Benign Prostatic Hyperplasia (BPH) Screening Tool Case Finding Study in Subjects >=50 Years
Benign Prostatic Hyperplasia (BPH) Screening Tool Case Finding Study in Subjects >=50 Years
This non-randomized, interventional study will be conducted in a general practice setting to
 assess the utility of a benign prostatic enlargement (BPE)/benign prostatic obstruction (BPO)
 screening tool in conjunction with prostate specific antigen (PSA) in finding men confirmed
 to have BPH on full urologist assessment of diagnostic test results. The tool may help a
 General Practitioners (GP) to identify subjects who may have BPH for further tests and
 improve the speed of referrals to specialists when this is appropriate. The utility of the
 screening tool will be compared to the validated tool in wide clinical use, the International
 Prostate Symptom Score (IPSS). This study does not have any formal hypothesis in terms of the
 primary and secondary endpoint proportions. A BPE/BPO screening tool identifies lower urinary
 tract symptoms (LUTS) probably due to BPH in men not yet presenting with LUTS. The results of
 this screening tool will be used for further investigation. All subjects testing positive on
 the BPE/BPO screening tool (score >=3) tool or on the IPSS (score >=8) will be enrolled and
 offered a PSA test and urinalysis to establish a diagnosis of probable BPH (Part I-Visit 1).
 The GP may perform a digital rectal examination (DRE) which will be repeated by the urologist
 to confirm the diagnosis and to rule out an abnormality suggesting prostate cancer. The GP
 will make a diagnosis of probable BPH based upon screening results and lab tests which
 suggest that they are related to BPH and not other causes of such symptoms. The GP will phone
 the subject to report yes or no for probable BPH Part II (Visit 2). If the subject has
 probable BPH, the GP will schedule the subject for Visit 3 with an urologist. If the subject
 does not have probable BPH, then it will be considered that the subject has completed the
 study. Subjects that proceed to Part II (Visit 3) will be scheduled for a urology assessment
 performed by an urologist. This assessment includes a DRE and a brief physical exam and
 review of the PSA test, for a confirmatory diagnosis of BPH and estimation of risk of
 progression of BPH. Approximately 1,500 subjects presenting to a GP for reasons unrelated to
 this study will be screened for probable BPH to yield 500 subjects being referred to an
 urologist. The duration of the study will be 1 week (+/- 4 days) and up to 6 weeks to allow
 for GP and urologist visit scheduling.
Inclusion Criteria:

 -  Greater than or equal to (>=) 50 years of age at the time of signing the informed
 consent form.

 -  Male.

 -  Capable of giving signed informed consent which includes compliance with the
 requirements and restrictions listed in the consent form and protocol.

 -  Present in a General Practice setting for a reason unrelated to this study.

 -  Positive IPSS score >=8 and/or positive BPE/BPO screening tool score >=3.

 Exclusion Criteria:

 -  History of BPH for which they have received test procedures, medical intervention
 and/or medicine.

 -  History of prostate-related LUTS for which they have received test procedures, medical
 intervention and/or medicine.

 -  History of prostatic surgery (including transurethral resection of the prostate
 (TURP), balloon dilatation, thermotherapy, and/or stent replacement) or other invasive
 or minimally invasive procedures to treat BPH.

 -  Has other conditions that may cause urinary symptoms (e.g., neurogenic bladder,
 bladder neck contracture, urethral stricture, bladder malignancy, acute or chronic
 prostatitis, or acute or chronic urinary tract infections, etc.).

 -  History or evidence of prostate cancer (e.g., positive biopsy or ultrasound,
 suspicious DRE and/or rising PSA).

 -  Current or prior use of the following: 5alpha-reductase inhibitors (finasteride or
 dutasteride); anti-cholinergics (e.g. oxybutynin, propantheline, tolterodine,
 solifenacin, darifenacin, mirabegron) alpha-adrenoreceptor blockers (i.e., indoramin,
 prazosin, terazosin, tamsulosin, alfuzosin, doxazosin and silodosin), herbal products
 for urinary symptoms; Use of any investigational study drug within 30 days or 5
 half-lives of the drug in question, (whichever is longer), preceding the first study
 visit.

 -  Use within previous 30 days at Visit 1 of: phosphodiesterase type 5 inhibitor (PDE-5)
 inhibitors for erectile dysfunction; anabolic steroids