Benign Prostatic Hyperplasia (BPH) Screening Tool Case Finding Study in Subjects >=50 Years

NCT02757963 | Completed Phase 4 Results

• 1 other identifier: 116114
• Study Type: interventional
• Target: 1,679
• Locations: 5 countries
• Sites: 45

Brief 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.

Conditions

Prostatic Hyperplasia

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

Outcome Measures

Primary Outcomes (1)

• Number of Men With Confirmed Diagnosis of BPH

  Confirmed diagnosis of BPH was based on full urologist diagnostic testing with a positive result on the BPE/BPO screening tool (score \>=3) and serum PSA \>=2 ng/mL. The BPE/BPO questionnaire consists of three questions each with a score ranging from 0= never experienced to 5= almost always experienced. Participants with probable BPH underwent full urologist diagnostic testing, which included review of medical history, symptoms and previous tests, brief physical examination, Digital rectal examination (DRE). Proportion of participants was calculated by dividing number of participants with a positive result on the BPE/BPO screening tool (Score \>= 3) and a diagnosis of BPH by the urologist (Numerator) by number of participants with a positive result on the BPE/BPO screening tool (Score \>= 3) and a BPH assessment by the urologist (Denominator). 95% confidence interval on the proportion was calculated by using the exact (Clopper-Pearson) method.

  Up to 6 weeks

Secondary Outcomes (4)

• Number of Men That Are Confirmed to Have BPH Based on Full Urologist Assessment of Diagnostic Test Results Among Men With a Positive Result on the IPSS, BPE/BPO and IPSS, and BPE/BPO or IPSS Screening Tools and Serum PSA >=2 ng/mL

  Up to 6 weeks

• Number of Men That Are Confirmed to be at Risk for BPH Progression Based Upon Full Urologist Assessment Among Men With a Positive Result on the BPE/BPO, IPSS, BPE/BPO and IPSS, and BPE/BPO or IPSS Screening Tools and Serum PSA >=2 ng/mL

  Up to 6 weeks

• Number of Men That Are Diagnosed With Probable BPH as Assessed by the GP Among Men With a Positive Result on the BPE/BPO, IPSS, BPE/BPO and IPSS, and BPE/BPO or IPSS Screening Tools

  Up to 6 weeks

• Summary of Agreement Between BPE/BPO and IPSS Screening Tools

  Day 1

Study Arms (1)

BPE/BPO screening and IPSS screening tool

OTHER

Subjects presenting to a GP with a primary complaint other than LUTS will be screened for probable BPH using BPE/BPO screening tool and the IPSS screening tool. Subjects testing positive on the BPE/BPO screening tool or on the IPSS will be enrolled and offered a prostate specific antigen (PSA) test and urinalysis to establish a diagnosis of probable benign prostatic hyperplasia (BPH) (Part I - Visit 1). If the GP determines that the subject has probable BPH (IPSS \>=8 and/or BPE/BPO questionnaire \>=3 with a PSA \>=2 ng per ml), the subject will proceed to Part II and will be scheduled for an urologist assessment and diagnostic tests to confirm or refute a BPH diagnosis and to assess risk of progression of BPH.

Other: Benign prostatic enlargement (BPE)/Benign prostatic obstruction (BPO) screening tool; Other: International Prostate Symptom Score (IPSS) screening tool

Interventions

Benign prostatic enlargement (BPE)/Benign prostatic obstruction (BPO) screening tool OTHER

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.

BPE/BPO screening and IPSS screening tool

International Prostate Symptom Score (IPSS) screening tool OTHER

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.

BPE/BPO screening and IPSS screening tool

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (45)

GSK Investigational Site

Aigrefeuille-sur-Maine, 44140, France

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GSK Investigational Site

Grenay, 62160, France

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GSK Investigational Site

Haute-Goulaine, 44115, France

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GSK Investigational Site

La Montagne, 44620, France

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GSK Investigational Site

Nantes, 44277, France

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GSK Investigational Site

Rosiers-d'Égletons, 19300, France

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GSK Investigational Site

Rouen, 76000, France

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GSK Investigational Site

Thouars, 79100, France

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GSK Investigational Site

Weinheim, Baden-Wurttemberg, 69469, Germany

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GSK Investigational Site

Munich, Bavaria, 80339, Germany

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GSK Investigational Site

Flörsheim, Hesse, 65439, Germany

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GSK Investigational Site

Buchholz, Lower Saxony, 21244, Germany

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GSK Investigational Site

Dippoldiswalde, Saxony, 01744, Germany

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GSK Investigational Site

Freital, Saxony, 01705, Germany

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GSK Investigational Site

Leipzig, Saxony, 04329, Germany

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GSK Investigational Site

Berlin, 10117, Germany

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GSK Investigational Site

Magdeburg, 39120, Germany

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GSK Investigational Site

Aradeo, Apulia, 73040, Italy

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GSK Investigational Site

Cutrofiano (LE), Apulia, 73020, Italy

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GSK Investigational Site

Galatina (LE), Apulia, 73013, Italy

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GSK Investigational Site

Ruffano (LE), Apulia, 73049, Italy

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GSK Investigational Site

Civitella Paganico (GR), Tuscany, 58045, Italy

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GSK Investigational Site

Grosseto, Tuscany, 58100, Italy

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GSK Investigational Site

Arkhangelsk, 163020, Russia

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GSK Investigational Site

Ivanovo, 153005, Russia

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GSK Investigational Site

Izhevsk, 426063, Russia

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GSK Investigational Site

Moscow, 123098, Russia

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GSK Investigational Site

Naro-Fominsk, 143300, Russia

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GSK Investigational Site

Novosibirsk, 630099, Russia

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GSK Investigational Site

Odintsovo, 143005, Russia

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GSK Investigational Site

Saint Petersburg, 195067, Russia

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GSK Investigational Site

Saint Petersburg, 195271, Russia

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GSK Investigational Site

Saint Petersburg, 198328, Russia

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GSK Investigational Site

Saint Petesburg, 195030, Russia

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GSK Investigational Site

Smolensk, 214031, Russia

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GSK Investigational Site

St'Petersburg, 197706, Russia

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GSK Investigational Site

Tomsk, 634 050, Russia

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GSK Investigational Site

Ulyanovsk, 432063, Russia

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GSK Investigational Site

Yaroslavl, 150000, Russia

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GSK Investigational Site

Bormujo (Sevilla), 41930, Spain

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GSK Investigational Site

Cadiz, 11009, Spain

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GSK Investigational Site

Granada, 18014, Spain

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GSK Investigational Site

Seville, 41014, Spain

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GSK Investigational Site

Valencia, 46010, Spain

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GSK Investigational Site

Valencia, 46026, Spain

Location

Related Publications (1)

• Tubaro A, Niero M, Adalig B, Lulic Z, Plastino J, Kimbrough C, Manyak MJ. Evaluation of a 3-item screening tool to identify men with benign prostatic enlargement/obstruction in a primary care cohort. Minerva Urol Nephrol. 2022 Feb;74(1):85-92. doi: 10.23736/S2724-6051.20.03834-5. Epub 2020 Sep 29.

  PMID: 32993275 BACKGROUND

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2016
• First Posted: May 2, 2016
• Study Start: May 12, 2016
• Primary Completion: February 27, 2017
• Study Completion: February 27, 2017
• Last Updated: January 5, 2021
• Results First Posted: June 24, 2019

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (copy the URL below to your browser)
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

DE (9); IT (6); FR (8); ES (6); RU (16)