BPH (Benign Prostatic Hyperplasia)Phase 1/2NCT07264205
RT-310 Safety and Feasibility BPH Study
A Phase 1/2 study testing RT-310 in people with BPH (Benign Prostatic Hyperplasia), run by Resurge Therapeutics Inc. at 1 site in Dominican Republic.
Trial summary
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. 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)
- What is being tested?
- RT-310
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDominican Republic
- Study dates
- 13 Mar 2025to Jun 2026
- Phase
- Phase 1/2
- 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
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Feasibility Study of RT-310 for Treatment of Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostatic Hyperplasia (BPH)
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.
- Conditions
- BPH (Benign Prostatic Hyperplasia)
- Being tested
- RT-310
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RT-310Combination product
RT-310
| Study group | Role | What they receive |
|---|---|---|
| RT-310 | Experimental | RT-310 Receives: Combination Product: RT-310 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Endpoint
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)
Measured: Baseline to Day 180
Secondary outcomes (2)
Change in IPSS
International Prostate Symptom Score (IPSS)
Measured: Baseline to Day 180
Uroflowmetry (Qmax)
Peak Urinary Flowrate (Qmax)
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 posted4 Dec 2025
- Study start13 Mar 2025
- Primary completionMar 2026 (estimated)
- Study completionJun 2026 (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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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
- NCT07264205
- Sponsor's protocol ID
- P18003
- Status last verified
- Nov 2025
- First submitted
- 24 Nov 2025
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility Study of RT-310 for Treatment of Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostatic Hyperplasia (BPH)
- ClinicalTrials.gov ID
- NCT07264205
- Acronym / sponsor ID
- P18003
- Conditions
- BPH (Benign Prostatic Hyperplasia)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Resurge Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Mar 2025 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 4 Dec 2025 (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, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RT-310 | Experimental | Combination Product: RT-310RT-310 |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (32 listed)
- 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
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-310RT-310 | Combination product | RT-310 |
Primary outcome
Safety Endpoint
Time frame: Baseline to Day 180
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)
2 secondary outcomes
Change in IPSS
Time frame: Baseline to Day 180
Uroflowmetry (Qmax)
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 20 Mar 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing RT-310 in people with BPH (Benign Prostatic Hyperplasia), run by Resurge Therapeutics Inc. at 1 site in Dominican Republic.
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 8 inclusion and 32 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 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Dominican Republic. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Safety Endpoint (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 20 Mar 2026.