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RT-310 Dose Escalation BPH Study

PHASE1RECRUITING

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.

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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.

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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

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Eligibility

Age eligible for study : 50 and older

Healthy volunteers accepted : No

Gender eligible for study: Male

Things to know

Study dates

Study start: 2024-04-19

Primary completion: 2024-10-01

Study completion finish: 2025-04-01

Study type

TREATMENT

Phase

PHASE1

Trial ID

NCT06136819

Intervention or treatment

COMBINATION_PRODUCT: RT-310

Conditions

• BPH (Benign Prostatic Hyperplasia)
• Lower Urinary Tract Symptoms

Image related to BPH (Benign Prostatic Hyperplasia)

Condition: BPH (Benign Prostatic Hyperplasia), Lower Urinary Tract Symptoms
COMBINATION_PRODUCT: RT-310
Wahroonga, New South Wales, Australia and more
Sponsor: Resurge Therapeutics Inc.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Australian Clinical Trials

Research sites nearby

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

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 implant Cohort 1	COMBINATION_PRODUCT: RT-310 Combination Product: RT-310 Implant for Investigational Treatment of Lower Urinary Tract Symptoms Secondary to BPH (Benign Prostatic Hyperplasia)
EXPERIMENTAL: RT-310 Cohort 2 Combination Product: RT-310 Implant Cohort 2	COMBINATION_PRODUCT: RT-310 Combination Product: RT-310 Implant for Investigational Treatment of Lower Urinary Tract Symptoms Secondary to BPH (Benign Prostatic Hyperplasia)

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome 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

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome 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

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

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References

Clinical Trials Gov: RT-310 Dose Escalation BPH Study