Optilume™ BPH Catheter System for Enlarged Prostate

(PINNACLE Trial)

Not currently recruiting at 20 trial locations

Overseen By Ian Schorn

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Urotronic Inc.

Must not be taking: Antidepressants, Anticholinergics, Androgens, Anticoagulants

Disqualifiers: Prostate cancer, UTI, Diabetes, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of the Optilume™ BPH Catheter System for men with an enlarged prostate (BPH). The study aims to determine if this new treatment can safely and effectively relieve symptoms such as frequent urination or difficulty starting urination. Participants are divided into different groups: some will receive the actual treatment, while others may undergo a sham (inactive) procedure for comparison. Men who have struggled with other BPH treatments and experience significant urination issues might be well-suited for this trial. As an unphased trial, this study offers a unique opportunity for patients to contribute to innovative research that could lead to new treatment options.

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 prior data suggests that the Optilume™ BPH Catheter System is safe for treating benign prostatic hyperplasia?

Research has shown that the Optilume™ BPH Catheter System is generally safe for treating an enlarged prostate. The possible side effects resemble those seen in standard procedures using a scope to examine the bladder (cystoscopy).

In studies, patients reported improved symptoms and quality of life over two years, suggesting that the treatment is well-tolerated. While some side effects occurred, they were expected for this type of procedure.

Overall, the Optilume BPH Catheter System appears to be a safe option for many patients with benign prostatic hyperplasia (BPH). ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike traditional treatments for enlarged prostate, which often involve medication or surgery, the Optilume™ BPH Catheter System offers a unique approach by using a dilation catheter with a special balloon coating. This system combines mechanical dilation with the delivery of paclitaxel, a drug that helps prevent tissue regrowth, directly to the prostate. Researchers are excited about this treatment because it potentially reduces tissue regrowth more effectively while minimizing side effects compared to standard procedures like TURP (transurethral resection of the prostate). The innovative use of a drug-coated balloon sets it apart, providing a less invasive option that could lead to quicker recovery and better outcomes for patients.

What evidence suggests that the Optilume BPH Catheter System is effective for treating benign prostatic hyperplasia?

Research has shown that the Optilume BPH Catheter System, which participants in this trial may receive, can effectively ease symptoms of an enlarged prostate, known as benign prostatic hyperplasia (BPH). In one study, patients experienced significant improvement in their symptoms and overall function after using this treatment. Another study found that the relief from symptoms lasted up to four years. The Optilume system widens the narrow part of the urethra using a balloon and is coated with paclitaxel, a medication that helps keep the passage open. These findings suggest that the Optilume BPH Catheter System could be a promising option for those experiencing BPH symptoms. Participants in this trial may also receive a sham device as part of the study's comparator arm. ^{2 3 5 6 7}

Who Is on the Research Team?

Steven A Kaplan, MD

Principal Investigator

Mount Sinai Health System

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

Citations

1. nature.com nature.com/articles/s41391-024-00833-z

Two-year long-term follow-up of treatment with the ... - Nature In the PINNACLE study, participants treated with the Optilume BPH Catheter System demonstrated strong improvement in symptoms and function ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11534392/

Long-term outcomes after treatment with Optilume BPH Long-term followup through four years for subjects treated with the Optilume BPH Catheter System indicates durable outcomes in symptom improvement and ...

3. auajournals.org auajournals.org/doi/10.1097/JU.0000000000003568

The PINNACLE Study - Journal of Urology This study compares the safety and efficacy of Optilume BPH to a sham surgical procedure for the treatment of LUTS secondary to BPH with outcomes reported ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11228686/

The Optilume BPH Catheter System for the treatment of ... Although the Optilume BPH treatment was significantly beneficial, the results may not be hypothesized toward all men experiencing LUTS ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06769997

Evaluation of the Optilume BPH Catheter System and ... The purpose of the present study is to compare between patient experience, symptom relief and functional improvement when using the Optilume BPH Catheter ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/P220029B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) Potential adverse effects after treatment with the Optilume BPH Catheter System are similar to standard cystoscopic procedures and mechanical ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06312722

Safety and Effectiveness of the Optilume® BPH Catheter ... The goal of this clinical trial is to verify the continued safety and effectiveness for the Optilume BPH Catheter System. STUDY ENDPOINTS.