SureCore needle: Interim data show longer, less fragmented cores

Despite advances in prebiopsy imaging and lesion targeting, the needle used to obtain prostate tissue has seen little innovation. A multicenter study is now testing whether a redesigned biopsy needle and specimen-handling system deliver better tissue to pathology, according to James S. Wysock, MD.

Prebiopsy magnetic resonance imaging (MRI), MRI-ultrasound fusion targeting, and micro-ultrasound guidance have improved the accuracy of prostate biopsy, but tissue obtained with standard 18-gauge, spring-loaded needles frequently arrived in poor condition, Wysock said. Cores were often fragmented, thin, or incompletely captured by the needle, producing substantial heterogeneity in specimen quality at the final step of an otherwise detailed diagnostic pathway.² Wysock first encountered the SureCore needle at a Focal Therapy Society meeting and pursued an evaluation of it.

The SureCore needle is an 18-gauge handheld device deployed the same way as standard needles, with no change in biopsy technique. Its mechanical difference lies in tissue capture: teeth inside the cannula hold tissue in the chamber as the needle advances, in contrast with the open notch of standard-of-care needles.

“There’s less dragging of the tissue. It gets cut better. It doesn’t stretch the core as much. It doesn’t bunch it up as much,” Wysock said, adding that the result was a larger, more intact core.

Specimen handling after removal presented a second source of tissue damage. Placing cores on a foam pad or dressing before transfer to formalin, as is standard, created opportunities for tissue to fragment, be disrupted, or be lost. With the CoreCare system, the core was placed onto a film that adhered to the tissue within a cassette, preserving its orientation, and the cassette went directly into the specimen jar. Wysock noted that his knowledge of the downstream pathology workflow was secondhand. His understanding was that pathologists received the tissue immediately visible on the film rather than having to search the jar for fragments.

The multicenter study used a paired design focused on MRI-targeted biopsy. For each target, 2 cores were obtained with SureCore and 2 with a standard-of-care needle, with the sequence alternated based on patient date of birth. Pathologists were blinded to the device used for each core. Core length and fragmentation were the primary end points. Standard 12-core systematic template biopsies were also incorporated, generating additional core-level comparisons within each patient. Participating sites performed both transperineal and transrectal biopsies, which Wysock said would improve generalizability, and enrollment was planned for up to 200 men. Eligibility required a Prostate Imaging Reporting and Data System score of 3 or higher and a prostate-specific antigen density greater than 0.15. This enriched the population for cancer to support exploratory analyses, such as the amount of Gleason pattern 4 in grade group 2 or higher disease.

In preliminary results, presented at the Focal Therapy Society Meeting 2026, mean core length was 15 mm with SureCore vs approximately 13 mm with standard needles.

“2 millimeters may not seem like a lot, but remember, 2 millimeters under a microscope is a lot of tissue,” Wysock said.¹ Cores were intact in approximately 87% of SureCore samples vs 72% of standard samples. The effect on cancer detection rates will be assessed once enrollment is complete.

If the findings hold, the technology could address a step in the diagnostic pathway that has seen no major change during Wysock’s career. Because the needle and collection system fit into existing workflow, he anticipated straightforward adoption by urologists already noticing drawbacks with current needles. He expected feedback from pathology colleagues on core quality to reinforce that shift, and urologists considering a change may need to discuss it with their pathologists. Patients undergoing biopsy want the procedure to be as efficient and accurate as possible and generally do not want to repeat it, Wysock said.

Wysock is a urologic oncologist whose practice focuses on prostate cancer diagnostic evaluation, including MRI-targeted prostate biopsy.

REFERENCES

1. Öbek C, Doğanca T, Erdal S, et al. Core length in prostate biopsy: size matters. J Urol. 2012;187(6):2051-2055. doi:10.1016/j.juro.2012.01.075

2. Reis LO, Reinato JAS, Silva DC, et al. The impact of core biopsy fragmentation in prostate cancer. Int Urol Nephrol. 2010;42(4):965-969. doi:10.1007/s11255-010-9720-0