Prostate Cancer
Conditions
Keywords
PSMA, PET/MRI, Prostate cancer, biopsy guidance
Brief 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.
Interventions
DIAGNOSTIC_TESTPSMA-guided and systematic biopsies
Both PSMA-guided and systematic biopsies are performed
Sponsors
Mads Ryo Jochumsen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| High negative predictive value for having csPCa in case of PRIMARY 1-2 (and PI-RADS 1-2) | From enrollment to pathology report, assessed up to 2 years | A high negative predictive value for having csPCa in case of PRIMARY 1-2 (and PI-RADS 1-2) means that biopsies can safely be avoided in patients with PRIMARY 1-2 lesions only. |
Countries
Denmark
Contacts
Primary ContactMads R Jochumsen, MD, Ph.D.
Outcome results
None listed