RT-310 Dose Escalation BPH Study
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.
Study details:
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
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
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
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: MALE
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE1
Study ID
NCT06136819
Intervention or treatment
COMBINATION_PRODUCT: RT-310
Conditions
- BPH (Benign Prostatic Hyperplasia)
- Lower Urinary Tract Symptoms
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
Australian Clinical Trials
Select from list below to view details:
Australian Clinical Trials
Wahroonga, New South Wales, Australia
Goldfields Urology
Bendigo, Victoria, Australia
Western Urology
Maribyrnong, Victoria, Australia
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Who is running the clinical trial?
Resurge Therapeutics Inc.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: RT-310 Cohort 1
| Combination Product: RT-310 |
EXPERIMENTAL: RT-310 Cohort 2
| Combination Product: RT-310 |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| 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 Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Change in prostate volume | Transrectal ultrasound | Baseline to Day 180 |
| Change in IPSS | International Prostate Symptom Score (IPSS); IPSS scores range from 0 (no symptoms) to 35 (severe symptoms) | Baseline to Day 180 |
| Uroflowmetry measure of Qmax | Uroflowmetry measure of peak flow rate Qmax (mL/s) | Baseline to Day 180 |
| Uroflowmetry measure of Qave | Uroflowmetry measure of average flow rate, Qave (mL/s) | Baseline to Day 180 |
| Uroflowmetry measure of voided volume | Uroflowmetry measure of voided volume (mL) | Baseline to Day 180 |
| PVR | Post void residual (PVR) measurement | Baseline to Day 180 |
References
Clinical Trials Gov: RT-310 Dose Escalation BPH StudyOther trials to consider
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