A Novel 3D Navigation Technology for Improved TRUS Prostate Biopsy

he most common method for performing a prostate biopsy procedure is the ultrasound guided transrectal procedure. The information obtained from the standard prostate biopsy is deficient and even misleading. Cancers can be missed on initial and even in repeated biopsy. Moreover, the detection of a tumor cannot predict accurately the tumor size and location1. It was proven that the exact location of the obtained cores, even in an initial biopsy, can influence the cancer detection rate2. An imaging tool that will enable a three-dimensional navigation in the prostate volume and selecting biopsy locations in view of previous core taken will allow building a "tumor map" '(i.e. detecting tumor size and location). By mapping the prostate cancer an adequate treatment can be chosen while avoiding over or insufficient treatment. However, to be able to produce an accurate mapping of the malignant tissue, a complementary optimized pathology method should be also implement in addition to the navigation system, it has been shown that a pre-embedding procedure that keeps the specimen orientation, unfolding, unity, and location along the needle notch improves the histological yield and hence the cancer detection rate3. The NaviGo™ Workstation (hereafter the NaviGo™ Workstation or the NaviGo™ System) allows physicians to see the prostate gland together with the biopsy sites in a three dimensional (3D) view, modeled from two dimensional (2D) images. The NaviGo™ Workstation was designed as an adjunct to standard of care procedures, to work with standard rectal ultrasound probes, and to be incorporated side by side with the techniques currently employed. No change to the current employed procedures and techniques is required or suggested. In complementary to the Navigo system a system for semi-automatic download of prostate biopsy cores which keeps the orientation, unfolding and unity of the sample was developed to increase the pathology utility. The study objective is to evaluate the contribution of the Navigo™ system, an aiding navigation tool for TRUS prostate biopsy, to an increase in the prostate cancer detection ability.

Sex

Male

Minimum age

18 Years

Inclusion Criteria:

* Age 18 years or older
* Planned for trans-rectal prostate biopsy
* Signed informed consent

Exclusion Criteria:

* Patient's unwilling to participate
* Patients with metal prosthetics