A Clinical Study to Evaluate the Safety and Efficacy of the Optilume™ BPH Catheter System in Men With Symptomatic BPH

Study Overview
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Brief Summary
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PINNACLE is a prospective, multi-center, randomized control clinical trial to establish the safety and efficacy of the Optilume™ BPH Catheter System in the treatment of benign prostatic hyperplasia (BPH)

Official Title
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A Prospective, Multicenter, Double Blind, Randomized, Clinical Study to Evaluate the Safety and Efficacy of the Optilume™ BPH Catheter System in Men With Symptomatic BPH

Conditions
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Benign Prostatic Hyperplasia

Intervention / Treatment
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* Device: Optilume BPH Catheter System
* Device: Optilume Sham Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male subject 50-80 years of age who has symptomatic BPH International Prostate Symptom Score (IPSS) ≥ 13 Peak urinary flow rate (Qmax) ≥ 5 ml/sec and ≤ 12 ml/sec (with minimum voided volume of ≥ 150 ml) Prostate volume 20 to 80 gm as determined by transrectal ultrasound (TRUS) Prostatic urethral length ≥ 32 mm and ≤ 55 mm as determined by TRUS History of inadequate response, contraindication, or refusal of BPH medical therapy Able to complete the study protocol in the opinion of the investigator Exclusion Criteria: Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with all the follow-up requirements Unwilling to abstain or use protected sex for the first 30 days post treatment Unwilling to abstain from sexual intercourse or use a highly effective contraceptive for at least 6 months post-procedure Presence of an artificial urinary sphincter or stent(s) in the urethra or prostate Any prior minimally invasive intervention (e.g. TUNA, Balloon, Microwave, Rezūm, UroLift) or surgical intervention of the prostate Prostate specific antigen (PSA) ≥ 10 ng/ml unless prostate cancer is ruled out by biopsy Confirmed or suspected malignancy of prostate or bladder Active or history of epididymitis within the past 3 months Previous pelvic irradiation or pelvic trauma surgery Active urinary tract infection (UTI) confirmed by culture Bacterial prostatitis within the last 12 months Non-bacterial prostatitis within the last 5 years Visible or invisible hematuria (> 4 Red Blood Cells (RBCs) per high power field) on 2 separate urine specimens within the last 3 months without a know contributing factor Neurogenic bladder or sphincter abnormalities or neurological disorders that might affect bladder or sphincter function History of urinary incontinence Previous or current diagnosis of urethral strictures, bladder neck contracture or detrusor muscle spasms Previous rectal surgery, other than hemorrhoidectomy Use of antihistamines, anticonvulsants or antispasmodics within 1 week prior to baseline assessment unless there is documented evidence of stable dosing for at least 6 months Use of antidepressants with adrenergic effects (i.e. duloxetine, imipramine and amitriptyline), long-acting anticholinergics (LAAC) for chronic obstructive pulmonary disease (COPD), or androgens within 2 weeks prior to baseline assessment unless there is documented evidence of stable dosing for at least 3 months prior to baseline assessment Use of Luteinizing Hormone-Releasing Hormone (LHRH) analogs within 12 months prior to baseline assessment Use of Type II 5-alpha reductase inhibitor [e.g. finasteride (Proscar, Propecia)] within 3 months of baseline assessment Use of 5-alpha reductase inhibitor [e.g. dutasteride (Avodart)] within 6 months of baseline assessment Use of estrogen or drugs producing androgen suppression unless there is documented evidence of stable dosing for at least 3 months prior to baseline assessment Use of alpha blockers or daily dose PDE5 inhibitor (e.g. Cialis) within 2 weeks of baseline assessment Use of warfarin or novel oral anti-coagulants [e.g., apixaban (Eliquis), fondaparinux (Arixtra), rivaroxaban (Xarelto) or edoxaban (Savaysa)], unless the medication is safely discontinued prior to the procedure and is not planned to be restarted for at least 5 days post-procedure Use of anti-platelet medications (e.g., clopidogrel, aspirin) within 10 days prior to the procedure or planned use within 5 days post-procedure History of hypersensitivity reactions to paclitaxel, on medication that may have negative interaction with paclitaxel, presence of solid tumor with a baseline neutrophil count of <1500 cells/mm3 or AIDS-related Kaposi's sarcoma with baseline neutrophil count of <1000 cells/mm3 Incidence of spontaneous urinary retention within 6 months prior to baseline assessment Current post-void residual volume > 300 ml or catheter dependent bladder drainage Known poor detrusor muscle function (e.g. Qmax < 5 ml/sec) Current bladder or prostatic urethral stones Biopsy of prostate within 40 days prior to procedure History of cancer in non-genitourinary system which is not considered in complete remission (except basal cell or squamous cell carcinoma of the skin). A potential participant is considered in complete remission if there has been no evidence of cancer within five years Current uncontrolled diabetes (i.e. hemoglobin A1c ≥ 8%) History of clinically significant comorbidities or presence of unstable conditions [e.g. cardiovascular, lung, renal (serum creatinine > 2.0 mg/dl), hepatic, bleeding disorders or metabolic impairment] that may confound the results of the study or have a risk to subject per investigator's opinion Any cognitive disorder that interferes with or precludes direct and accurate communication with the study investigator regarding the study or affects the ability to complete the study quality of life questionnaires Life expectancy < 10 years Anatomy (e.g. presence of false passage or size of meatus) is not suitable for treatment in this study Significant median lobe component [e.g. intravesical prostatic protrusion (IPP) > 1 cm] Device that corresponds with the subject's prostate size is not available Currently enrolled in or plan to enroll in another investigational clinical study for any disease except for observational only study In the opinion of the investigator, it is not in the subject's best interest to participate in the study

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized study with a non-randomized, Pharmacokinetics arm. Subjects randomized to the Control arm are allowed to crossover to the Test arm if they meet the eligibility criteria after completing the 3-Month Follow-up Visit and prior to the close of the 12-Month visit window. Up to 625 subjects will be enrolled (i.e. consented) in the study in order to identify 162 eligible subjects (147 randomized subjects and 15 Pharmacokinetic subjects)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Optilume™ BPH Catheter System<br>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. | Device: Optilume BPH Catheter System<br>* 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.<br>|
| Sham Comparator: Sham Device<br>The Sham Device is a 21 Fr Optilume BPH, Prostatic Pre-dilation Catheter within the sheath. | Device: Optilume Sham Device<br>* 21 Fr sheathed Optilume™ BPH Prostatic Pre-dilation Catheter (modified to prevent inflation)<br>|
| Experimental: Pharmacokinetics Optilume Arm<br>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 | Device: Optilume BPH Catheter System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in International Prostate Symptom Score (IPSS) | Change in subjects' International Prostate Symptom Score (IPSS) from pre-procedure to 12-months. The IPSS can be interpreted as follows: 0-7 mildly symptomatic, 8-19 moderately symptomatic, and 20-35 severely symptomatic. | 12 months | 
| Major Device Related Serious Complications | Rate of major device related serious complications | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BPH, Drug Coated Balloon, DCB, prostate, LUTS, Optilume