Minimally invasive treatment for enlarged prostate
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)
PHASE1 · Resurge Therapeutics Inc. · NCT06136819
This study is testing a new implant to see if it can safely help men aged 50 to 80 with enlarged prostates feel better and reduce their urinary problems.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 50 Years to 80 Years |
| Sex | Male |
| Sponsor | Resurge Therapeutics Inc. (industry) |
| Drugs / interventions | chemotherapy |
| Locations | 4 sites (Wahroonga, New South Wales and 3 other locations) |
| Trial ID | NCT06136819 on ClinicalTrials.gov |
What this trial studies
The RT-310 study is a Phase 1 multi-center, non-randomized dose escalation trial aimed at evaluating the safety and feasibility of a novel implant, RT-310, for treating Benign Prostatic Hyperplasia (BPH). Participants, aged 50 to 80 years with symptomatic BPH, will receive the RT-310 implant and will be monitored for 180 days to assess outcomes. The study focuses on minimizing side effects while effectively managing lower urinary tract symptoms associated with prostate disease.
Who should consider this trial
Good fit: Ideal candidates are men aged 50 to 80 years with symptomatic BPH who have not adequately responded to or refused medical therapy.
Not a fit: Patients with a history of prostate or bladder cancer, urinary retention, or previous surgical interventions for BPH may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a safer and more effective option for men suffering from BPH.
How similar studies have performed: While this approach is novel, similar minimally invasive treatments for BPH have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Wahroonga, New South Wales and 3 other locations
- Australian Clinical Trials — Wahroonga, New South Wales, Australia (NOT_YET_RECRUITING)
- Goldfields Urology — Bendigo, Victoria, Australia (RECRUITING)
- Western Urology — Maribyrnong, Victoria, Australia (RECRUITING)
- Tauranga Urology Research — Tauranga, North Island, New Zealand (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: BPH, Lower Urinary Tract Symptoms