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

Not Applicable

Conditions: Prostate cancer
C61
Malignant neoplasm of prostate

Registration Number: DRKS00024134

Lead Sponsor: Klinik und Poliklinik für Urologie und Kinderurologie Universitätsklinikum Bonn

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: Male

Target Recruitment: 246

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)

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.