Investigation of Prostate Artery Embolization Compared to Holmium Laser Enucleation of Prostate

NCT ID: NCT05155891

Last Updated: 2025-05-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-17
• Study Completion Date: 2027-01-01

Brief Summary

The purpose of this research study is to evaluate prostate artery embolization (PAE) compared to Holmium laser enucleation of prostate (HoLEP) in improving a patient's overall prostate related symptoms.

Conditions

Benign Prostatic Hyperplasia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Embosphere Microspheres group

Participants in this group who are undergoing standard of care (SOC) prostate artery embolization (PAE) for treatment of their symptomatic benign prostatic hyperplasia (BPH) will receive Embosphere Microspheres during scheduled SOC PAE surgery.

Group Type: EXPERIMENTAL

Embosphere Microspheres

Intervention Type: DEVICE

The SOC PAE procedure will be performed by attempting to embolize prostatic arteries of both sides in a single session with 300-500 um Embosphere Microspheres. The microspheres will be mixed with a contrast agent and will be delivered to the arteries supplying the prostate via a microcatheter.

HoLEP Group

Participants in this group who are undergoing SOC PAE for treatment of their symptomatic benign prostatic hyperplasia (BPH) will receive SOC Holmium laser enucleation of prostate (HoLEP).

Group Type: ACTIVE_COMPARATOR

HoLEP Procedure

Intervention Type: PROCEDURE

The SOC PAE procedure will be performed with the SOC HoLEP as per standard institutional guidelines. The HoLEP procedure involves passing a telescope through the urethra and removing the central part of the prostate gland using a laser.

Interventions

Embosphere Microspheres

The SOC PAE procedure will be performed by attempting to embolize prostatic arteries of both sides in a single session with 300-500 um Embosphere Microspheres. The microspheres will be mixed with a contrast agent and will be delivered to the arteries supplying the prostate via a microcatheter.

Intervention Type: DEVICE

HoLEP Procedure

The SOC PAE procedure will be performed with the SOC HoLEP as per standard institutional guidelines. The HoLEP procedure involves passing a telescope through the urethra and removing the central part of the prostate gland using a laser.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Patient is age 50 or older.

2. Patient has signed informed consent and agrees to attend all follow-up study visits.

3. Patient has had LUTS secondary to BPH or any complications secondary to BPH and qualifying for active intervention.

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

5. Patient has a prostate size of at least 80 grams and not more than 250 grams, measured by magnetic resonance imaging (MRI) or transrectal ultrasonography (TRUS).

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 HoLEP or PAE.

Exclusion Criteria

1. Subject has untreated active infection (e.g., active urinary tract infection or prostatitis)

2. Subject has a diagnosis or received treatment for chronic prostatitis or chronic pelvic pain syndrome (e.g., nonbacterial chronic prostatitis).

3. Patients with indwelling urinary catheters or those performing self-catheterization.

4. Biopsy proven prostate or bladder cancer.

• Patient with elevated PSA will be counselled by urologist and a shared decision will be made with the patient after discussion about pros and cons of prostate biopsy.

5. Patients with neurogenic bladder disorder.

6. 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.

7. Patients with prior history transurethral resection of the prostate (TURP), Green Light laser treatment, or other prostate surgical treatments within past year(12 months).

8. 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.

9. 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.

10. Acute myocardial infarction, open heart surgery, or cardiac arrest within 180 days prior to the date of informed consent.

11. Patient is interested in future fertility and wish to preserve ejaculation will be excluded from HoLEP arm

12. History of coagulation cascade disorders (which are not normalized by medical treatment before the procedure) or disorders that affect platelet count or function (e.g., von Willebrand disease) that would put the subject at risk for intraoperative or postoperative bleeding.

13. History of major allergic reaction to iodinated contrast agents will be excluded from PAE arm.

14. History of hypersensitivity to gelatin products will be excluded from PAE arm.

15. Subject has a life expectancy of less than 2 yrs.

16. Post void residual more than 500 ml at baseline.

17. Participation in any other BPH trials during the time of study.

• Minimum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Hemendra Shah

Professor of Clinical Urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hemendra Shah, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Countries

United States

Other Identifiers

20210029

Identifier Type: -

Identifier Source: org_study_id