RT-310 Safety and Feasibility BPH Study

Resurge Therapeutics

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

BPH (Benign Prostatic Hyperplasia)

Treatments

Combination Product: RT-310

Study type

Interventional

Funder types

Industry

Identifiers

NCT07264205

P18003

Details and patient eligibility

About

RT-310, is intended to deliver drug locally to the prostate gland for the management of prostate disease, while minimizing systemic exposure and its associated side-effects. The objectives of the study are to assess whether RT-310 is safe and feasible for the participant population.

Enrollment

20 estimated patients

Sex

Male

Ages

50 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male gender
Diagnosis of symptomatic BPH
Age ≥ 50 years up to 80 years
International Prostate Symptom Score (IPSS) ≥ 13
Peak urine flow rate ≥ 5mL/sec and ≤ 12 ml/sec, voided volume ≥ 100 ml
Prostate volume 30 to 80 cc per ultrasound
Post void residual (PVR) urine ≤ 250 ml
Inadequate response and/or refusal of medical therapy for LUTS

Exclusion criteria

Unable or unwilling to sign the informed consent form (ICF) and/or comply with the study follow-up requirements
Current urinary retention requiring catheterization
Unwilling to abstain from unprotected sexual intercourse for 3 months
Unwilling to abstain from any child conceiving activities for 6 months
Have an obstructive or protruding median lobe of the prostate
High bladder neck determined by Investigator
Active urinary tract infection at time of treatment
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
Biopsy of the prostate within the past 6 weeks
Life expectancy estimated to be less than 1 year
History of prostate or bladder cancer, confirmed or suspected malignancy of prostate or bladder
History of compromised renal function or upper urinary tract disease
Known coagulopathies or participant on anticoagulants or antiplatelets other than aspirin ≤ 100 mg (unless antiplatelets are withheld minimum 3 days prior to procedure)
Use of the following medications pre-screening:

Within 6 months of baseline assessment, unless documented on stable dose for ≥ 12 months: 5-alpha-reductase inhibitors (e.g. dutasteride, Avodart, finasteride, Proscar, Propecia) Within 4 months of baseline assessment: estrogen, any drug producing androgen suppression, or anabolic steroids Within 2 weeks of baseline assessment: alpha-blockers, gonadotropin- releasing hormonal analogs, anticholinergics or cholinergic medication or phenylephrine, pseudoephedrine, diphenhydramine or imipramine medications Within 1 week of baseline assessment, unless documented on stable dose for ≥ 6 months: beta blockers, antidepressants, anticonvulsants, and antispasmodics

Cystolithiasis within the prior 3 months
History of co-morbidities that would affect having an elective urological procedure including prostatitis, conditions that preclude the RT-310.
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)
Currently enrolled in any other investigational clinical research trial that has not completed the primary endpoint.
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
Active or history of epididymitis within the past 3 months
Sensitivity to RT-310
Parkinson's disease or other neurologic disease that may impact bladder function such as stroke, TIA, multiple sclerosis
Active infection including prostatitis