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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06136819




Registration number
NCT06136819
Ethics application status
Date submitted
9/11/2023
Date registered
18/11/2023
Date last updated
13/11/2024

Titles & IDs
Public title
RT-310 Dose Escalation BPH Study
Scientific 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)
Secondary ID [1] 0 0
P18001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
BPH (Benign Prostatic Hyperplasia) 0 0
Lower Urinary Tract Symptoms 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - RT-310

Experimental: RT-310 Cohort 1 - Combination Product: RT-310 implant Cohort 1

Experimental: RT-310 Cohort 2 - Combination Product: RT-310 Implant Cohort 2


Other interventions: RT-310
Combination Product: RT-310 Implant for Investigational Treatment of Lower Urinary Tract Symptoms Secondary to BPH (Benign Prostatic Hyperplasia)

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
Baseline to Day 180
Secondary outcome [1] 0 0
Change in prostate volume
Timepoint [1] 0 0
Baseline to Day 180
Secondary outcome [2] 0 0
Change in IPSS
Timepoint [2] 0 0
Baseline to Day 180
Secondary outcome [3] 0 0
Uroflowmetry measure of Qmax
Timepoint [3] 0 0
Baseline to Day 180
Secondary outcome [4] 0 0
Uroflowmetry measure of Qave
Timepoint [4] 0 0
Baseline to Day 180
Secondary outcome [5] 0 0
Uroflowmetry measure of voided volume
Timepoint [5] 0 0
Baseline to Day 180
Secondary outcome [6] 0 0
PVR
Timepoint [6] 0 0
Baseline to Day 180

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
50 Years
Maximum age
80 Years
Sex
Males
Can healthy volunteers participate?
No
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, Rezum, 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Australian Clinical Trials - Wahroonga
Recruitment hospital [2] 0 0
Goldfields Urology - Bendigo
Recruitment hospital [3] 0 0
Western Urology - Maribyrnong
Recruitment postcode(s) [1] 0 0
2076 - Wahroonga
Recruitment postcode(s) [2] 0 0
3550 - Bendigo
Recruitment postcode(s) [3] 0 0
- Maribyrnong
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
North Island

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Resurge Therapeutics Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT06136819
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06136819