Optilume™ BPH Catheter System for Enlarged Prostate

(PINNACLE Trial)

Recruiting at 20 trial locations

Overseen By Ian Schorn

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Urotronic Inc.

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

162 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a special catheter designed to treat men with an enlarged prostate. The device helps to open up the urinary passage, making it easier to urinate. The goal is to see if this treatment is safe and effective for these patients.

Will I have to stop taking my current medications?

The trial requires stopping certain medications before participating. You may need to stop taking medications like antihistamines, anticonvulsants, antispasmodics, antidepressants with adrenergic effects, long-acting anticholinergics, and others within specific timeframes before the trial. It's best to discuss your current medications with the trial team to see if any changes are needed.

What data supports the effectiveness of the Optilume BPH Catheter System treatment for an enlarged prostate?

Research shows that the Optilume BPH Catheter System, which uses a balloon to open the prostate and delivers a drug called paclitaxel to keep it open, has positive outcomes for improving urinary symptoms and quality of life in men with an enlarged prostate. ^{1 2 3 4 5}

Is the Optilume BPH Catheter System safe for treating an enlarged prostate?

The Optilume BPH Catheter System has been evaluated in studies like the PINNACLE and EVEREST-I, which suggest it is generally safe for treating lower urinary tract symptoms due to an enlarged prostate, with favorable outcomes and minimal complications reported. ^{1 2 3 4 6}

How is the Optilume BPH Catheter System treatment different from other treatments for enlarged prostate?

The Optilume BPH Catheter System is unique because it combines balloon dilation with a localized delivery of paclitaxel (a drug that helps keep the passage open) to treat enlarged prostate symptoms. It can be done in an office setting without general anesthesia, offering a minimally invasive option with favorable outcomes for both function and sexual health. ^{1 2 3 4 5}

Research Team

Steven A Kaplan, MD

Principal Investigator

Mount Sinai Health System

Eligibility Criteria

Men aged 50-80 with symptomatic BPH, having a prostate size of 20 to 80 gm and specific urinary flow rates. They must have had an inadequate response or contraindication to BPH medical therapy. Exclusions include those with certain prostate conditions, recent use of specific drugs, history of hypersensitivity reactions to paclitaxel, confirmed malignancies, uncontrolled diabetes, and more.

Inclusion Criteria

International Prostate Symptom Score (IPSS) ≥ 13

My prostate size is between 20 to 80 grams as measured by ultrasound.

Able to complete the study protocol in the opinion of the investigator

Exclusion Criteria

I do not have any major health issues that could affect the study.

I have not used 5-alpha reductase inhibitors like Avodart in the last 6 months.

I have had blood in my urine twice in the last 3 months without a clear reason.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Optilume BPH Catheter System or Sham Device to treat LUTS/BPH

12 months

Pharmacokinetics

A single arm of 15 non-randomized subjects will be treated to study the pharmacokinetics of the drug

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

• Optilume BPH Catheter System
• Optilume Sham Device

Trial Overview The PINNACLE trial is testing the Optilume™ BPH Catheter System against a sham device in men with benign prostatic hyperplasia (BPH). It's designed to see if this system is safe and effective for treating symptoms associated with an enlarged prostate.

Participant Groups

Group I: Pharmacokinetics Optilume Arm Experimental Treatment 1 Intervention

A single arm of 15 non-randomized subjects will be treated in the pharmacokinetics (PK) arm. These subjects will be treated with the Optilume BPH Catheter System

Group II: Optilume™ BPH Catheter System Experimental Treatment 1 Intervention

The Optilume™ BPH, Prostatic Dilation DCB Catheter is a dilation catheter used to exert radial force to dilate the prostatic urethra resulting in a commissurotomy. The distal end of the catheter has a semi-compliant inflatable double lobe balloon that is coated with a proprietary coating containing the active pharmaceutical paclitaxel.

Group III: Sham Device Placebo Group 1 Intervention

The Sham Device is a 21 Fr Optilume BPH, Prostatic Pre-dilation Catheter within the sheath.

Who Is Running the Clinical Trial?

Urotronic Inc.

Lead Sponsor

Trials

10

Recruited

1,400+

ClinLogix. LLC

Industry Sponsor

Trials

11

Recruited

1,700+

Findings from Research

The Optilume BPH Catheter System significantly improved lower urinary tract symptoms in men with benign prostatic hyperplasia, showing a reduction in the International Prostate Symptom Score by 11.5 points at 1 year, compared to 8.0 points in the sham group.

Patients treated with Optilume BPH experienced a remarkable 125% increase in urinary flow rate, while the treatment was well tolerated and preserved sexual function, making it a promising minimally invasive option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The PINNACLE Study: A Double-blind, Randomized, Sham-controlled Study Evaluating the Optilume BPH Catheter System for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia. Kaplan, SA., Moss, J., Freedman, S., et al.[2023]

The Optilume BPH Catheter System significantly improved lower urinary tract symptoms (LUTS) in 80 subjects over 2 years, with IPSS scores dropping from 22.3 to 8.2, indicating effective symptom relief.

Functional improvements were also notable, with peak urinary flow rate (Qmax) increasing from 10.9 mL/s to 17.2 mL/s, and post-void residual urine volume (PVR) decreasing from 63.1 mL to 45.0 mL, while treatment-related adverse events were mostly minor and none occurred after the first year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Durable benefit after treatment of obstructive benign prostatic hyperplasia with a novel drug-device combination product: 2-year outcomes from the EVEREST-I study. Pichardo, M., Rijo, E., Espino, G., et al.[2023]

The Optilume BPH Catheter System is a minimally invasive treatment for benign prostatic hyperplasia (BPH) that combines balloon dilation with localized delivery of paclitaxel, which helps maintain long-term effectiveness.

This system can be used in an office setting without the need for general anesthesia, and early data suggest it leads to positive functional and sexual outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How I Do It: Optilume BPH catheter system. Elterman, DS., Gao, B., Zorn, KC., et al.[2023]

The Optilume® BPH Catheter System demonstrated significant efficacy in treating lower urinary tract symptoms (LUTS) related to benign prostatic hyperplasia (BPH), with 81% of subjects showing a ≥40% improvement in their International Prostate Symptom Score (IPSS) at both 3 months and 1 year after treatment.

The treatment was safe, with improvements in urinary flow rates and quality of life scores, and the results suggest that this minimally invasive approach could be a promising option for patients suffering from LUTS due to BPH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-year outcomes after treatment with a drug-coated balloon catheter system for lower urinary tract symptoms related to benign prostatic hyperplasia. Kaplan, SA., Pichardo, M., Rijo, E., et al.[2022]

The Urolume self-expanding flexible endourethral stent was found to be effective in improving symptoms and urinary flow rates in patients with bladder outlet obstruction due to benign prostatic hyperplasia (BPH), with significant improvements noted over a 5-year follow-up period.

Despite a high failure rate attributed to selection and deployment challenges, the Urolume stent was confirmed to be a safe device, with most patients experiencing sustained symptom relief and good quality of life after the first year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term clinical results and quality of life after insertion of a self-expanding flexible endourethral prosthesis. Anjum, MI., Chari, R., Shetty, A., et al.[2019]

A review of 2567 reports on various BPH treatment devices showed that over 99% of patients experienced no complications from device malfunctions, indicating a high level of safety across the modalities studied.

The use of morcellators during HoLEP was associated with the highest rate of serious complications, suggesting that urologists should be cautious and choose devices they are most familiar with to minimize risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Device Malfunctions and Complications Associated with Benign Prostatic Hyperplasia Surgery: Review of the Manufacturer and User Facility Device Experience Database. Patel, NH., Uppaluri, N., Iorga, M., et al.[2021]

References

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

The PINNACLE Study: A Double-blind, Randomized, Sham-controlled Study Evaluating the Optilume BPH Catheter System for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

Durable benefit after treatment of obstructive benign prostatic hyperplasia with a novel drug-device combination product: 2-year outcomes from the EVEREST-I study. [2023]

3. Canada pubmed.ncbi.nlm.nih.gov

How I Do It: Optilume BPH catheter system. [2023]

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

One-year outcomes after treatment with a drug-coated balloon catheter system for lower urinary tract symptoms related to benign prostatic hyperplasia. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Long-term clinical results and quality of life after insertion of a self-expanding flexible endourethral prosthesis. [2019]

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

Device Malfunctions and Complications Associated with Benign Prostatic Hyperplasia Surgery: Review of the Manufacturer and User Facility Device Experience Database. [2021]