FindTrial
Sign In

Comparison of transperineal MRI/Ultrasound-fusion biopsy oft he prostate to transrectal ultrasound guided biopsy with elastography, color sonography and contrast enhanced ultrasound in the detection of prostate cancer in men with prior negative prostate biopsy

Comparison of transperineal MRI/Ultrasound-fusion biopsy oft he prostate to transrectal ultrasound guided biopsy with elastography, color sonography and contrast enhanced ultrasound in the detection of prostate cancer in men with prior negative prostate biopsy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00009407
Enrollment
240
Registered
2015-11-13
Start date
2015-11-16
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

C61

Interventions

Group 1: transperienal MRI/ultrasound-fusion biopsy Group 2: transrectal systematic biopsy with multiparmetric ultrasound (grey scale ultrasound, doppler ultrasound, elastography, contrast-enhanced ul

Sponsors

Klinik und Poliklinik für UrologieUniversitätsklinikum Carl Gustav Carus
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
40 Years to 75 Years

Inclusion criteria

Inclusion criteria: - Age > 40, = 75 years; - PSA > 3,0ng/ml; - At least one prior negative prostate biopsy, - no contraindications for mpMRI - no contraindications for the application of ultrasound contrast agent (SonoVue; Fa. Bracco) - signed consent form

Exclusion criteria

Exclusion criteria: Known prostate cancer

Design outcomes

Primary

MeasureTime frame
Proportion of men diagnosed with clinically significant cancers defined by Gleason Score = 3+4=7 by all biopsy methods (MRI/ultrasound-fusion biopsies vs. standard biopsies alone and in combination with targeted biopsy in multiparametric ultrasonography).—

Secondary

MeasureTime frame
- proportion of men with diagnosed prostate cancer with a Gleason Score >= 6 in MRI/Ultrasound-fusion biopsy vs. Targeted biopsy in multiparametric ultrasonography vs. Systematic biopsy - overall detection rate in all three methods - proportion of prostate cancer (Gleason Score >=6 and >= 3+4) in MRI lesions with PIRADS >=3 - proportion of positive cores in all three methods overall and separately - proportion of positive cores with clinically significant cancer in all three methods - proportion of lesions in mpMRI with PIRADS>=2 without tumour detection - proportion of lesions in multiparametric ultrasonography with and without tumour detetction - detection of prostate cancer Gleason score >=6 in multiparametric ultrasonography - correlation of stiffness and ratio of stiffness in elastography with tumour detection rate and tumour aggressivenenss - correlation of the grade of perfusion in doppler ultrasound and contrast enhanced ultrasound—

Countries

Germany

Contacts

Public ContactAngelika Borkowetz

Klinik und Poliklinik für UrologieUniversitätsklinik Dresden

angelika.borkowetz@unilinikum-dresden.de0351-458-18244

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026