PCMRI - an MRI/TRUS System for the Evaluation of the Prostate
PCMRI - an MRI/TRUS System for the Evaluation of the Prostate
The aim of the clinical study is to evaluate the convenience and efficacy of the PCMRI in the
 assessment of the prostate in humans.

 The study cohort will include 50 patients and is designed to be non-comparative to other
 diagnostic methods.
Prostate cancer (PC) is the most common male malignancy in the western world. In the U.S.
 there are approximately 230,000 new diagnoses annually. Each year, 40,000 men with
 established disease die from PC.

 Early detection is possible using prostate specific antigen (PSA) and/or DRE, followed by
 biopsy if PC is suspected. Biopsy is generally carried out under transrectal ultrasound
 (TRUS) guidance through the rectum wall. Typically, 6-13 samples from different areas of the
 prostate are taken in order to cover the entire gland area. Since TRUS cannot accurately
 detect PC, prostate biopsies, to date, are in fact random biopsies. Furthermore, PSA may be
 elevated, in patients without PC, leading to as many as 75% of patients undergoing
 unnecessary TRUS guided biopsy [1,2].

 The need for accurate preoperative evaluation of PC, as well as early detection of the tumor
 has lead to numerous applications of Magnetic Resonance Imaging (MRI) of the prostate.1 The
 sensitivity and specificity of whole body MRI with pelvic phased-array coils is as low as
 ~70%. Improved sensitivity is obtained using an endorectal coil where efficacies of ~85% are
 reported due to the improved signal to noise ratio (SNR) of such coils.2

 One of the major limitations of conventional MRI scanners is their cost and limited
 availability. A portable, hand-held MR scanner capable of detecting PC is thus, of interest.
 TopSpin has developed a novel MRI based system for prostate imaging in Urology. The primary
 use of the prostate MRI probe will be diagnosis, staging and guidance of minimally invasive
 therapy for PC.

 The system consists of a miniaturized transrectal MRI probe, incorporating all magnetic field
 sources and coils. The MRI probe is integrated with and used in conjunction with a TRUS
 system. The TRUS probe provides prostate gross anatomy and allows the Urologist to select the
 cross-section(s) of interest within the prostate. The MRI probe provides MRI images of the
 selected cross-section(s) with improved tissue characterization that enable localizing tumors
 within the prostate. Fusion of both images has promise of significantly improving the ability
 to direct biopsies to regions of a much higher likelihood for being malignant. In addition,
 the system is capable of guiding local treatment such as Cryotherapy or Brachytherapy.

 The integrated MRI-TRUS system resembles a state-of-the-art, high-end ultrasound system. The
 MR-TRUS probe is connected to a cart based console, which houses the electronics hardware
 required for both MR and ultrasound activation. An investigational device will be
 manufactured, handled, and stored in accordance with applicable good manufacturing practice
 (GMP). It will be used in accordance with the approved protocol. Procedures that assure the
 quality of every aspect of the trial will be implemented.
Inclusion criteria for trial group:

 -  Age between 45 and 80 years old.

 -  Presumably Stage 2 and higher prostate carcinoma as determined by the PI.

 -  At least 6 weeks after the last biopsy session.

 -  Prior to any PC treatment. for control group:

 -  Age between 25 and 35 years old.

 -  No family history of PC.

 -  No lower urinary tract symptoms. Exclusion criteria for both groups:

 -  History of hemorrhoids.

 -  History of prostetitis