JALYN for Benign Prostatic Hyperplasia (BPH) and Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
Status:
Terminated
Trial end date:
2014-10-01
Target enrollment:
Participant gender:
Summary
Benign Prostatic Hyperplasia (BPH) describes a common medical condition in men over 45
associated with voiding (obstructive) and storage (irritative) lower urinary tract symptoms
and is in part related to prostate enlargement and obstruction. The standard medical therapy
for this condition includes 5-alpha reductase inhibitors -5ARI (eg dutasteride) or alpha
blocker therapy (eg tamsulosin), while the most effective medical therapy for BPH is the
combination of these two medications. Approximately 10 to 20% of patients diagnosed with BPH
also have either a diagnosis of or symptoms of chronic prostatitis/chronic pelvic pain
syndrome (CP/CPPS) with typical genito-urinary pain and discomfort. This particular subset of
patients of BPH patients with prostatitis symptoms pose a therapeutic dilemma. CP/CPPS (organ
specific phenotype) is the third most prevalent prostate disease after prostate cancer and
BPH. CP/CPPS is very prevalent (3-9% of men) and represents a significant percentage of
urology outpatients (3-8% of male outpatient visits)resulting in a major impact on quality of
life of patients and economic costs to society. Clinical phenotyping allows for prediction of
the patients with CP/CPPS most likely to respond to dutasteride and tamsulosin (age, Lower
Urinary Tract Symptoms [LUTS] and prostate related phenotypes [BPH]). It can be estimated
that up to 30% of men currently diagnosed with CP/CPPS will include men with co-existing
Benign Prostatic Hyperplasia (BPH) We propose to determine the efficacy of JALYN
(dutasteride-tamsulosin combination) in the amelioration of prostatitis symptoms in men
diagnosed with CP/CPPS who have the following clinical phenotype; age = 45 years, Lower
Urinary Tract Symptoms (LUTS), enlarged prostate and Organ (prostate) specific symptoms (eg.
BPH and CP/CPPS).
Phase:
Phase 3
Details
Lead Sponsor:
Dr. J. Curtis Nickel
Collaborators:
The Cleveland Clinic University of California, Los Angeles