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

Mads Ryo Jochumsen

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Diagnostic Test: PSMA-guided and systematic biopsies

Study type: Interventional

Funder types: Other

Identifiers

NCT07258056

1-10-72-109-25

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• PSAdensity > 0.20
• Negative MRI (PI-RADS 1-2) or negative biopsy from MRI-target
• MRI within 6 months
• Read and understand danish
• Expected remaining lifetime > 10 years

Exclusion criteria

• Known prostate cancer
• MRI contraindications

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

PSMA-guided and systematic biopsies

Experimental group

Description:

Both PSMA-guided and systematic biopsies are performed

Treatment:

Diagnostic Test: PSMA-guided and systematic biopsies