DRKS00024134
Completed
未知
Prospective evaluation of the DEtection rate of clinically significant PROstate cancer by mpMRI and PSMA-PET/CT fusion biopsy - DEPROMP
Klinik und Poliklinik für Urologie und Kinderurologie Universitätsklinikum Bonn0 sites246 target enrollmentJanuary 26, 2021
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Prostate cancer
- Sponsor
- Klinik und Poliklinik für Urologie und Kinderurologie Universitätsklinikum Bonn
- Enrollment
- 246
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
- •patients must be biopsy\-naive
- •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)
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 a site\-specific method)
Outcomes
Primary Outcomes
Not specified
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