Trial Information

Configuration of a New Prostate Disease Nomogram Predicting Prostate Biopsy Outcome Correlating Clinical Indicators Among Asian Adult Males With Elevated Prostate Specific Antigen (PSA)

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.