Prostate Embolization for Massive Benign Prostatic Hypertrophy (BPH)

This is a prospective, open labeled, non-randomized, single center feasibility study to
evaluate the technical and clinical success of prostatic artery embolization utilizing
Embosphere microspheres.

At initial consultation patients will be screened to assess the severity of lower urinary
tract symptoms (LUTS) related to BPH utilizing the international prostate symptom score
(IPSS). After determining eligibility, pre-procedure baseline evaluation will be completed. A
baseline prostate ultrasound (TRUS) or MRI will be required to assess prostate mass, and
baseline prostate-specific antigen will be measured to help exclude carcinoma and also to
follow response to therapy. Patients with suspected malignancy of the prostate will not be
enrolled without a negative biopsy finding. Pre- procedure urodynamic studies will be
required to assess additional objective measurements and to exclude other causes of LUTS.
Cystoscopy will be performed prior to any intervention to help exclude bladder malignancy.

If the patient qualifies by the level of symptoms (IPSS score ≥12), prostate size ≥ 90 grams
and max urinary flow rate (Qmax) ≤ 12, the patient will be asked to consider enrolling in the
study. A study investigator will review the proposed treatment and baseline/follow-up
schedule. If the patient agrees to participate in the study, baseline data will be collected
on a case report form and an appointment will be made for prostate artery embolization in the
interventional radiology department.

Inclusion Criteria:

- Patients selected for this study must meet all of the following criteria:

- Age ≥ 50 years

- Lower urinary tract symptoms secondary to BPH as defined by:

- IPSS Symptom Index ≥ 12

- Maximum Uroflow rate (Qmax) of ≤ 12cc per sec

- Prostate of ≥ 90 gm as determined by MRI or transrectal ultrasound of the
prostate (TRUS)

Exclusion Criteria:

- Patients meeting any of the following criteria will be excluded from the study.

- Age less than 50 years

- Prostate cancer

- Bladder cancer

- Severe, life-threatening allergy to iodinated contrast

- Bilateral internal iliac artery occlusion

- Causes of obstruction other than BPH such as stricture disease

- Neurogenic bladder or other causes of bladder atonia

- Post void residual greater than 250 cc

- Any contraindication to embolization, including

- Patients intolerant to occlusion procedures

- Vascular anatomy or blood flow that precludes catheter placement or embolic agent
injection

- Presence or likely onset of vasospasm

- Presence or likely onset of hemorrhage

- Presence of severe atheromatous disease

- Presence of feeding arteries smaller than distal branches from which they emerge

- Presence of collateral vessel pathways potentially endangering normal territories
during embolization

- History of any illness or surgery that might confound the results of the study,
which produces symptoms that might be confused with those of the disease process
under consideration, or which poses additional risk to the patient.

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

- Confirmed or suspected bladder cancer

- Previous rectal surgery (other than hemorrhoidectomy) or history of rectal
disease

- Previous pelvic irradiation or radical pelvic surgery

- Recent (within 3 months) cystolithiasis

- History or presence of urethral strictures, bladder neck contracture, potentially
confounding bladder pathology, or (within 5 years) prostatitis

- Active urinary tract infection

- Concomitant medications:

(i) Use of anti histaminics, anti convulsants, and antispasmodics within 1 week
of treatment unless there is documented evidence that the patient has been on the
same drug dose for at least 6 months with a stable voiding pattern (the drug dose
should not be altered or discontinued for entrance into or throughout the study)
(ii) Use of alpha blockers, anti-cholinergics, androgens, and
gonadotropins-releasing hormonal analogs within 2 months of treatment (iii) Use
of 5 alpha reductase inhibitors within 6 months of treatment

- Compromised renal function (i.e. serum creatinine level greater than 1.8 mg/dl,
or upper-tract disease)