RT-310 Dose Escalation BPH Study

Lower Urinary Tract Symptoms Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06136819
• Other study ID #: P18001
• Status: Recruiting
• Phase: Phase 1
• Start date: April 19, 2024
• Est. completion date: April 2025

Study information

• Verified date: May 2024
• Source: Resurge Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 80 Years

Eligibility

Key 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, Rezum, 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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Australia	Goldfields Urology	Bendigo	Victoria
Australia	Western Urology	Maribyrnong	Victoria
Australia	Australian Clinical Trials	Wahroonga	New South Wales
New Zealand	Tauranga Urology Research	Tauranga	North Island

Sponsors (1)

Lead Sponsor	Collaborator
Resurge Therapeutics Inc.

Countries where clinical trial is conducted

Australia,  New Zealand, 

Outcome

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