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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)


Phase 3
45 Years
N/A
Open (Enrolling)
Male
Benign Prostatic Hyperplasia, Chronic Prostatitis

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Trial Information

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)


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)


Inclusion Criteria:



Men will be eligible for the study if:

1. age at least 45 years

2. report symptoms of discomfort or pain in the pelvic region during at least 3 of the
previous 6 months

3. total score of at least 12 (out of 43) points on the National Institutes of Health
Chronic Prostatitis Symptom Index (NIH-CPSI) at both a screening and randomization
visit

4. IPSS score of at least 8 points 5 tenderness on light palpation of the prostate

6. prostate size estimated to be at least 30cc on digital rectal examination

Exclusion Criteria:

Participants are excluded if

1. prior treatment with dutasteride or finasteride. Alpha blocker therapy within 3
months of randomization.

2. documented urinary tract infection (>105 colony forming units per ml of a recognized
uropathogen)

3. history of renal failure (or calculated creatinine clearance of < 60 ml/min)

4. symptomatic genital herpes in the last 3 months.

5. unilateral orchalgia without pelvic symptoms

6. a history of active urogenital cancer

7. active urethral stricture.

8. surgery of the lower urinary tract (not including simple diagnostic cystoscopy) in
the previous 6 months (including TURP, bladder neck incision, bladder tumor
resection, urethrotomy).

9. History of alcohol abuse

10. neurologic disease affecting voiding or the bladder

11. Psychiatric condition that would make it difficult (in opinion of investigator) for
patient to participate in the study

12. Other acute or chronic medical condition that would make it difficult (in opinion of
investigator) for patient to participate in the study

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Chronic Prostatitis Symptom Index (CPSI)

Outcome Description:

The primary endpoint will be the mean change in NIH CPSI from baseline in the treated group compared to the mean change in NIH CPSI from baseline in the placebo group at 6 months.

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

J. Curtis Nickel, MD FRCSC

Investigator Role:

Principal Investigator

Investigator Affiliation:

Queen's University

Authority:

Canada: Health Canada

Study ID:

JALYN

NCT ID:

NCT01830829

Start Date:

April 2013

Completion Date:

December 2014

Related Keywords:

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

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