BPH (Benign Prostatic Hyperplasia), Lower Urinary Tract Symptoms
Conditions
Brief summary
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
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.
Interventions
COMBINATION_PRODUCTRT-310
Combination Product: RT-310 Implant for Investigational Treatment of Lower Urinary Tract Symptoms Secondary to BPH (Benign Prostatic Hyperplasia)
Sponsors
Resurge Therapeutics Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Baseline to Day 180 | Adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in IPSS | Baseline to Day 180 | International Prostate Symptom Score (IPSS); IPSS scores range from 0 (no symptoms) to 35 (severe symptoms) |
| Uroflowmetry measure of Qmax | Baseline to Day 180 | Uroflowmetry measure of peak flow rate Qmax (mL/s) |
| Change in prostate volume | Baseline to Day 180 | Transrectal ultrasound |
| Uroflowmetry measure of voided volume | Baseline to Day 180 | Uroflowmetry measure of voided volume (mL) |
| PVR | Baseline to Day 180 | Post void residual (PVR) measurement |
| Uroflowmetry measure of Qave | Baseline to Day 180 | Uroflowmetry measure of average flow rate, Qave (mL/s) |
Countries
Australia, New Zealand
Outcome results
None listed