RT-310 Safety and Feasibility BPH Study

NCT07264205 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: P18003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

BPH (Benign Prostatic Hyperplasia)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in IPSS

  Baseline to Day 180

• Uroflowmetry (Qmax)

  Baseline to Day 180

Study Arms (1)

RT-310

EXPERIMENTAL

RT-310

Combination Product: RT-310

Interventions

RT-310 COMBINATION_PRODUCT

RT-310

RT-310

Eligibility Criteria

• Age: 50 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Resurge Therapeutics Inc.: lead

Study Sites (1)

Research Site

Santo Domingo, Dominican Republic

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 4, 2025
• Study Start: March 13, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 20, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

DO (1)