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

• ClinicalTrials.gov Identifier: NCT04131907
• Recruitment Status: Active, not recruiting
• First Posted: October 18, 2019
• Last Update Posted: November 1, 2022
• Sponsor: Urotronic Inc.
• Collaborator: ClinLogix. LLC
• Information provided by (Responsible Party): Urotronic Inc.

Tracking Information

• First Submitted Date: October 16, 2019
• First Posted Date: October 18, 2019
• Last Update Posted Date: November 1, 2022
• Actual Study Start Date: February 5, 2020
• Actual Primary Completion Date: August 23, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 17, 2019)

• Change in International Prostate Symptom Score (IPSS) [ Time Frame: 12 months ]
  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.
• Major Device Related Serious Complications [ Time Frame: 12 months ]
  Rate of major device related serious complications

Original Primary Outcome Measures (submitted: October 16, 2019)

• Change in International Prostate Symptom Score (IPSS) [ Time Frame: 12 months ]
  Change in subjects' IPSS Score from pre-procedure to 12-months
• Major Device Related Serious Complications [ Time Frame: 12 months ]
  Rate of major device related serious complications

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Clinical Study to Evaluate the Safety and Efficacy of the Optilume™ BPH Catheter System in Men With Symptomatic BPH
• Official Title: 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
• Brief Summary: 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)
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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 (Participant, Outcomes Assessor)
Masking Description:

Subjects in the Randomization arm of the study are randomized in a 2:1 allocation of Test to Control. The treating physician is unblinded to the treatment assignment. A blinded person at the study site conducts all study follow-up visits through the 12-Month follow-up visit (or until the subject is unblinded). The subject may be unblinded prior to the 12-Month visit if it is medically necessary, which includes the subject seeking alternative BPH therapy due to continued or recurrent BPH symptoms.

Primary Purpose: Treatment

• Condition: Benign Prostatic Hyperplasia

Intervention

• Device: Optilume BPH Catheter System
  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 Sham Device
  21 Fr sheathed Optilume™ BPH Prostatic Pre-dilation Catheter (modified to prevent inflation)

Study Arms

• Experimental: Optilume™ BPH Catheter System
  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.
  Intervention: Device: Optilume BPH Catheter System
• Sham Comparator: Sham Device
  The Sham Device is a 21 Fr Optilume BPH, Prostatic Pre-dilation Catheter within the sheath.
  Intervention: Device: Optilume Sham Device
• Experimental: Pharmacokinetics Optilume Arm
  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
  Intervention: Device: Optilume BPH Catheter System

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: September 15, 2020): 500
• Original Estimated Enrollment (submitted: October 16, 2019): 162
• Estimated Study Completion Date: May 2027
• Actual Primary Completion Date: August 23, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Male subject 50-80 years of age who has symptomatic BPH
2. International Prostate Symptom Score (IPSS) ≥ 13
3. Peak urinary flow rate (Qmax) ≥ 5 ml/sec and ≤ 12 ml/sec (with minimum voided volume of ≥ 150 ml)
4. Prostate volume 20 to 80 gm as determined by transrectal ultrasound (TRUS)
5. Prostatic urethral length ≥ 32 mm and ≤ 55 mm as determined by TRUS
6. History of inadequate response, contraindication, or refusal of BPH medical therapy
7. Able to complete the study protocol in the opinion of the investigator

Exclusion Criteria:

1. Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with all the follow-up requirements
2. Unwilling to abstain or use protected sex for the first 30 days post treatment
3. Unwilling to abstain from sexual intercourse or use a highly effective contraceptive for at least 6 months post-procedure
4. Presence of an artificial urinary sphincter or stent(s) in the urethra or prostate
5. Any prior minimally invasive intervention (e.g. TUNA, Balloon, Microwave, Rezūm, UroLift) or surgical intervention of the prostate
6. Prostate specific antigen (PSA) ≥ 10 ng/ml unless prostate cancer is ruled out by biopsy
7. Confirmed or suspected malignancy of prostate or bladder
8. Active or history of epididymitis within the past 3 months
9. Previous pelvic irradiation or pelvic trauma surgery
10. Active urinary tract infection (UTI) confirmed by culture
11. Bacterial prostatitis within the last 12 months
12. Non-bacterial prostatitis within the last 5 years
13. 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
14. Neurogenic bladder or sphincter abnormalities or neurological disorders that might affect bladder or sphincter function
15. History of urinary incontinence
16. Previous or current diagnosis of urethral strictures, bladder neck contracture or detrusor muscle spasms
17. Previous rectal surgery, other than hemorrhoidectomy
18. 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
19. 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
20. Use of Luteinizing Hormone-Releasing Hormone (LHRH) analogs within 12 months prior to baseline assessment
21. Use of Type II 5-alpha reductase inhibitor [e.g. finasteride (Proscar, Propecia)] within 3 months of baseline assessment
22. Use of 5-alpha reductase inhibitor [e.g. dutasteride (Avodart)] within 6 months of baseline assessment
23. 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
24. Use of alpha blockers or daily dose PDE5 inhibitor (e.g. Cialis) within 2 weeks of baseline assessment
25. 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
26. Use of anti-platelet medications (e.g., clopidogrel, aspirin) within 10 days prior to the procedure or planned use within 5 days post-procedure
27. 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
28. Incidence of spontaneous urinary retention within 6 months prior to baseline assessment
29. Current post-void residual volume > 300 ml or catheter dependent bladder drainage
30. Known poor detrusor muscle function (e.g. Qmax < 5 ml/sec)
31. Current bladder or prostatic urethral stones
32. Biopsy of prostate within 40 days prior to procedure
33. 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
34. Current uncontrolled diabetes (i.e. hemoglobin A1c ≥ 8%)
35. 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
36. 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
37. Life expectancy < 10 years
38. Anatomy (e.g. presence of false passage or size of meatus) is not suitable for treatment in this study
39. Significant median lobe component [e.g. intravesical prostatic protrusion (IPP) > 1 cm]
40. Device that corresponds with the subject's prostate size is not available
41. Currently enrolled in or plan to enroll in another investigational clinical study for any disease except for observational only study
42. In the opinion of the investigator, it is not in the subject's best interest to participate in the study

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 50 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, United States

Administrative Information

• NCT Number: NCT04131907
• Other Study ID Numbers: PR1087
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Urotronic Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Urotronic Inc.
• Original Study Sponsor: Same as current
• Collaborators: ClinLogix. LLC

Investigators

• Principal Investigator: Steven A Kaplan, MD; Mount Sinai Health System

• PRS Account: Urotronic Inc.
• Verification Date: October 2022