Phase II Investigation of Prostate Artery Embolization (PAE) Before Radical Prostatectomy in Prostate Cancer Patients

Duration of study:

This study will enroll 20 patients, with a target enrollment period of 18 months. Patients
who undergo prostate artery embolization (PAE) will have follow-up visits 2 weeks and 6
weeks after PAE. All patients in the study will have post RALRP follow-up visits at 2 weeks,
3 months, 6 months, 9 months, and 12 months after surgery. All patients will continue to be
followed according to the usual standard of care following the completion of the study.

Study design:

The first 10 patients who meet all study eligibility criteria and provide consent for
participation in the study will receive PAE prior to RALRP. Control patients will be matched
1:1 to PAE patients, according to risk score, and will receive RALRP without PAE. Control
patients will be selected after all PAE patients have been enrolled, and need not meet all
study eligibility criteria.

The following assessments and evaluations are required for participation in this study:

Physical exams, blood & urine tests, magnetic resonance imaging (MRI), digital rectal exams
(DREs), transrectal ultrasound (TRUS), Expanded Prostate Cancer Index Composite (EPIC)
questionnaires, International Index of Erectile Function (IIEF) questionnaires,
robot-assisted laparoscopic radical prostatectomy (RALRP), and pad weight tests. All
patients enrolled in the PAE arm of the study will undergo embolization of the blood vessels
that feed the prostate.

Inclusion Criteria:

- Patient is 45-79 years old

- Patient has signed informed consent

- Patient has biopsy-proven prostate adenocarcinoma with localized disease

- Patient is a candidate for robot-assisted laparoscopic radical prostatectomy (RALRP)

- Patient has a prostate size >40 grams

Exclusion Criteria:

- Active urinary tract infection

- History of life threatening allergy to iodinated contrast agents

- Any known condition that limits catheter-based intervention or is a contraindication
to embolization (eg shunt or adverse arterial anatomy)

- Patient is unable to undergo MRI imaging

- Cardiac condition including congestive heart failure or uncontrolled arrhythmia,
uncontrolled diabetes mellitus, significant respiratory disease, or known
immunosuppression which required hospitalization within the previous 6 months

- Baseline serum creatinine level > 1.8 mg/dL

- Baseline hemoglobin < 8.0 g/dL

- Active cystolithiasis or prostatitis

- History of pelvic irradiation or radical pelvic surgery

- Known major iliac arterial occlusive disease

- Confirmed or suspected bladder cancer

- Urethral strictures, bladder neck contracture, or other bladder or urethral pathology
that could limit catheterization

- Previous rectal surgery (other than hemorrhoidectomy) or history of rectal disease if
the therapy or patient evaluation may potentially cause injury to sites of previous
rectal surgery, e.g. if a transrectal probe is used

- Previous pelvic irradiation or radical pelvic surgery

- Previous prostate surgery, balloon dilatation, stent implantation, laser
prostatectomy, hyperthermia, or any other invasive treatment to the prostate

- Prior transurethral resection of the prostate or other invasive therapies

- Coagulation disturbances not normalized by medical treatment

- Acute urinary retention

- Hypersensitivity to gelatin products

- Any contraindication to embolization, including intolerance to vessel occlusion
procedures, vascular anatomy/blood flow that precludes catheter placement or embolic
agent injection, presence/likely onset of vasospasm, presence/likely onset of
hemorrhage, severe atheromatous disease, feeding arteries smaller than distal
branches, arteriovenous shunt, and collateral vessel pathways endangering normal
territories during embolization or pelvic inflammatory disease