GUidance In Prostate Cancer DEtection With 18F-PSMA-1007-PET/MRI and Targeted Biopsies

Condition(s) studied

Investigational drug(s) / intervention(s)

PSMA-guided and systematic biopsies: Both PSMA-guided and systematic biopsies are performed

Study summary

The goal of this clinical study is to test the performance of PSMA PET/MRI-guided biopsies against systematic biopsies in men with negative MRI scan (PI-RADS 1-2) of the prostate with continuous suspicion of clinically significant prostate cancer (csPCa) due to PSAd \> 0.20. The main questions it aims to answer are:

Can biopsies safely be avoided at PRIMARY score 1-2 without missing csPCa? Does targeted PSMA PET/MRI-guided biopsies have a higher detection rate of csPCa compared to systematic biopsies?

Participants will undergo both transperineal MRI/ultrasound fusion target biopsies from PRIMARY score 3-5 lesions on PSMA PET and systematic biopsies irrespective of the PRIMARY-lesion.

Eligibility

Primary outcome measure(s)

• Detection rate of clinically significant prostate cancer (csPCa) for PSMA guided biopsies vs systematic biopsies — From enrollment to pathology report is ready, assessed up to 2 years
  CsPCa is defined as "International Society of Urological Pathology" (ISUP) grade ≥ 2. The ISUP grade scale ranges from 1 to 5, where grade 1 is low-risk / indolent / non-significant prostate cancer and grade 5 is the most aggressive prostate cancer form with worse outcome.

Trial sites (2)

Other trials for the same condition