Last updated: 12/10/2020 13:50:04
Benign prostatic hyperplasia (BPH) screening tool case finding study in subjects >=50 years
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Implementation of a screening tool for subjects with benign prostatic enlargement/obstruction to identify men >=50 years presenting in General Practice with other co-morbidities who should be assessed for BPH
Trial description: 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.
Primary purpose:
Screening
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Number of men with confirmed diagnosis of BPH
Timeframe: Up to 6 weeks
Secondary outcomes:
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
Timeframe: 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
Timeframe: 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
Timeframe: Up to 6 weeks
Level of agreement between BPE/BPO and IPSS Screening Tools
Timeframe: Day 1
Interventions:
Other: Benign prostatic enlargement (BPE)/Benign prostatic obstruction (BPO) screening tool
Other: International Prostate Symptom Score (IPSS) screening tool
Enrollment:
1679
Observational study model:
Not applicable
Primary completion date:
2017-27-02
Time perspective:
Not applicable
Clinical publications:
Andrea Tubaro, Mauro Niero, Burkay Adalig, Zrinka Lulic, Janet Plastino, Carie Kimbrough, Michael J. Manyak. Evaluation of a 3-item screening tool to identify men presenting with benign prostatic enlargement/obstruction in primary care. Minerva Urol Nefrol. 2020;
DOI: 10.23736/S0393-2249.20.03834-5
Medical condition
Prostatic Hyperplasia
Product
dutasteride, dutasteride/tamsulosin, tamsulosin
Collaborators
Not applicable
Study date(s)
May 2016 to February 2017
Type
Interventional
Phase
4
Participation criteria
Sex
Male
Age
50+ years
Accepts healthy volunteers
No
- Greater than or equal to (>=) 50 years of age at the time of signing the informed consent form.
- Male.
- 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.
Inclusion and exclusion 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
Trial location(s)
Location
GSK Investigational Site
Buchholz, Niedersachsen, Germany, 21244
Status
Study Complete
Location
GSK Investigational Site
Civitella Paganico (GR), Toscana, Italy, 58045
Status
Study Complete
Location
GSK Investigational Site
Dippoldiswalde, Sachsen, Germany, 01744
Status
Study Complete
Location
GSK Investigational Site
Weinheim, Baden-Wuerttemberg, Germany, 69469
Status
Study Complete
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2017-27-02
Actual study completion date
2017-27-02
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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