Benign Prostatic Hyperplasia (BPH) Screening Tool Case Finding Study in Subjects >=50 Years
Condition: Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Intervention: Benign prostatic enlargement (BPE)/Benign prostatic obstruction (BPO) screening tool; International Prostate Symptom Score (IPSS) screening tool
Intervention description: The BPE/BPO screening tool has been developed using the currently recommended Food and Drug Administration (FDA) 2009 guidelines for developing patient-completed questionnaires such as Patient Reported Outcomes. The tool to be used in this study in the General Practice setting has undergone validation in a urology setting to demonstrate the validity of the tool in populations with and without a definite diagnosis of BPH. Subjects who have a positive score on the BPE/BPO screening tool (total score >=3) and meet all other eligibility requirements will be enrolled in Part I of the study.; The International Prostate Symptom Score (IPSS) score is a validated tool to assess the severity of LUTS symptoms, and has similarly been used for assessing symptomatic efficacy of treatments for BPH. Subjects who have a positive score on the IPSS tool (score >=8) and meet all other eligibility requirements will be enrolled in Part I of the study.
Phase: Phase 4
Study type: Interventional
Primary purpose: Screening
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1679.0
Sex: Male
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Screening tool; International Prostate Symptom Score; Lower urinary tract symptoms; BPO; BPE; Benign prostatic enlargement; Benign prostatic obstruction; LUTS; Benign prostatic hyperplasia; IPSS; BPH

Summary:

      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.
    

Eligibility criteria:

        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