Prospective Assessment of Image Registration for the Diagnosis of Prostate Cancer
Prospective Assessment of Image Registration for the Diagnosis of Prostate Cancer
This is a pilot study to determine cancer detection rate of conventional/systematic versus
 targeted biopsy methods in diagnosis of potentially lethal prostate cancer. This is a
 diagnostic trial using each patient as his own control.
Each biopsy session would be preceded by mpMRI, which would be delineated and assigned a
 degree of suspicion by a radiologist (see above).The PI-RADS scoring system will be used to
 assign a degree of suspicion to regions of interest within the prostate. A second reader will
 independently score the RSI on a Likert scale, blinded to the other MRI data. The regions of
 interest will be delineated using software developed by Eigen in collaboration with a study
 co-author (D.M.), now commercially available and in use by the UCLA team for the past 2 years
 (ProFuse, Eigen).The RSI data will be integrated with the standard mpMRI data and any change
 in scoring or presence of additional lesions, determined by RSI, will be quantified. For men
 with a MR-visible target of PI-RADS score 3 or more, irrespective of RSI score, the biopsy
 session would then proceed in an ordered routine, as follows:

 1. Conventional ultrasound-guided 12-core systematic biopsy would be performed first. This
 portion will be performed without operator knowledge of the MRI report, i.e., the
 urologist will be blinded to possible tumor location and use the method in standard
 practice throughout the U.S. for many years.

 2. Next a targeted biopsy would be performed using visual guidance (cognitive fusion),
 under the supervision of a radiologist specializing in prostate MRI. The radiologist
 will be in the biopsy suite and help the urologist direct needle at location of region
 of interest in the prostate seen on MRI. Three directed biopsy cores will be obtained.

 3. Third, a targeted biopsy using Artemis device fusion of MRI and ultrasound images would
 be performed. The prostate will be scanned and the MRI region of interest (target)
 brought into the 3D model via device fusion. Targeted biopsy will be performed by taking
 three cores of tissue from the target area, visualized as a 3D region in the fusion
 device.

 Biopsy sites to be dictated by geometric guides (12 point pattern vs visual direction of
 radiologist vs fusion target), not chosen arbitrarily.

 The above biopsy schema will not require any more procedure time or samples taken than fusion
 biopsy as performed under IRB approval at our institution for the last five years. Additional
 cores will be required for the visual biopsy method, but no biopsy cores will be obtained
 from secondary targets. Most patients exhibit secondary targets. An analysis of data from
 past 2 years demonstrated that the chance of a secondary target showing significant cancer,
 not present in a primary target, is less than 1%. Therefore, secondary targets will not be
 sampled, as cores are instead taken from primary targets using the two methods. In 200 men
 undergoing initial biopsy, an average of 17 +/- 3 S.D. cores/patient has been obtained. In
 the present proposal, 18 cores will be taken. Thus, the number of cores/patient in this trial
 will not substantially exceed the number that has been routinely taken in our practice in the
 past.

 A sampling method of three directed cores per target was chosen as a compromise between what
 is clinically feasible and a statistical ideal of taking additional cores for significant
 cancer detection in lower grade targets.

 The cognitive biopsy will require approximately 90 seconds of additional time, but this added
 time will be more than compensated by the reduced time obtained from excluding secondary
 targets. The overall biopsy schema should require no more (and probably less) than the 15-20
 minutes/procedure as in the past. Biopsies will be performed by an experienced team, which
 has been working together since 2009.
Inclusion Criteria:

 -  Men undergoing a first-time prostate biopsy driven by PSA elevation to rule out
 cancer.

 -  PSA 2.5 - 20 ng/mL

 -  Prostate volume 20 - 100 cc

 -  No prior ablation or TURP

 -  Able to tolerate MRI

 -  T1c suspect

 -  Signed informed consent

 Exclusion Criteria:

 -  Any prior prostate biopsy

 -  Active bleeding disorder or concurrent use of coumadin or any other anticoagulant,
 unless anticoagulation can be temporarily stopped for at least 7 days before and 7
 days after the biopsy

 -  Any prostate ablative procedure, including transurethral resection, photovaporization,
 or electrovaporization

 -  Any contraindication to MRI (contrast allergy, severe claustrophobia, MRI-incompatible
 prosthesis) ,

 -  Palpable prostate mass lesion (i.e., Stage >T1c suspected)

 -  Any condition that would preclude the subject from getting the required biopsy as
 stated in the protocol