Correlation of Imaging Findings With Clinical Findings and Patient Outcomes in Prostate Cancer

The study team hypothesizes that strategic use of advanced MRI methods will provide a more
accurate and less invasive approach for diagnosis and management of prostate cancer. The
primary objectives are:

1. To develop advanced MRI methods and optimal MRI protocols for detection, staging, and
follow-up of prostate cancer.

2. To evaluate the diagnostic performance of MRI-guided biopsy methods and correlate MRI
findings with the pathological grade of cancer.

3. To correlate prostate MRI findings and biopsy results with patient progress and
outcomes.

4. To evaluate the diagnostic accuracy of MRI in disease re-classification in patients on
active surveillance.

Secondary Objectives:

1. To apply computer-aided advanced image analytic techniques (Computer-assisted
diagnostics- CAD) to extract MRI features of patient clinical scans that correlate with
diagnosis and grade of prostate cancer.

2. To study MRI features of lesions that mimic prostate cancer on imaging eg - chronic
prostatitis, post treatment changes.

3. To evaluate the impact of MRI in decision making and choice of treatment by physicians
and patients.

Inclusion Criteria:

- Patients with a suspicion (elevated PSA and/or abnormal digital rectal exam)/
diagnosis of prostate cancer

Inclusion criteria for sub-group follow-up scans:

1a. Patients who have undergone standard TRUS biopsy or TRUS with targeted biopsy (i.e
cognitive TRUS, MR-TRUS fusion or TRUS + in-gantry biopsy)

Exclusion Criteria:

- Patients with ferromagnetic or otherwise non-MRI compatible aneurysm clips.

- The presence of an implanted pacemaker or implanted defibrillator device.

- Patients with contraindications for MRI due to embedded foreign metallic objects.
Bullets, shrapnel, metalwork fragments, or other metallic material adds unnecessary
risk to the patient.

- Implanted medical device not described above that is not MRI-compatible;

- Known history of severe claustrophobia;

- For patients with known history of allergic reaction to magnetic resonance (MR)
contrast material or abnormal kidney function (glomerular filtration rate (GFR) < 30
mL/min), a contrast enhanced exam will not be performed; however, a non-contrast exam
may be performed;

- Minors will be excluded.

- Prisoners and members of other vulnerable populations will be excluded from this study
as these populations will not provide any additional unique information to or uniquely
benefit from the study.