Trial document





This trial has been registered retrospectively.
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  DRKS00003469

Trial Description

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Title

Detecting local recurrent prostate cancer: MRI:patterns of post-prostatectomy recurrence and of its response to salvege radiotherapy using Enhanced and Dynamic Contrast Enhanced (DCE) MRI

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

We retrospectively analyze patterns of local recurrence in contrast-enhanced MRI images in patients with recurrent prostate carcinomas who had undergone radical prostatectomy. The goal is to gain more accurate information on recurrence pattern, localization of local recurrence and detectability depending on its size and the PSA level.

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Brief Summary in Scientific Language

We retrospectively analyze patterns of local recurrence in contrast-enhanced MRI images in patients with recurrent prostate carcinomas who had undergone radical prostatectomy. We use MRI scans, which were made as part of routine diagnostics for staging before and after salvage radiotherapy. We study the scans for presence of suspicious tumor lesions, especially gadolinium enhancing nodules in the prostatic fossa. Correlation to PSA will be performed to estimate the sensitivity of the MRI scan. To determine the specificity, the response of serum PSA after salvage radiotherapy and follow up MRI scans are used. The goal is to gain more accurate information on recurrence pattern, localization of local recurrence and detectability depending on its size and the PSA level.

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Organizational Data

  •   DRKS00003469
  •   2012/11/21
  •   [---]*
  •   yes
  •   Approved
  •   112/11, 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

  •   Evaluation of patient data regarding the median PSA, the T stage, Gleason score before radical prostatectomy and after surgical resection.
    Evaluation of the patient data on the median age at diagnosis of recurrence, the median level of the PSA at the time of collective diagnosis of recurrence.
    Median time interval between the MRI scan before radiation therapy to radical prostatectomy.
    Evaluation of the number, the size and volume of conspicuous lesions on MRI before radiotherapy.
    Time course of the serum PSA level within the first 12 months after radiotherapy.
    Of the correlation between local recurrence-size or volume and PSA level before radiotherapy. Calculating the correlation coefficients.
    Evaluation of any existing MRI follow-up examinations after radiotherapy and compared them with MRI scans before radiation therapy.
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Characteristics

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

Sensitivity, specificity and accuracy of DCE-MRI without endorectal coil in the detection of local recurrent PC at very low PSA levels.

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Secondary Outcome

Correlation of tumor size to pre-RT PSA-level.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2011/03/24
  •   33
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

- Patients with a history of prostate carcinoma Prostatavesikolektomie because of a biochemical (PSA) recurrence (definition of PSA recurrence: three consecutive rising PSA values ‚Äč‚Äčabove the nadir,> 3 months after surgery)
- Have received no anti-hormonal therapy prior to radiotherapy
- MRI scan prior to initiation of radiotherapy
- PSA follow-up of at least 1 year after the end of radiotherapy

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Exclusion Criteria

Clinical and imaging suspicion of lymph node metastases or distant metastases before initiation of radiation therapy to the pelvis

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
    • Mr.  Dr. med.  Hans Christian  Rischke 
    • Robert-Koch-Str. 3
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
    • Mr.  Dr. med.  Hans Christian  Rischke 
    • Robert-Koch-Str. 3
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg, Klinik für Strahlenheilkunde
    • Mr.  Dr. med.  Hans Christian  Rischke 
    • Robert-Koch-Str. 3
    • 79106  Freiburg
    • Germany
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    end of 1:1-Block address contact public-contact
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Sources of Monetary or Material Support

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    • Universitätklinikum Freiburg, Klinik für Strahlenheilkunde
    • Robert-Koch-Str. 3
    • 79106  Freiburg
    • Germany
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2011/06/30
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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.