Configuration of a New Prostate Disease Nomogram Predicting Prostate Biopsy Outcome
Configuration of a New Prostate Disease Nomogram Predicting Prostate Biopsy Outcome
This study will identify significant clinical parameters and individual risk factors related
 to certain prostate disease (BPH, prostatitis and prostate cancer). With the identified
 important correlations, a locally generated bias free nomogram will be constructed for
 predicting prostate biopsy outcome among Asian men with indications for prostate biopsy.
 While this study will evaluate the accuracy and predictive value of this novel prostate
 disease nomogram.
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.
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