Embolization vs HoLEP Procedure for Enlarged Prostate

Overseen By Shivank Bhataia, MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Prostate cancer, Neurogenic bladder, Cardiac condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 48 hours for hospitalization and urinary catheterization

45 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is evaluating two methods for addressing prostate issues to determine which one better improves symptoms in patients.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of this treatment for an enlarged prostate?

Research shows that using embosphere microspheres for prostatic artery embolization (PAE) is effective in treating symptoms of an enlarged prostate, with good safety and fewer side effects compared to other methods. Additionally, the HoLEP procedure is a standard treatment for benign prostatic hyperplasia (BPH) and is effective in reducing symptoms, although it may cause some postoperative complications. ^{1 2 3 4 5}

Is embolization using Embosphere Microspheres or tris-acryl gelatin microspheres safe for humans?

Research shows that embolization using Embosphere Microspheres and tris-acryl gelatin microspheres is generally safe for treating conditions like benign prostatic hyperplasia, with light adverse reactions and no major complications reported in studies. ^{1 3 4 6 7}

How does the Embosphere Microspheres treatment for enlarged prostate differ from other treatments?

The Embosphere Microspheres treatment is unique because it involves prostatic artery embolization (PAE), a minimally invasive procedure that reduces blood flow to the prostate, leading to its shrinkage and relief of symptoms. This approach is different from traditional surgical methods, as it uses tiny spheres to block blood vessels, offering a less invasive option with fewer complications. ^{1 3 4 5 6}

Research Team

Hemendra Shah, MD

Principal Investigator

University of Miami

Eligibility Criteria

Men over 50 with enlarged prostates (80-250 grams) and moderate to severe symptoms not improved by medication can join this study. They must have an IPSS Score >13, indicating significant urinary issues, and be eligible for PAE or HoLEP procedures. Those who've had certain prostate treatments in the last year, have serious bleeding disorders, allergies to specific medical substances, untreated infections, cancer diagnoses, or other major health conditions cannot participate.

Inclusion Criteria

I am eligible for prostate surgery or artery embolization.

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

My prostate is between 80 and 250 grams as measured by MRI or ultrasound.

Exclusion Criteria

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

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

I have a neurogenic bladder disorder.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either prostate artery embolization (PAE) or Holmium laser enucleation of prostate (HoLEP) for treatment of symptomatic benign prostatic hyperplasia

Up to 48 hours for hospitalization and urinary catheterization

Follow-up

Participants are monitored for changes in BPH symptoms, erectile function, retrograde ejaculation, PSA levels, and other outcomes

12 months

Treatment Details

Interventions

• Embosphere Microspheres
• HoLEP Procedure

Trial Overview The trial is comparing two different procedures for treating an enlarged prostate: Prostate Artery Embolization (PAE), which blocks blood flow to reduce size; and Holmium Laser Enucleation of Prostate (HoLEP), a laser treatment that removes excess tissue. The goal is to see which method better improves symptoms.

Participant Groups

Group I: Embosphere Microspheres group Experimental Treatment 1 Intervention

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 II: HoLEP Group Active Control 1 Intervention

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).

Embosphere Microspheres is already approved in United States, European Union for the following indications:

Approved in United States as Embosphere Microspheres for:

• Uterine fibroid embolization

Approved in European Union as Embosphere Microspheres for:

• Uterine fibroid embolization

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Findings from Research

In a study of 422 patients with prostatic hyperplasia, treatment with embosphere microspheres showed better safety and efficacy compared to gelatin sponge particles, with fewer adverse reactions and a lower chance of recurrent bleeding.

The use of embosphere microspheres resulted in less damage to prostatic function post-treatment, making it a favorable option for managing complications from prostatic hyperplasia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Study on the Treatment of Benign Prostatic Hyperplasia by Embolization of Prostate Artery Based on Embosphere Microspheres and Gelatin Sponge Granules. Liu, J., Shi, D., Li, L., et al.[2022]

In a Phase I study involving 30 patients, the use of tris-acryl gelatin microspheres for uterine artery embolization was technically successful in all cases, leading to significant improvements in menstrual bleeding and pelvic pain within three months.

The treatment was found to be safe, with only minor complications reported in nine patients and no major complications, indicating that this method could be a viable option for managing symptomatic leiomyomata.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial experience with use of tris-acryl gelatin microspheres for uterine artery embolization for leiomyomata. Spies, JB., Benenati, JF., Worthington-Kirsch, RL., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Comparative Study Using 100-300 Versus 300-500 μm Microspheres for Symptomatic Patients Due to Enlarged-BPH Prostates. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Holmium Laser Enucleation of the Prostate: Modified Two-Lobe Technique versus Traditional Three-Lobe Technique-A Randomized Study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Prostatic Artery Embolization for Benign Prostatic Hyperplasia: Prospective Randomized Trial of 100-300 μm versus 300-500 μm versus 100- to 300-μm + 300- to 500-μm Embospheres. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Clinical Study on the Treatment of Benign Prostatic Hyperplasia by Embolization of Prostate Artery Based on Embosphere Microspheres and Gelatin Sponge Granules. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Prostatic Artery Embolization Using 100-300-μm Trisacryl Gelatin Microspheres to Treat Lower Urinary Tract Symptoms Attributable to Benign Prostatic Hyperplasia: A Single-Center Outcomes Analysis with Medium-Term Follow-up. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Prostatic Artery Embolization Using Embosphere Microspheres for Prostates Measuring 80-150 cm(3): Early Results from a US Trial. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Initial experience with use of tris-acryl gelatin microspheres for uterine artery embolization for leiomyomata. [2019]