Fusion target biopsy of the prostate using real-time ultrasound and MR images

Completed

• Conditions: Prostate cancer; prostate carcinoma; 10038364; malignancy of the prostate

• Registration Number: NL-OMON44521
• Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 674

Inclusion Criteria

-At least 18 years old and mentally competent
-At least one negative TRUS guided biopsy session (no cancer diagnosis) within the last 4 years
-A PSA value of >4.0 ng/ml and/or suspicious rectal examination

Exclusion Criteria

-Prior diagnosed or treated prostate cancer
-Proven urinary tract infection
-Unwillingness/inability to undergo MRI imaging
-Unwillingness/inability to undergo target biopsy session
-Unwillingness to undergo biochemical follow-up
-Prior target biopsy procedures of the prostate based on MR imaging

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Biopsy cores containing prostate cancer; Gleason score in biopsy cores; number<br /><br>of systematic and target biopsy cores taken.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Occurrence of adverse effects; treatment of adverse effect; duration of biopsy<br /><br>procedure;<br /><br>number of mpMRI suspicious lesions; PI-RADS score of lesions; imaging staging;<br /><br>pathological staging (if prostatectomy follows); imaging<br /><br>modalities/applications used;<br /><br>Baseline characteristics (PSA value; prostate volume; age of subjects; number<br /><br>of previous negative biopsy sessions)<br /><br>Questionnaire scores (EQ5D5L/IPSS/SHIM) </p><br>