Optimizing prostate biopsy techniques for cancer detection
Identifying the Optimal Biopsy Scheme at MRI Target Biopsy
NA · IRCCS San Raffaele · NCT04183699
This study is testing how many biopsy samples are needed during an MRI-guided prostate biopsy to see if fewer samples can still effectively find prostate cancer in men who are suspected of having it.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 265 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Male |
| Sponsor | IRCCS San Raffaele (other) |
| Locations | 1 site (Milan) |
| Trial ID | NCT04183699 on ClinicalTrials.gov |
What this trial studies
This multicenter, paired-cohort, prospective, controlled study aims to determine the optimal number of systematic biopsy cores needed during an MRI-targeted biopsy for patients suspected of having prostate cancer. Participants will undergo an MRI-targeted biopsy followed by systematic sampling to compare the cancer detection rates between different core sampling strategies. The study hypothesizes that fewer systematic cores can effectively detect clinically significant prostate cancer, potentially streamlining the biopsy process. The same operator will perform all procedures to ensure consistency in technique and results.
Who should consider this trial
Good fit: Ideal candidates are male patients aged 18 to 80 with a suspicion of prostate cancer and a positive mpMRI showing a lesion with a PI-RADS score of 3 or higher.
Not a fit: Patients with prior positive prostate biopsies or those with multiple lesions on mpMRI may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more efficient prostate cancer detection methods, reducing the number of biopsy cores needed and minimizing patient discomfort.
How similar studies have performed: While similar approaches have been explored, this specific optimization of systematic cores in conjunction with MRI-targeted biopsies is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male patients, aged between 18 and 80 years old with suspicion of prostate cancer * Presence of a positive mpMRI of the prostate (visible lesion PI-RADS ≥ 3) * Serum PSA ≤ 20ng/ml * Suspected stage ≤ T2 on rectal examination (organ confined prostate) * Fit to undergo a prostate biopsy * Able to understand and willing to sign a written informed consent document Exclusion Criteria: * Prior positive prostate biopsy * Prior treatment of the prostate * Prostate volume \<30 ml at mpMRI of the prostate * More than one lesion at mpMRI of the prostate * Contraindication to prostate biopsy
Where this trial is running
Milan
- IRCCS San Raffaele — Milan, Italy (RECRUITING)
Study contacts
- Study coordinator: Armando Stabile
- Email: stabile.armando@hsr.it
- Phone: +390226435660
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.
Conditions: Suspicion of Prostate Cancer With a Positive Multiparametric Magnetic Resonance of the Prostate