RT-310 Dose Escalation BPH Study

Phase 1

Recruiting

• Conditions: BPH (Benign Prostatic Hyperplasia); Lower Urinary Tract Symptoms
• Interventions: Combination Product: RT-310

• Registration Number: NCT06136819
• Lead Sponsor: Resurge Therapeutics Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2023-11-09
• Study First Submitted QC: 2023-11-13
• Study First Posted: 2023-11-18
• Study Start: 2024-04-19
• Status Verified: 2024-06
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-13
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
RT-310 Cohort 1	RT-310	Combination Product: RT-310 implant Cohort 1
RT-310 Cohort 2	RT-310	Combination Product: RT-310 Implant Cohort 2

Primary Outcome Measures

Name	Time	Method
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	Adverse events

Secondary Outcome Measures

Name	Time	Method
Change in prostate volume	Baseline to Day 180	Transrectal ultrasound
PVR	Baseline to Day 180	Post void residual (PVR) measurement
Uroflowmetry measure of Qmax	Baseline to Day 180	Uroflowmetry measure of peak flow rate Qmax (mL/s)
Uroflowmetry measure of voided volume	Baseline to Day 180	Uroflowmetry measure of voided volume (mL)
Uroflowmetry measure of Qave	Baseline to Day 180	Uroflowmetry measure of average flow rate, Qave (mL/s)
Change in IPSS	Baseline to Day 180	International Prostate Symptom Score (IPSS); IPSS scores range from 0 (no symptoms) to 35 (severe symptoms)

Trial Locations

Locations (4)

Australian Clinical Trials; 🇦🇺 Wahroonga, New South Wales, Australia

Goldfields Urology; 🇦🇺 Bendigo, Victoria, Australia

Tauranga Urology Research; 🇳🇿 Tauranga, North Island, New Zealand

Western Urology; 🇦🇺 Maribyrnong, Victoria, Australia