Trial document




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  DRKS00024134

Trial Description

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Title

Prospective evaluation of the DEtection rate of clinically significant PROstate cancer by mpMRI and PSMA-PET/CT fusion biopsy

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Trial Acronym

DEPROMP

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URL of the Trial

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Brief Summary in Lay Language

In our research project we want to investigate of a novel combined diagnostic test in patients with suspected prostate cancer including the gain in information and its effects on the further course of treatment. The primary aim of the study is to improve the risk stratification before treatment of prostate cancer; in particular, the focus is on improving the assessment of tumor burden (aggressiveness and localization) and possible resulting improvements of treatment.

Although there are already promising test results regarding the use of PSMA-PET/CT in primary diagnosis of prostate cancer, it has not yet been possible to systematically evaluate these in everyday clinical practice. With this study we want to investigate the short and medium-term effects of additional imaging using PSMA-PET/CT and additional biomarker determination in prostate tissue on the detection and treatment of prostate cancer.

After successful study-specific PSMA-PET/CT and guideline-compliant mpMRI of the prostate, the additional benefit of PSMA-PET/CT-mpMRI ultrasound-guided prostate biopsy is evaluated. The samples obtained with the help of targeted tissue sampling are examined for biological molecules that could be used in the future to predict the course of the disease (biomarkers).

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Brief Summary in Scientific Language

In patients with suspected localised prostate cancer, the extent and aggressiveness of the tumour is determined using standard clinical (digital-rectal examination), laboratory chemical (PSA value determination) and image morphological (transrectal ultrasound, multiparametric MRI of the prostate and PSMA-PET/CT) procedures.

An ultrasound-guided mpMRI-PSMA-PET/CT fusion biopsy is then performed specifically for the study: Under ultrasound control, twelve systematic tissue samples of the outer region of both lateral prostate lobes are obtained first. In addition, targeted tissue samples are taken from the areas classified as suspicious in mpMRI and PSMA-PET/CT. The biopsy is performed after fusion of the MRI or PSMA-PET/CT image with the ultrasound image. The biopsies are histopathologically processed and examined for the presence of prognostic biomarkers (PTEN, PSMA).

Furthermore, risk stratification and therapy planning is based on biopsy results including tumour volume, tumour aggressiveness and biomarker determination. Here, changes in therapy algorithms are analysed depending on the modified accompanying diagnostics before the prostate biopsy.

If a prostatectomy is performed, the risk stratification of mpMRI-PSMA-PET/CT fusion biopsy is validated by a comparative analysis of the exact tumour extent and aggressiveness as well as biomarker determination in whole-mount sectioning prostatectomy preparation.
Further carcinoma-specific therapy measures and PSA-values are monitored postinterventionally over 24 months.

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

No

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Description IPD sharing plan:

Passing on the data to third parties who are not involved in the direct study process or in the publication of the data in medical journals is not provided in clinical study protocol. In addition, even if data rights clearly lie with us, new project ideas may be generated from the monocentric study data, which the applicant himself would develop as a matter of priority. After interim evaluation, it will be made a decision on dissemination of the data again.

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Organizational Data

  •   DRKS00024134
  •   2021/01/26
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  •   yes
  •   Approved
  •   150/20, Ethik-Kommission der Medizinischen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn
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Secondary IDs

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Health Condition or Problem studied

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

  •   - PSMA-PET/CT for diagnosis and therapy planning in localised prostate carcinoma
    - PSMA-PET/CT fusion biopsy in case of additional suspicious areas
    - Biomarker determination PTEN, PSMA in the biopsies, large area sections, lymph node metastases
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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)
  •   N/A
  •   N/A
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Primary Outcome

Optimising patients risk stratification with localised prostate cancer to improve therapy planning.

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Secondary Outcome

The combined use of PSMA-PET/CT in addition to standard procedure with mpMRT and histopathology is particularly aimed at increasing the detection rate of clinically significant cancer during prostate biopsy.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2021/03/25
  •   230
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   45   Years
  •   75   Years
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Additional Inclusion Criteria

• The patient is suspected of having a localised prostate carcinoma based on at least one of the following criteria, so that clarification by means of MRI fusion punch biopsy is indicated:
PSA-value ≥ 4 ng/ml or
suspicious tactile findings of the prostate in the digital rectal examination or
suspicious findings in transrectal sonography
• patients must be ≥ 45 years and < 76 years old
• patient gives documented written consent to participate in the study
• patients who are able to follow the study instructions and who are likely to adhere to all required study visits (compliance)

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Exclusion Criteria

• The patient has a PSA level elevation of >100 ng/ml with resulting suspicion of advanced metastatic prostate carcinoma
• The patient has a serious kidney disease, defined by Estimated creatinine clearance < 30 ml/min (using Cockcroft-Gault formula based on current body weight)
• The patient has a thyroid dysfunction, defined by TSH ≤ 0.51 or ≥ 4.3 μU/ml

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Addresses

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    • Klinik und Poliklinik für Urologie und Kinderurologie Universitätsklinikum Bonn
    • Mr.  Dr. med.  Philipp  Krausewitz 
    • Venusberg-Campus 1
    • 53127  Bonn
    • Germany
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    • Klinik und Poliklinik für Urologie und Kinderurologie Universitätsklinikum Bonn
    • Mr.  Dr. med.  Philipp  Krausewitz 
    • Venusberg-Campus 1
    • 53127  Bonn
    • Germany
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    • Klinik und Poliklinik für Urologie und Kinderurologie Universitätsklinikum Bonn
    • Mr.  Dr. med.  Philipp  Krausewitz 
    • Venusberg-Campus 1
    • 53127  Bonn
    • Germany
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Sources of Monetary or Material Support

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    • Förderinstrument für klinische Studien der Medizinischen Fakultät der Universität Bonn
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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