RT-310 Dose Escalation BPH Study

NCT06136819 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: P18001
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 4

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.

Conditions

BPH (Benign Prostatic Hyperplasia); Lower Urinary Tract Symptoms

Outcome Measures

Primary Outcomes (1)

• 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)

  Adverse events

  Baseline to Day 180

Secondary Outcomes (6)

• Change in prostate volume

  Baseline to Day 180

• Change in IPSS

  Baseline to Day 180

• Uroflowmetry measure of Qmax

  Baseline to Day 180

• Uroflowmetry measure of Qave

  Baseline to Day 180

• Uroflowmetry measure of voided volume

  Baseline to Day 180

Study Arms (2)

RT-310 Cohort 1

EXPERIMENTAL

Combination Product: RT-310 implant Cohort 1

Combination Product: RT-310

RT-310 Cohort 2

EXPERIMENTAL

Combination Product: RT-310 Implant Cohort 2

Combination Product: RT-310

Interventions

RT-310 COMBINATION_PRODUCT

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

RT-310 Cohort 1; RT-310 Cohort 2

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
• Prostate volume 30 to 80 cc per ultrasound
• Inadequate response and/or refusal of medical therapy for LUTS

You may not qualify if:

• 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

Sponsors & Collaborators

• Resurge Therapeutics Inc.: lead

Study Sites (4)

Australian Clinical Trials

Wahroonga, New South Wales, 2076, Australia

Location

Goldfields Urology

Bendigo, Victoria, 3550, Australia

Location

Western Urology

Maribyrnong, Victoria, Australia

Location

Tauranga Urology Research

Tauranga, North Island, 3112, New Zealand

Location

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: November 18, 2023
• Study Start: April 19, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 28, 2025

Record last verified: 2025-11

Locations

AU (3); NZ (1)