This randomized, double-blind, placebo-controlled Phase 2 study is evaluating Teverelix DP in men following a first episode of acute urinary retention (AUR) associated with benign prostatic hyperplasia (BPH), a population at risk of recurrent urinary retention and subsequent surgical or minimally invasive intervention.
The study is designed to evaluate the effects of Teverelix DP on total prostate volume and urinary function and to prospectively evaluate clinically meaningful outcomes including recurrent AUR, BPH-related surgical or minimally invasive intervention, protocol-defined treatment failure and clinical benefit.
Participants will be randomized to one of four treatment groups evaluating two active Teverelix DP regimens: 90 mg administered intramuscularly (IM) and 120 mg administered subcutaneously (SC) and their respective matched placebo controls.
The primary endpoint is percent change from baseline in total prostate volume (TPV) at Week 12. Participants will continue to be evaluated during the 28-week treatment period for urinary function and prospectively defined clinical outcomes, including recurrent AUR, BPH-related intervention, treatment failure and clinical benefit, and will be followed through Week 52 for protocol-defined longer-term assessments and safety follow-up.
The study is designed to characterize biological activity, urinary function, clinical outcomes, safety and the relative treatment effects of the two Teverelix DP regimens to inform dose and route selection and subsequent clinical development.
Inclusion Criteria:
Male aged 45 years or older
Having given his written consent
Successful TWOC as defined by successful voiding with a minimum residual volume
Having had a first episode of spontaneous acute urinary retention within 6 days of study screening visit.
Prostate volume >40 g (assessed by TRUS)
Patients may initiate or continue alpha-blocker therapy at or before randomization. The same agent and dose should be continued throughout the treatment period where possible
Agrees to practice contraception during the entire study treatment period and for 3 months after the last dose of IMP is administered:
i. Note: Periodic abstinence [e.g. calendar, ovulation, symptothermal, postovulation methods for the female partner with childbearing potential] and withdrawal are not acceptable methods of contraception.
Must be treatment naïve to GnRH analogues
Exclusion Criteria:
Participated in another investigational study within 3 months before recruitment
AUR due to i.e. postoperative retention following major abdominal/pelvis/spinal surgery
Neurological related AUR
Contraindication to the use of alpha blockers
Previous prostate or urethral surgery
Previous histological or clinical diagnosis of prostate cancer
Any unstable co-existing medical condition
Has abnormal screening and/or baseline laboratory values that suggest a clinically significant underlying disease, or the following laboratory values:
Has congenital long QT syndrome or ECG abnormalities at screening of:
Note: Cardiac arrhythmia grading:
History or current evidence of alcohol or drug abuse within the last 12 months
Prostate Specific Antigen (PSA) greater than 20ng/ml
Use of suprapubic catheterization after failed urethral catheterization
Neurogenic bladder dysfunction, confirmed or suspected, irrespective of etiology
Isolated bladder neck disease
Acute or chronic prostatitis
Confirmed or suspected urethral stricture
Known bladder stones
Use of the following medications prior to and during study participation:
rchowdhury@antev.co.uk+4407491167075
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