The purpose of this study is to evaluate the safety and efficacy of a single treatment of PRX302 for the treatment of Benign Prostatic Hyperplasia (BPH) as compared to placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
479
Efficacy
International Prostate Symptom Score (IPSS) total score change from baseline over 52 weeks.
Time frame: Week 52
Efficacy
Qmax change from baseline over 52 weeks.
Time frame: Week 52
Efficacy
IPSS total score change from baseline at each individual post-baseline timepoint.
Time frame: Week 52
Efficacy
Qmax change from baseline at each individual post-baseline timepoint.
Time frame: Week 52
Efficacy
IPSS "responders" at each individual post-baseline timepoint.
Time frame: Week 52
Efficacy
Qmax "responders" at each individual post-baseline timepoint.
Time frame: Week 52
Efficacy
Proportion of patients who receive rescue therapy.
Time frame: Week 52
Efficacy
Time to onset of rescue therapy.
Time frame: Week 52
Efficacy
Incidence rate for episodes of urinary retention.
Time frame: Week 52
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Unnamed facility
Huntsville, Alabama, United States
Unnamed facility
Anchorage, Alaska, United States
Unnamed facility
Laguna Hills, California, United States
Unnamed facility
Long Beach, California, United States
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Newport Beach, California, United States
Unnamed facility
San Diego, California, United States
Unnamed facility
San Diego, California, United States
Unnamed facility
Tarzana, California, United States
Unnamed facility
Denver, Colorado, United States
...and 66 more locations
Efficacy
Transition Zone (TZ) prostate volume change from baseline as measured by transrectal ultrasound (TRUS) at each individual post-baseline timepoint.
Time frame: Week 52
Efficacy
Total prostate volume (PV) change from baseline as measured by TRUS at each individual post-baseline timepoint.
Time frame: Week 52
Safety
Treatment-emergent adverse events (TEAEs).
Time frame: Week 52
Safety
Episodes of acute urinary retention as determined by the independent Adjudication Panel.
Time frame: Week 52
Safety
Assessment of sexual function for men who are sexually active using the International Index of Erectile Function - Erectile Function (IIEF-EF) and the Male Sexual Health Questionnaire© short form for ejaculatory dysfunction (MSHQ-EjD).
Time frame: Week 52
Safety
Physical examinations.
Time frame: Week 52
Safety
Vital signs.
Time frame: Week 52
Safety
Electrocardiograms (ECGs).
Time frame: Week 6
Safety
Laboratory parameters, consisting of chemistry panel, complete blood count (CBC), and urinalysis.
Time frame: Week 52
Safety
Measurement of anti-PRX302 antibodies (APA).
Time frame: Week 52
Safety
Serum concentration of PRX302 only if clinically indicated by an event such as suspected systemic toxicity.
Time frame: Week 52