RT-310 Dose Escalation BPH Study

Study Overview
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Brief Summary
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RT-310, a novel implant, is intended to minimally invasive treat locally the prostate gland for the management of prostate disease, while minimizing side-effects. The objectives of the study are to assess whether RT-310 is safe and feasible for the participant population.

Detailed Description
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The RT-310 study is a first in human Phase 1 multi-center prospective, non-randomized dose escalation study to evaluate the safety and feasibility of RT-310 for treatment of Benign Prostatic Hyperplasia (BPH). Study participants will have placement of RT-310 and be followed through 180 days.

Official Title
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Safety and Feasibility Dose Escalation Study for Evaluation of RT-310 for Treatment of Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostatic Hyperplasia (BPH)

Conditions
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BPH (Benign Prostatic Hyperplasia), Lower Urinary Tract Symptoms

Intervention / Treatment
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* Combination Product: RT-310


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Male gender Diagnosis of symptomatic BPH Age ≥ 50 years up to 80 years International Prostate Symptom Score (IPSS) ≥ 13 Prostate volume 30 to 80 cc per ultrasound Inadequate response and/or refusal of medical therapy for LUTS Key Exclusion Criteria: Current urinary retention or at significant risk of urinary retention after drug washout Have an obstructive or protruding median lobe of the prostate Previous BPH surgical procedure or implants, urethral stricture, Any prior minimally invasive intervention (e.g. TUNA, Balloon, Microwave, Rezūm, UroLift) or surgical intervention of the prostate Previous pelvic surgery or irradiation History of neurogenic or atonic bladder Stress urinary incontinence, mixed or urge incontinence History of prostate or bladder cancer, confirmed or suspected malignancy of prostate or bladder History of compromised renal function or upper urinary tract disease Other co-morbidities that could impact the study results such as: severe cardiac arrhythmias uncontrolled by medications or pacemaker; congestive heart failure New York Heart Association (NYHA) III or IV; History of uncontrolled diabetes mellitus; significant respiratory disease in which hospitalization may be required Known immunosuppression (i.e. AIDS, post-transplant, undergoing chemotherapy) No more than two documented active urinary tract infections (UTI) by culture or bacterial prostatitis within last year documented by culture (UTI is defined as >100,000 colonies per ml urine from midstream clean catch or catheterization specimen) Current gross hematuria and/or visible hematuria with participant urine sample without known contributing factor Presence of a penile implant or stent(s) in the urethra or prostate PSA > 10 ng/ml unless prostate cancer is ruled out by biopsy. If PSA is > 4 ng/ml and ≤ 10 ng/ml, prostate cancer must be ruled out to the satisfaction of the investigator via additional tests including digital rectal exam (DRE) and/or biopsy Sensitivity to RT-310 Unable to undergo magnetic resonance imaging (MRI) such as presence of cardiac pacemaker or implanted cardiac defibrillator Parkinson's disease or other neurologic disease that may impact bladder function such as stroke, TIA, multiple sclerosis

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: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RT-310 Cohort 1<br>Combination Product: RT-310 implant Cohort 1 | Combination Product: RT-310<br>* Combination Product: RT-310 Implant for Investigational Treatment of Lower Urinary Tract Symptoms Secondary to BPH (Benign Prostatic Hyperplasia)<br>|
| Experimental: RT-310 Cohort 2<br>Combination Product: RT-310 Implant Cohort 2 | Combination Product: RT-310<br>* Combination Product: RT-310 Implant for Investigational Treatment of Lower Urinary Tract Symptoms Secondary to BPH (Benign Prostatic Hyperplasia)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of unanticipated adverse events (UAEs) not listed in the protocol or Adverse Events (AEs) that meet the protocol definition of Serious Adverse Events (SAEs) | Adverse events | Baseline to Day 180 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in prostate volume | Transrectal ultrasound | Baseline to Day 180 | 
| Change in IPSS | International Prostate Symptom Score (IPSS); IPSS scores range from 0 (no symptoms) to 35 (severe symptoms) | Baseline to Day 180 | 
| Uroflowmetry measure of Qmax | Uroflowmetry measure of peak flow rate Qmax (mL/s) | Baseline to Day 180 | 
| Uroflowmetry measure of Qave | Uroflowmetry measure of average flow rate, Qave (mL/s) | Baseline to Day 180 | 
| Uroflowmetry measure of voided volume | Uroflowmetry measure of voided volume (mL) | Baseline to Day 180 | 
| PVR | Post void residual (PVR) measurement | Baseline to Day 180 |