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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two procedures for easing symptoms of an enlarged prostate. One group will receive prostate artery embolization (PAE) using tiny beads called Embosphere Microspheres to block blood flow to part of the prostate. The other group will undergo Holmium laser enucleation of the prostate (HoLEP), which uses a laser to remove prostate tissue. Men with long-term urinary problems due to an enlarged prostate, whose symptoms haven't improved with medication, might be suitable for this study. As an unphased trial, this study offers patients the chance to explore alternative treatments for symptom relief.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that Embosphere Microspheres are generally well-tolerated for treating an enlarged prostate. Research indicates they can effectively reduce blood flow to the prostate and improve symptoms without causing major side effects. One study found that patients using these microspheres experienced significant improvements in their symptoms and safety outcomes.

Regarding the HoLEP procedure, research suggests it is a safe and effective way to treat an enlarged prostate. It has been proven to improve symptoms with low complication rates. However, one study noted that HoLEP might have a higher rate of side effects compared to other treatments, though these are usually not severe.

Both treatments have been used for a while and show good safety profiles overall. For those considering joining a trial, these findings suggest that both options are generally safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the treatments Embosphere Microspheres and HoLEP for enlarged prostate because they offer distinct approaches compared to traditional methods. Embosphere Microspheres are used in prostate artery embolization (PAE) and work by blocking blood flow to the prostate, potentially reducing its size and symptoms without invasive surgery. This approach shifts away from the physical removal of prostate tissue. On the other hand, the HoLEP procedure uses a Holmium laser to precisely remove excess prostate tissue, providing an alternative to more invasive surgical procedures. Both treatments aim to improve patient outcomes with fewer side effects and quicker recovery times than conventional options.

What evidence suggests that this trial's treatments could be effective for enlarged prostate?

In this trial, participants will join one of two treatment groups. Participants in one group will receive Embosphere Microspheres, which studies have shown significantly improve symptoms related to an enlarged prostate, such as urinary problems. Research indicates that these microspheres reduce symptoms for a long time, regardless of age or prostate size. Meanwhile, participants in the other group will undergo the HoLEP procedure, which has also proven effective. It often provides better symptom relief compared to some other treatments, although it might have more side effects. Both treatments in this trial effectively address symptoms of prostate enlargement. ^{2 3 6 7 8}

Who Is on the Research Team?

Hemendra Shah, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1155/2022/1424021

Clinical Study on the Treatment of Benign Prostatic ... We aim to compare and analyze the safety and clinical effect of embolization of the target blood vessels of ruptured prostatic hyperplasia with gelatin sponge ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31029381/

Prospective Randomized Trial of 100-300 μm versus ... PAE outcomes were not significantly different among microspheres of different sizes. The use of 100- to 300-μm microspheres was associated with an increased ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S105104431930692X

Prostatic Artery Embolization Using 100–300-μm Trisacryl ... PAE with 100–300-μm microspheres produced sustained substantial improvements in LUTS, PGV, and PVR, which were independent of baseline PGV, MLE, age, or CCI.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02679430

Analysis of Prostatic Arterial Embolization for Benign ... The purpose of this study is to demonstrate the safety and efficacy of the device, Embosphere Microspheres, in prostatic arterial embolization (PAE). PAE, is ...

5. evtoday.com evtoday.com/articles/2020-apr/prostatic-artery-embolization-for-benign-prostatic-hyperplasia-a-10-year-update

Prostatic Artery Embolization for Benign ... Some studies have shown that using < 300-µm microspheres could be safe and effective for PAE11,15,35,43 and that PAE with smaller (< 300 µm) microspheres could ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8808190/

Clinical Study on the Treatment of Benign Prostatic ... The embosphere microsphere particles have good efficacy and safety in the treatment of prostatic hyperplasia rupture and bleeding compared with the commonly ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/DEN160040.pdf

De Novo Summary - DEN160040 Page 1 of 22 Embosphere Microspheres are indicated for use in embolization of arteriovenous malformations, hypervascular tumors, including symptomatic uterine fibroids, and ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9458568/

Prostatic Artery Embolization (PAE) Using Polyethylene ... PAE with PEGM is safe and effective treatment in patients with symptomatic BPH, with a significant improvement in both subjective and objective outcomes.