RT-310 Safety and Feasibility BPH Study

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

RT-310, is intended to deliver drug locally to the prostate gland for the management of prostate disease, while minimizing systemic exposure and its associated side-effects. The objectives of the study are to assess whether RT-310 is safe and feasible for the participant population.

Study Overview

• Status: Active, not recruiting
• Conditions: BPH (Benign Prostatic Hyperplasia)
• Intervention / Treatment: Combination product: RT-310

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Dominican Republic
  • Santo Domingo, Dominican Republic
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male gender
• Diagnosis of symptomatic BPH
• Age ≥ 50 years up to 80 years
• International Prostate Symptom Score (IPSS) ≥ 13
• Peak urine flow rate ≥ 5mL/sec and ≤ 12 ml/sec, voided volume ≥ 100 ml
• Prostate volume 30 to 80 cc per ultrasound
• Post void residual (PVR) urine ≤ 250 ml
• Inadequate response and/or refusal of medical therapy for LUTS

Exclusion Criteria:

• Unable or unwilling to sign the informed consent form (ICF) and/or comply with the study follow-up requirements
• Current urinary retention requiring catheterization
• Unwilling to abstain from unprotected sexual intercourse for 3 months
• Unwilling to abstain from any child conceiving activities for 6 months
• Have an obstructive or protruding median lobe of the prostate
• High bladder neck determined by Investigator
• Active urinary tract infection at time of treatment
• 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
• Biopsy of the prostate within the past 6 weeks
• Life expectancy estimated to be less than 1 year
• History of prostate or bladder cancer, confirmed or suspected malignancy of prostate or bladder
• History of compromised renal function or upper urinary tract disease
• Known coagulopathies or participant on anticoagulants or antiplatelets other than aspirin ≤ 100 mg (unless antiplatelets are withheld minimum 3 days prior to procedure)
• Use of the following medications pre-screening:

Within 6 months of baseline assessment, unless documented on stable dose for ≥ 12 months: 5-alpha-reductase inhibitors (e.g. dutasteride, Avodart, finasteride, Proscar, Propecia) Within 4 months of baseline assessment: estrogen, any drug producing androgen suppression, or anabolic steroids Within 2 weeks of baseline assessment: alpha-blockers, gonadotropin- releasing hormonal analogs, anticholinergics or cholinergic medication or phenylephrine, pseudoephedrine, diphenhydramine or imipramine medications Within 1 week of baseline assessment, unless documented on stable dose for ≥ 6 months: beta blockers, antidepressants, anticonvulsants, and antispasmodics

• Cystolithiasis within the prior 3 months
• History of co-morbidities that would affect having an elective urological procedure including prostatitis, conditions that preclude the RT-310.
• 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)
• Currently enrolled in any other investigational clinical research trial that has not completed the primary endpoint.
• 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
• Active or history of epididymitis within the past 3 months
• Sensitivity to RT-310
• Parkinson's disease or other neurologic disease that may impact bladder function such as stroke, TIA, multiple sclerosis
• Active infection including prostatitis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RT-310	Combination product: RT-310; RT-310

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Endpoint	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in IPSS	International Prostate Symptom Score (IPSS)	Baseline to Day 180
Uroflowmetry (Qmax)	Peak Urinary Flowrate (Qmax)	Baseline to Day 180

Collaborators and Investigators

• Sponsor: Resurge Therapeutics Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: November 24, 2025
• First Posted (Actual): December 4, 2025

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Hyperplasia
• Other Study ID Numbers: P18003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes