NCT06136819

RT-310 Dose Escalation BPH Study

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)

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Resurge Therapeutics Inc. · Industry
• Sex: Male
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• BPH (Benign Prostatic Hyperplasia)
• Lower Urinary Tract Symptoms

Interventions

Type	Name	Description
COMBINATION_PRODUCT	RT-310	Combination Product: RT-310 Implant for Investigational Treatment of Lower Urinary Tract Symptoms Secondary to BPH (Benign Prostatic Hyperplasia)

Timeline

• Start date: 2024-04-19
• Primary completion: 2025-12-01
• Completion: 2027-12-01
• First posted: 2023-11-18
• Last updated: 2025-11-28

Locations

4 sites across 2 countries: Australia, New Zealand

Regulatory

• FDA-regulated drug study