Trial Review

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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
27/06/2024

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
19/04/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2025
Actual
Sample size
Target
20
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06136819