PSMA-PET/CT imaging in the EArly detection of Cancer of the Prostate with High Risk Features

Recruiting

• Conditions: 10036958; Malignancy of the prostate; Prostate Cancer

• Registration Number: NL-OMON50089
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

Men * 45 years with no history of PCa and no prior prostate biopsies with
suspected, potentially aggressive PCa due to an elevated PSA-level between 20
and 50 ng/mL are eligible.

Exclusion Criteria

- Previous diagnosis of prostate cancer
- Previous prostate biopsy
- Previous PSMA PET/CT scan

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>OUTCOME MEASURES. It is assessed:<br /><br>1) the (reduced) number of prostate biopsy procedures in the<br /><br>18F-PSMA-diagnostic pathway,<br /><br>2) the (reduced) number of prostate biopsy cores taken,<br /><br>3) the (increased) number of clinically significant (Gleason score 3 + 4 = 7, 4<br /><br>+ 3 = 7,8-10) prostate cancers detected per prostate biopsy session,<br /><br>4) the calculated (reduced) number of complicated urinary tract infections such<br /><br>as urosepsis due to prostate biopsy. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>ND</p><br>