RT-310 Dose Escalation BPH Study

Resurge Therapeutics

Status and phase

Active, not recruiting

Phase 1

Conditions

Lower Urinary Tract Symptoms

BPH (Benign Prostatic Hyperplasia)

Treatments

Combination Product: RT-310

Study type

Interventional

Funder types

Industry

Identifiers

NCT06136819

P18001

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

Male

Ages

50 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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