00002954
  •   2012/05/09
  •   [---]*
  •   yes
  •   Approved
  •   280/10, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   Study protocol MRI (3.0 Tesla):
    1. Localizer sequence to plan scan orientations
    2. high-resolution T2-weighted images in sagittal, coronal and axial orientation
    3. diffusion-weighted (DWI) images with different diffusion weighting, to determine apparent diffusion coefficient (ADC)
    4. T2-weighted images with different echo times in the axial orientation in order to determine the relaxation time T2.
    5. T2 *-weighted images with different echo times in the axial orientation in order to determine the relaxation time T2 *.
    6. T1-weighted MR images with different T1-weighted image in order to determine the relaxation time T1
    7. Time series (dynamic) T1-weighted MR images before, during and after contrast agent administration in order to evaluate the tissue-perfusion (dynamic contrast-enhancement, DCE)
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Based on MRI to quantitative parameters (relaxation times, "Apparent" diffusion coefficient and perfusion) are determined before and after radiotherapy of prostate cancer.

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Secondary Outcome

A correlation between changes in MRI parameters and the PSA level can be checked further.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2011/03/23
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Male patients older than 18 years, with histologically confirmed prostate cancer.
- Where the biopsy at the time of the first MR examination at least 6 weeks is back
- The radiation therapy can be obtained as primary therapy (5 x 2 Gy / week up to a total dose of 72-76 Gy)
- Have no restriction on the kidney function.
- No contraindications for the whole-body MRI
- Consent to participate in the study after detailed explanation of previous and written consent

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Exclusion Criteria

- TURP prior to study inclusion
- Pre-irradiation in the pelvic area
- Start an anti-hormonal therapy prior to study entry
- Contraindications to MR studies (pacemakers, metallic clips after magnetizable brain or heart surgery, cochlear implants, metallic foreign body in the eye, insulin pumps, etc.).
- Ferromagnetic intracorporeal debris
- SM / AICD implantation
- Lack of written informed consent
- Combined radiation therapy (HDR afterloading percutaneous)
- Severe allergic diathesis
- Known allergy to contrast agent gadolinium-chelates
- Renal (filtration rate <40 ml / min)
- prior kidney and liver transplant

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Freiburg
    • Mr.  Dr. med.  Hans Christian  Rischke 
    • Robert-Koch-Str. 3
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg
    • Ms.  Prof. Dr.   Ulrike  Fasol 
    • Robert-Koch-Str. 3
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg
    • Mr.  Dr. med.  Hans Christian  Rischke 
    • Robert-Koch-Str. 3
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/12/31
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Trial Publications, Results and other Documents

  • [---]*
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* This entry means the parameter is not applicable or has not been set.