RT-310 Dose Escalation BPH Study

Launched by RESURGE THERAPEUTICS INC. · Nov 13, 2023

Keywords

ClinConnect Summary

The RT-310 Dose Escalation BPH Study is a clinical trial exploring a new treatment called RT-310, which is designed to help men with benign prostatic hyperplasia (BPH), a condition that can cause uncomfortable urinary symptoms. The goal of this study is to determine if RT-310 is safe and effective for treating this condition with minimal side effects. The trial is currently looking for men aged 50 to 80 who have been diagnosed with symptomatic BPH and have not had enough relief from other medications.

To participate, men must have a certain level of urinary symptoms and a prostate size within specific limits. However, there are some important health conditions that would exclude someone from joining, such as having a history of prostate or bladder cancer, certain urinary issues, or other significant health problems. If eligible, participants can expect to receive the RT-310 treatment and will be closely monitored throughout the study to ensure their safety. This research could lead to new options for managing BPH and improving quality of life for many men.

Gender

MALE

Eligibility 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