Prostate Cancer Clinical Trial

Prostate Artery Embolization (PAE) for Treatment of Benign Prostatic Hyperplasia

Summary

The purpose of this project is to evaluate the safety, efficacy, and feasibility of performing prostatic artery embolization (PAE) using endovascular techniques and particle embolics in men suffering from lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).

View Full Description

Full Description

This pilot study is a prospective, non-randomized clinical trial assessing the safety and feasibility of prostatic artery embolization. Fifty adult male subjects will be enrolled and treated in this study. Patients who provide informed consent and are deemed eligible for participation will undergo prostatic artery embolization in the Interventional Radiology department at the University of Virginia. After performing an angiogram to identify the prostatic arteries, tiny particles known as Embozene Microspheres will be injected into the prostatic artery. Injecting these particles into the prostatic artery will slow blood flow to the prostate and thus shrinking the size of the prostate. By shrinking the size of the prostate, it is hopeful that it will provide relief of lower urinary tract symptoms due to BPH. Subjects will be followed for 2 years as part of their participation in this study.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Patients between ages 45-80 years
Diagnosis of Lower Urinary Tract Symptoms from Benign Prostatic Hypertrophy for a minimum of 6 months
IPSS score at initial evaluation should be greater than 7, and uroflowmetry (Qmax) of <12mL/s (milliliters per second) .
All prostate volumes will be at least 40gm and no more than 400gm based on DRE, TRUS, or cross sectional imaging

Exclusion Criteria:

Patients with urinary tract infections (> 2/year), prostatitis, or interstitial cystitis
Cases of biopsy proven prostate cancer or urethral cancer.
Patients on long-term narcotic analgesia, androgen therapy, or GNRH (gonadotropin-releasing hormone) analogue therapy within 2 months of study.
Patients who are classified as New York Heart Association Class III (Moderate), or higher.
Patients with history of prior pelvic irradiation.
Hypersensitivity reactions to contrast material not manageable with prophylaxis.
Patients with serum creatinine values >1.7mg/dl or glomerular filtration rates less than 50.

Study is for people with:

Prostate Cancer

Estimated Enrollment:

50

Study ID:

NCT02592473

Recruitment Status:

Unknown status

Sponsor:

University of Virginia

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

University of Virginia Health Systems
Charlottesville Virginia, 22908, United States More Info
Joshua Feazell, BS
Contact
434-297-5682
[email protected]
Brigitte J Kelly, BSN RN CCRC
Contact
434-297-7136
[email protected]
Ziv J Haskal, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Estimated Enrollment:

50

Study ID:

NCT02592473

Recruitment Status:

Unknown status

Sponsor:


University of Virginia

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider