Overview
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.
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.
Eligibility
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