18F-PSMA-1007 PET to detect primary prostate cancer: a comparative study with mpMRI and correlation to histopathology

Phase 2

Completed

Conditions: Prostate cancer
prostate malignancy
10027656

Registration Number: NL-OMON49534

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 75

Inclusion Criteria

- Suspicion for prostate cancer (e.g. elevated PSA, suspicious rectal
examination)
- Males >= 18 years

Exclusion Criteria

- Prostate biopsy in the last 6 months
- History of prostate cancer
- Second active malignancy
- Contra-indications for mpMRI or PET: claustrophobia or inability to lay still
for the duration of the exam.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Within each of the three PIRADS groups (1-2, 3, 4-5) the fraction of patients<br /><br>in which the diagnosis based on mpMRI and 18F-PSMA PET might differ. For<br /><br>patients that have conflicting imaging outcomes, the imaging results are<br /><br>compared with the results of the (target) biopsy.<br /><br>Secondary endpoints will be the radiological state of the disease expressed in<br /><br>the difference in number and size of suspicious lesions, the extent of the<br /><br>disease on 18F-PSMA PET and mpMRI, correlation of the standardized uptake value<br /><br>of the PET to the PSMA expression of the immune-histopathology of the biopsy<br /><br>(e.g. ISUP score). Another explorative endpoint is to perform a<br /><br>cost-effectiveness analysis for the additional use of 18F-PSMA PET based on the<br /><br>final findings.</p><br>

Secondary Outcome Measures