Active surveillance (AS) is becoming more accepted as a reasonable treatment option for men with low-risk prostate cancer (i.e. Gleason score 6, clinical stage T2a, PSA <10). Many AS protocols at major institutions call for a prostate saturation biopsy after initial diagnosis to confirm that the patient has no areas of higher-risk prostate cancer. For most patients who underwent prostate biopsy recognize it as a painful and lengthy procedure with an uncertain diagnosis due to limited accuracy. The biopsy needle devices for prostate biopsy in clinic are not optimal. To more completely sample all regions of the prostate prior to initiating AS, a transperineal approach prostate core biopsy is commonly performed. This research integrates five innovative techniques, all proven feasible individually, to a High-yield and Accurate template-guided Transperineal saturation Biopsy (HATB) system. An end-cut biopsy needle tip with high inclination angle cutting edge, the high and instant suction vacuum inside the needle created by retracting the stylet at a high speed, polished needle internal surface to reduce friction, and optimal needle speed are applied to increase the tissue length in needle biopsy. Using the 18 gage needle common for prostate biopsy, HATB can consistently acquire 40 to 50 mm long tissue sample in each pass. HATB system can acquire biopsy sample across the entire length (apex, mid and base) of the prostate in one needle insertion via the transperineal template-guided technique. The needle with high stiffness tungsten carbide stylet, optimal insertion speed, and perineal template with precision holes can reduce the deflection plaguing current needle systems. We have previously demonstrated the feasibility of these six innovations in preliminary product development tests and will integrate them into the HATB system. This product will have a significant impact on those patients with prostate cancer who are eligible for AS through a more accurate, less traumatic and safer saturation prostate biopsy technique. It will also impact Urologists to better diagnose prostate cancer by increasing the accuracy of the prostate biopsy procedure to gain more exact clinical staging of a patient's disease, leading to more appropriate treatment choices, and ultimately improving prostate cancer oncologic outcomes and reducing treatment costs.
This research develops the high-yield prostate needle biopsy device with the goal to improve the accuracy of diagnosis and reduce the number of needle passes, procedure time, and complication by consistently acquiring long, contiguous tissue samples across the whole prostate gland.