RT-310 Dose Escalation BPH Study

NCT ID: NCT06136819

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-19
• Study Completion Date: 2027-12-31

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.

Conditions

BPH (Benign Prostatic Hyperplasia); Lower Urinary Tract Symptoms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RT-310 Cohort 1

Combination Product: RT-310 implant Cohort 1

Group Type: EXPERIMENTAL

RT-310

Intervention Type: COMBINATION_PRODUCT

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

RT-310 Cohort 2

Combination Product: RT-310 Implant Cohort 2

Group Type: EXPERIMENTAL

RT-310

Intervention Type: COMBINATION_PRODUCT

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

Interventions

RT-310

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

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Resurge Therapeutics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Australian Clinical Trials

Wahroonga, New South Wales, Australia

Goldfields Urology

Bendigo, Victoria, Australia

Western Urology

Maribyrnong, Victoria, Australia

Tauranga Urology Research

Tauranga, North Island, New Zealand

Countries

Australia; New Zealand

Other Identifiers

P18001

Identifier Type: -

Identifier Source: org_study_id