Comparing needle sizes for better prostate cancer detection
AOP2780 - Can Needle Size Improve Cancer Detection Rate of Transperineal MRI Target Prostate Biopsy Without Affecting Side Effects?
This study tests whether using a bigger needle for prostate biopsies helps find cancer better than using a smaller needle for men who might have prostate cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 580 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Padova Academic / other |
| Locations | 1 site (Padua, Italy) |
| Trial ID | NCT06420115 on ClinicalTrials.gov |
What this trial studies
This study evaluates whether using a larger caliber (16G) needle for transperineal MRI-targeted prostate biopsies improves the detection rate of prostate cancer compared to a smaller caliber (18G) needle. The research focuses on assessing the diagnostic capabilities of each needle size while monitoring for any differences in side effects or complications. Patients with suspected prostate cancer will undergo biopsies using both needle sizes to determine which is more effective in identifying cancerous lesions.
Who should consider this trial
Good fit: Ideal candidates are men with clinical suspicion of prostate cancer and at least one suspicious lesion identified on MRI.
Not a fit: Patients who are under active surveillance or have a prior diagnosis of prostate cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prostate cancer detection rates, allowing for earlier and more accurate diagnosis.
How similar studies have performed: Other studies have explored needle sizes in prostate biopsies, but this specific comparison of 16G versus 18G is less common, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Padua, Italy
- Urology Unit - Padua University Hospital — Padua, Italy, Italy (Recruiting)
Study contacts
- Principal investigator: Fabio Zattoni, MD, PhD — Department of Surgery, Oncology and Gastroenterology, Urology Clinic, University of Padua, Padova,
- Study coordinator: Fabio F. Zattoni, MD, PhD
- Email: fabio.zattoni@unipd.it
- Phone: 0498212730
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.