Status:
ACTIVE_NOT_RECRUITING
RT-310 Dose Escalation BPH Study
Lead Sponsor:
Resurge Therapeutics Inc.
Conditions:
BPH (Benign Prostatic Hyperplasia)
Lower Urinary Tract Symptoms
Eligibility:
MALE
50-80 years
Phase:
PHASE1
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 as...
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 Hyperplas...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
April 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06136819
Start Date
April 19 2024
End Date
December 1 2027
Last Update
November 28 2025
Active Locations (4)
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1
Australian Clinical Trials
Wahroonga, New South Wales, Australia, 2076
2
Goldfields Urology
Bendigo, Victoria, Australia, 3550
3
Western Urology
Maribyrnong, Victoria, Australia
4
Tauranga Urology Research
Tauranga, North Island, New Zealand, 3112