JALYN for Benign Prostatic Hyperplasia (BPH) and Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)

Benign Prostatic Hyperplasia Clinical Trial

Official title: A Multi-center Randomized Placebo Controlled Trial Evaluating the Efficacy of JALYN in Improving Symptoms in Men Diagnosed With Benign Prostatic Hyperplasia (BPH) and Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)

Status Terminated

Clinical Trial 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).

Clinical Trial Description

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 [1]. 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 [2]. 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 [3,4,5]. This particular subset of patients of BPH patients with prostatitis symptoms pose a therapeutic dilemma [6].

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) [7,8] and represents a significant percentage of urology outpatients (3-8% of male outpatient visits) [9,10] resulting in a major impact on quality of life of patients [11] and economic costs to society [12].

There are no good evidence based therapies for CP/CPPS [13,14], although there is some evidence available to consider 5 alpha reductase inhibitor and alpha blocker therapies [22]. There is an enormous unmet need to evaluate potential therapies for this condition.

Our current understanding of CP/CPPS patients are that they are a heterogeneous group of unique patients (the "snow flake" hypothesis) presenting with different clinical phenotypes [15]. We have proposed [16,17], validated [18] and recently proved that clinical phenotyping (using our UPOINT classification system) is possible and provides more effective treatment strategies [19].

There are studies that suggest that the same medical therapy that has proven effective for the treatment of BPH would also be beneficial for prostatitis like symptoms as well. A number of small pilot studies with finasteride [20], including a contemporary 6 month RCT [21], have strongly suggested that 5 ARI therapy may be effective in patients with CP/CPPS, but these studies were limited by study design including inclusion of all patients with the diagnosis of CP/CPPS (ages and clinical phenotypes that we now know could not possibly benefit from a 5ARI). REDUCE and many other epidemiology studies, have documented that men over 45 years old suffer from prostatitis and prostatitis symptoms [23]. REDUCE also clearly shows that dutasteride favorably impacts on prostatitis-like symptoms and men with prostatitis-like syndrome enrolled in that study [24]. In fact, the potential benefits suggested by extrapolating REDUCE results far outweigh any other intervention we have evaluated in any of the large North American NIH sponsored RCTs in the last decade [25,26,27]. A further sub-analyses of REDUCE shows that men with IPSS ≥ 8 and enlarged prostates (eg BPH) have a significant symptom benefit with dutasteride, irregardless of prostate size [28].These initial findings in REDUCE in patients not specifically diagnosed with CP/CPPS should be expanded to examine the benefits in a CP/CPPS population.

There are more clinical trials evaluating alpha blockers than any other therapy in CP/CPPS [22, 29]. While two North American RCTs [25,26] did not show benefit, 6 other alpha blocker randomized placebo controlled trials using validated contemporary outcomes were positive in terms of measureable benefits [30-35]. The latest clinical trial confirming the benefits of alpha blocker therapy in selected CP/CPPS patients (approximately 50 patients per arm in 12 week study) was recently published [35] and showed benefit, primarily in the LUTS symptom domain.

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) ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Chronic Disease
• Chronic Prostatitis
• Hyperplasia
• Pelvic Pain
• Prostatic Hyperplasia
• Prostatitis

• NCT number: NCT01830829
• Study type: Interventional
• Source: Queen's University
• Status: Terminated
• Phase: Phase 3
• Start date: April 2013
• Completion date: October 2014