Clinical trial NCT06136819: RT-310 Dose Escalation BPH Study
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: BPH (Benign Prostatic Hyperplasia)
Lower Urinary Tract Symptoms
Lead sponsor: Resurge Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2023-11-18
Enrollment: 20
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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, 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

Primary outcomes:
measure: 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)
timeFrame: Baseline to Day 180
Secondary outcomes:
measure: Change in prostate volume
timeFrame: Baseline to Day 180
measure: Change in IPSS
timeFrame: Baseline to Day 180
measure: Uroflowmetry measure of Qmax
timeFrame: Baseline to Day 180
measure: Uroflowmetry measure of Qave
timeFrame: Baseline to Day 180
measure: Uroflowmetry measure of voided volume
timeFrame: Baseline to Day 180
measure: PVR
timeFrame: Baseline to Day 180
Other outcomes:
Locations:
city: Wahroonga
country: Australia
facility: Australian Clinical Trials
state: New South Wales
city: Bendigo
country: Australia
facility: Goldfields Urology
state: Victoria
city: Maribyrnong
country: Australia
facility: Western Urology
state: Victoria
city: Tauranga
country: New Zealand
facility: Tauranga Urology Research
state: North Island
Study officials:
References: