Prostate Artery Embolization With Embosphere Microspheres Compared to TURP for Benign Prostatic Hyperplasia



Status:Terminated
Conditions:Hematology, Benign Prostate Hyperplasia, Urology
Therapuetic Areas:Hematology, Nephrology / Urology
Healthy:No
Age Range:50 - 79
Updated:12/29/2017
Start Date:July 2013
End Date:December 2017

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Prospective, Controlled Investigation of Prostate Artery Embolization With Embosphere Microspheres Compared to Transurethral Resection of the Prostate for the Treatment of Symptomatic Benign Prostatic Hyperplasia

The purpose of this study is to evaluate improvement of symptoms from benign prostatic
hyperplasia (BPH) as assessed by the International Prostate Symptom Score (IPSS) for
prostatic artery embolization (PAE) using Embosphere Microspheres compared to conventional
transurethral resection of the prostate (TURP).


Inclusion Criteria:

1. Patient is age 50 to 79, inclusive

2. Patient has signed informed consent

3. Patient has had lower urinary tract symptoms (LUTS) secondary to BPH for at least 6
months prior to study treatment

4. Patient has a baseline IPSS Score > 13 at baseline

5. Patient has a prostate size of at least 50 grams and not more than 90 grams, measured
by MRI

6. Patient has BPH symptoms refractory to medical treatment or for whom medication is
contraindicated, not tolerated or refused

7. Patient must be a candidate for TURP

8. Patient must meet ONE of the following criteria:

- Baseline Prostate Specific Antigen (PSA) <2.5 ng/mL (no prostate biopsy required)

- Baseline PSA >2.5 ng/mL and ≤10 ng/mL AND free PSA > 25% of total PSA (no
prostate biopsy required)

- Baseline PSA >2.5 ng/mL and ≤10 ng/mL AND free PSA < 25% of total PSA AND a
negative prostate biopsy result (minimum 12 core biopsy)

- Baseline PSA >10 ng/mL AND a negative prostate biopsy (minimum 12 core biopsy)

Exclusion Criteria:

1. Active urinary tract infection

2. Biopsy proven prostate or bladder cancer, or any cancer other than basal or squamous
cell skin cancer

- The following patients must undergo prostate biopsy with a minimum of 12 cores
and have a negative histopathology report to be enrolled in the study:

- Patients with digital rectal examination (DRE) findings suspicious for
prostate cancer

- Patients with baseline PSA levels > 10 ng/mL

- Patients with baseline PSA levels >2.5 ng/mL and < 10ng/mL AND free PSA <
25% of total PSA

- Patients with cystoscopy findings suspicious for bladder cancer must undergo
biopsy and have a negative histopathology report to be enrolled in the study

3. Bladder atonia, neurogenic bladder disorder or other neurological disorder that is
impacting bladder function (eg multiple sclerosis, Parkinson's disease, spinal cord
injuries, etc)

4. Urethral stricture, bladder neck contracture, sphincter abnormalities, urinary
obstruction due to causes other than BPH, or other potentially confounding bladder or
urethral disease or condition

5. Patient has taken beta blockers, antihistamines, anticonvulsants, or antispasmodics
within 1 week of study treatment AND has not been on the same drug dosage for 6 months
with a stable voiding pattern

• Dosage of these medications should not change during study participation unless
medically necessary

6. Patient has taken antidepressants, anticholinergics, androgens or
gonadotropin-releasing hormonal analogues within 2 months of study treatment AND has
not been on the same drug dosage for at least 3 months with a stable voiding pattern

7. Patient has taken 5-alpha reductase inhibitors or alpha blockers within 1 month of
study treatment AND has not been on the same drug dosage for at least 3 months with a
stable voiding pattern

8. Previous non-medical BPH treatment, including surgery, TURP, needle ablation,
microwave or laser therapy, balloon dilation, stent implantation, or any other
invasive treatment to the prostate

9. Any known condition that limits catheter-based intervention or is a contraindication
to embolization, such as intolerance to a vessel occlusion procedure or severe
atherosclerosis.

10. Patient is unable to stop taking anticoagulant, nonsteroidal antiinflammatory drug
(NSAID) or anti-platelet therapy for 7 days prior to study treatment

11. Unable to have MRI imaging (eg metal implant including pacemaker, replacement joint,
etc)

12. Patient has an asymmetric prostate, with > 20% difference in size between lobes

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

14. Baseline serum creatinine level > 1.8 mg/dl

15. Known upper tract renal disease

16. Cystolithiasis or chronic hematuria within 3 months prior to study treatment

17. Active prostatitis

18. Previous rectal surgery other than hemorrhoidectomy, or history of rectal disease

19. History of pelvic irradiation or radical pelvic surgery

20. Patient is interested in future fertility

21. Coagulation disturbances not normalized by medical treatment

22. Acute urinary retention requiring an indwelling catheter

23. Known major iliac arterial occlusive disease

24. Allergy to iodinated contrast agents

25. Hypersensitivity to gelatin products
We found this trial at
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1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Phone: 212-824-7877
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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Baltimore, Maryland 21231
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4725 North Federal Highway
Fort Lauderdale, Florida 33308
(954) 771-8000
Principal Investigator: Michael Rush, MD
Holy Cross Hospital While spirituality plays an essential role in the way that we minister...
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1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
Principal Investigator: Clifford Davis, MD
Phone: 813-844-5012
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
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Long Beach, California 90822
Phone: 714-456-8148
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Los Angeles, California 90073
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Miami, Florida 33136
Principal Investigator: Shivank Bhatia, MD
Phone: 305-243-3404
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1400 NW 12th Ave
Miami, Florida 33136
(305) 689-5511
Principal Investigator: Shivank Bhatia, MD
Phone: 305-243-3404
University of Miami Hospital The University of Miami changed the face of modern health care...
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300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
Phone: 650-736-1252
Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 444-2000
Georgetown University Hospital MedStar Georgetown University Hospital is a not-for-profit, acute-care teaching and research hospital...
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