BPH (Benign Prostatic Hyperplasia)Phase 1NCT06136819
RT-310 Dose Escalation BPH Study
A Phase 1 study testing RT-310 in people with BPH (Benign Prostatic Hyperplasia) and Lower Urinary Tract Symptoms, run by Resurge Therapeutics Inc. at 4 sites in 2 countries.
Trial 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 assess whether RT-310 is safe and feasible for the participant population. Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- BPH (Benign Prostatic Hyperplasia), Lower Urinary Tract Symptoms
- What is being tested?
- RT-310
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 19 Apr 2024to Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Australia3 sites
Goldfields Urology
Bendigo, Victoria, 3550
Western Urology
Maribyrnong, Victoria
Australian Clinical Trials
Wahroonga, New South Wales, 2076
About this study
Official title: Safety and Feasibility Dose Escalation Study for Evaluation of RT-310 for Treatment of Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostatic Hyperplasia (BPH)
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.
Read the 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 Hyperplasia (BPH). Study participants will have placement of RT-310 and be followed through 180 days.
- Being tested
- RT-310
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RT-310Combination product
Combination Product: RT-310 Implant for Investigational Treatment of Lower Urinary Tract Symptoms Secondary to BPH (Benign Prostatic Hyperplasia)
| Study group | Role | What they receive |
|---|---|---|
| RT-310 Cohort 1 | Experimental | Combination Product: RT-310 implant Cohort 1 Receives: Combination Product: RT-310 |
| RT-310 Cohort 2 | Experimental | Combination Product: RT-310 Implant Cohort 2 Receives: Combination Product: RT-310 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to Day 180
Secondary outcomes (6)
Change in prostate volume
Transrectal ultrasound
Measured: Baseline to Day 180
Change in IPSS
International Prostate Symptom Score (IPSS); IPSS scores range from 0 (no symptoms) to 35 (severe symptoms)
Measured: Baseline to Day 180
Uroflowmetry measure of Qmax
Uroflowmetry measure of peak flow rate Qmax (mL/s)
Measured: Baseline to Day 180
Uroflowmetry measure of Qave
Uroflowmetry measure of average flow rate, Qave (mL/s)
Measured: Baseline to Day 180
Uroflowmetry measure of voided volume
Uroflowmetry measure of voided volume (mL)
Measured: Baseline to Day 180
PVR
Post void residual (PVR) measurement
Measured: Baseline to Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start19 Apr 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPH (Benign Prostatic Hyperplasia)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Resurge Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06136819
- Sponsor's protocol ID
- P18001
- Status last verified
- Nov 2025
- First submitted
- 9 Nov 2023
- Last updated
- 28 Nov 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility Dose Escalation Study for Evaluation of RT-310 for Treatment of Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostatic Hyperplasia (BPH)
- ClinicalTrials.gov ID
- NCT06136819
- Acronym / sponsor ID
- P18001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Resurge Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Apr 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 Hyperplasia (BPH). Study participants will have placement of RT-310 and be followed through 180 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RT-310 Cohort 1 | Experimental | Combination Product: RT-310Combination Product: RT-310 implant Cohort 1 |
| RT-310 Cohort 2 | Experimental | Combination Product: RT-310Combination Product: RT-310 Implant Cohort 2 |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RT-310Combination Product: RT-310 Implant for Investigational Treatment of Lower Urinary Tract Symptoms Secondary to BPH (Benign Prostatic Hyperplasia) | Combination product | RT-310 Cohort 1, RT-310 Cohort 2 |
Primary outcome
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)
Time frame: Baseline to Day 180
Adverse events
6 secondary outcomes
Change in prostate volume
Time frame: Baseline to Day 180
Change in IPSS
Time frame: Baseline to Day 180
Uroflowmetry measure of Qmax
Time frame: Baseline to Day 180
Uroflowmetry measure of Qave
Time frame: Baseline to Day 180
Uroflowmetry measure of voided volume
Time frame: Baseline to Day 180
PVR
Time frame: Baseline to Day 180
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RT-310 in people with BPH (Benign Prostatic Hyperplasia) and Lower Urinary Tract Symptoms, run by Resurge Therapeutics Inc. at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: Baseline to Day 180). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.