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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00024134
Enrollment
230
Registered
2021-01-26
Start date
2021-03-25
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer C61

Interventions

Group 1: - 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

Sponsors

Klinik und Poliklinik für Urologie und Kinderurologie Universitätsklinikum Bonn
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
45 Years to 75 Years

Inclusion 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

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)

Design outcomes

Primary

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

Secondary

MeasureTime frame
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.

Countries

Germany

Contacts

Public ContactPhilipp Krausewitz

Klinik und Poliklinik für Urologie und Kinderurologie Universitätsklinikum Bonn

philipp.krausewitz@ukbonn.de0228/287-12610

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026