Can Needle Size Improve Cancer Detection Rate of Transperineal MRI Target Prostate Biopsy Without Affecting Side Effects?
Recruiting · NCT06420115 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital Padova
View the official record on ClinicalTrials.gov →Interventions studied
different needle size for prostate biopsy
What this trial is about
Differences in terms of diagnostic capability and side effects related to the needle caliber used for prostate biopsy sampling in patients with suspected prostate cancer
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Clinical suspicion of prostate cancer (presence of elevated prostatic specific antigen and/or suspicious digital rectal examination);
- Presence of at least one suspicious prostate lesion on MRI (Prostate Imaging-Reporting and Data System ≥ 3) according to the Prostate Imaging-Reporting and Data System v2.1 performed before Magnetic Resonance Imaging/transrectal ultrasound fusion biopsy.
Exclusion criteria
- Patients under active surveillance or with a previous diagnosis of prostate neoplasia prior to biopsy.
- Previous radiotherapy to the prostate for neoplasia.
Where it is running
1 location listed.
- Urology Unit - Padua University Hospital - Padua, Italy, Italy