- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01826617
Configuration of a New Prostate Disease Nomogram Predicting Prostate Biopsy Outcome
Configuration of a New Prostate Disease Nomogram Predicting Prostate Biopsy Outcome Correlating Clinical Indicators Among Asian Adult Males With Elevated Prostate Specific Antigen (PSA)
Study Overview
Status
Detailed Description
This is a cross-sectional study prospectively collecting data from all patients who had their first Transrectal ultrasound (TRUS) prostate biopsy at the Stone and Prostate Treatment Center of St. Luke's Medical Center-Quezon City . Data will be collected uniformly for the purpose of building a clinical care prostate biopsy database. The indication for prostate biopsy is either a suspicious DRE findings or elevated Prostate specific antigen (PSA) level (>4.0ng/ml) or both. The clinical information gathered will include the 1. Identified risk factors (age, family history, race, Body Mass Index (BMI) - kg/cm2, prostatitis, and medications) 2. Clinical indicators of prostatic diseases (abnormal digital rectal examination, hypoechoic lesion on transrectal ultrasound), and 3. PSA (ng/ml) and its derivatives (age-specific PSA, PSA density, PSA velocity, Free PSA percentage). (Refer to Data Collection Form). Basic demographic data such as patient's height and weight will be measured using standard weight scale (Detecto 439 Mechanical Scale with Height rod, Webb City MO, USA). A urologist member of the team will perform DIgital Rectal Exam (DRE) on all patients before or after the TRUS. Serum free and total PSA level is measured at the Institute of Pathology using Siemens ADVIA Centaur Free PSA and PSA (Seimens Healthcare Diagnostics, USA) within a month prior to the prostate biopsy. Prior to prostate biopsy, the prostate will be scanned using a biplanar 7.5 Megahertz probe (GE Medical Systems Kretz Ultrasound, Zipf, Austria. Prostate volume is measured by a radiology technician [member of the staff team] of the center using the transverse and sagittal planes with the standard equation of measurement for prolate ellipsoid [width (w) x height (h) x length (l) x 0.523].
All prostate biopsy will uniformly required 12 cores (extended scheme) or more prostate tissue strips under ultrasound guidance with Fr 18 25cm biopsy device (Bard Urological, US), it is performed systematically to covers lateral and medial aspects of the apex, midgland and base of the right and left prostate lobes. Two additional biopsies are obtained if the ultrasound image or DRE findings indicate suspect areas.
All acquired specimens are placed in a formalin-filled container and sent for histopathologic examination. All specimens are examined by at least 2 board-certified pathologists at the Institute of Pathology to determine the presence of inflammation (acute/chronic prostatitis), other disease entity, or carcinoma (if positive for carcinoma, reading include grade using Gleason score, cancer length in biopsy specimen, percent of cancer involvement. All pathologists are blinded from the clinical indicators of the patients. An intermediate result is further subjected to immunohistostaining for a definitive conclusion. At least two pathologists are required to release the final report.
Data collection and extraction will use the pre-tested and standardized form. All collected forms will be submitted to the Clinical Information Service of St. Luke's Medical Center for encoding and preliminary analysis of incidence and prevalence. Additional analysis will be sent to a third party statistician for validation and reliability check.
Confidentiality of all data acquired will be assured. All patient record will be coded in the database as PIN. Patient name will not be included for encoding into the databank. Only the investigator team and clinical information service section of St. Luke's Medical Center will have access to the data set encoded. Hospital policy on safekeeping of the hospital record will be strictly followed and stored by Medical Record section of the medical center.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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National Capital Region
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Quezon City, National Capital Region, Philippines, 1102
- Stone and Prostate Treatment Center- St. Luke's Medical Center, Philippines
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All patients who had their first Transrectal ultrasound (TRUS) prostate biopsy at the Stone and Prostate Treatment Center of St. Luke's Medical Center-Quezon City . The indication for prostate biopsy is either a suspicious DRE findings or elevated PSA level (>4.0ng/ml) or both.
Exclusion Criteria:
- non-Asian patient
- incomplete data provided and patients refused to provide required data
- Prostate specific antigen done other than St. Luke's Medical Center
- did not consent for biopsy procedure
Study Plan
How is the study designed?
Design Details
- Observational Models: Ecologic or Community
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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Prostate Cancer- Indolent type
Patients diagnosed with Indolent type will be classified according to Epstein Criteria on histopathology results and National Comprehensive Cancer Network (NCCN) guideline recommended classification
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Prostate cancer- aggressive type
Patients diagnosed with aggressive type will be classified according to Epstein criteria on final histopathology findings and NCCN guideline recommended classification
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Acute Prostatitis
Patient diagnosed with Acute prostatitis- according to histopathology description of Biopsy result
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Chronic Prostatitis
Patient diagnosed with Chronic prostatitis- according to histopathology description of Biopsy result
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Benign Prostatic Nodular Hyperplasia
Patient diagnosed with Benign Prostatic Nodular Hyperplasia- according to histopathology description of Biopsy result
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of prostate cancer (indolent vs aggressive type)
Time Frame: 1 year
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Incidence of new diagnosed prostate cancer among patients with indication presented for first TRUS prostate biopsy at stone and prostate treatment center.
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1 year
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Incidence of prostatitis (acute vs chronic)
Time Frame: 1 year
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Incidence of new diagnosed prostatitis among patients with indication presented for first TRUS prostate biopsy at stone and prostate treatment center.
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1 year
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Incidence of nodular hyperplasia (benign prostatic hyperplasia)
Time Frame: 1 year
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Incidence of new diagnosed nodular hyperplasia (benign prostatic hyperplasia) among patients with indication presented for first TRUS prostate biopsy at stone and prostate treatment center.
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of patient with synchronous occurrence of prostate diseases (benign prostatic hyperplasia, prostatitis, prostate cancer)
Time Frame: 1 year
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Incidence of new diagnosed synchronous occurrences of prostate diseases (benign prostatic hyperplasia, prostatitis, prostate cancer) among patients with indication presented for first TRUS prostate biopsy at stone and prostate treatment center.
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1 year
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean Age of patients with prostate cancer (PCA) or Prostatitis or BPH
Time Frame: 1 year
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1 year
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Mean PSA value of patients with PCA, or Prostatitis or BPH
Time Frame: 1 year
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1 year
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Mean BMI of patients with PCA, or Prostatitis or BPH
Time Frame: 1 year
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1 year
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Mean PSA density of patients with PCA, or Prostatitis or BPH
Time Frame: 1 year
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1 year
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Mean PSA velocity of patients with PCA, or Prostatitis or BPH
Time Frame: 1 year
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1 year
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Mean percent free PSA of patients with PCA, or Prostatitis or BPH
Time Frame: 1 year
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1 year
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Prevalence of positive family History of patients with Prostate cancer, or Prostatitis or BPH
Time Frame: 1 year
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1 year
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Prevalence of abnormal DRE of patients with PCA, or Prostatitis or BPH
Time Frame: 1 year
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1 year
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Prevalence of TRUS findings of patients with PCA, or Prostatitis or BPH
Time Frame: 1 year
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1 year
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Collaborators and Investigators
Investigators
- Principal Investigator: Michael E. Chua, MD, St. Luke's Medical Center, Philippines
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CT-13008
- SLMC CT-13008 (Other Identifier: SLMC CT-13008)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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