Transforming prostate cancer diagnosis: Feasibility testing of a novel system for integrated endorectal MRI and in-bore biopsy

PROJECT ABSTRACT The development of the novel OmnEcoil system aligns with the NCI’s mission to help people live longer, healthier lives by providing a faster, more efficient, and more accurate diagnostic test for the estimated 1.4 million men who develop prostate cancer each year. The OmnEcoil system consists of a disposable 20 cm long endorectal coil and multichannel needle guide with a reusable clamp stand, embedded electronics, and baseplate. This dynamic, innovative system can work with any standard MRI scanner, and can be used by radiologists or urologists to perform endorectal MRI and in-bore MRI targeted biopsy of the prostate as a single procedure. The goal of this STTR project is to take the system from the current tested laboratory prototype through a feasibility study. The hypothesis that OmnEcoil will allow endorectal MRI and in-bore MRI targeted biopsy of the prostate in one procedure, with comparable performance to single channel in-bore MRI-targeted biopsy will be tested via the following aims: 1) confirm that the OmnEcoil system allows for endorectal imaging and in-bore targeted biopsy; and 2) investigate the cancer detection rate for the OmnEcoil system. The investigators will recruit 30 men with a suspicious target on MRI (PI-RADS score of 4 or 5) but no significant cancer (prior TRUS biopsy negative or Gleason score 6 cancer only) to undergo endorectal MRI with MRI- guided biopsy using the OmnEcoil system in an IRB and IDE approved study at our partner research institution, Oregon Health and Science University (OHSU). Success will be defined as the acquisition of diagnostic tissue samples, as determined by pathological review establishing if the samples are adequate or inadequate for diagnosis. For cancer detection, investigators will measure the percentage of cancer containing biopsies of suspicious targets. Results are anticipated to show the OmnEcoil system allows for combined imaging and biopsy of suspected cancer sites in the prostate with comparable performance to single-channel in-bore biopsy, the best currently available approach. These results would provide sufficient evidence of clinical feasibility to justify continued product development as well as a Phase II single-arm multicenter pivotal trial of 150 subjects to demonstrate clinical effectiveness. The commercial opportunity is promising with a submarket of 12,500 repeat biopsy procedures per year. At a price of $1000 per disposable unit, this yields a Serviceable Obtainable Market in the U.S. of $12.5M and an annual global market as $4B. Initial customers for the OmnEcoil system will be radiologists at U.S. academic centers, working collaboratively with their institutional urology colleagues.