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25 Years
80 Years
Not Enrolling
Prostate Cancer

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Trial Information

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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Efficacy of the PCMRI system in PC detection

Outcome Time Frame:

one year

Principal Investigator

Shmuel Cytron, MD.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Barzilai Medical Center, Ashkelon, Israel


Israel: Ethics Commission

Study ID:




Start Date:

November 2007

Completion Date:

November 2008

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms