Configuration of a New Prostate Disease Nomogram Predicting Prostate Biopsy Outcome

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by St. Luke's Medical Center, Philippines
Sponsor:
Information provided by (Responsible Party):
Michael E. Chua, St. Luke's Medical Center, Philippines
ClinicalTrials.gov Identifier:
NCT01826617
First received: April 1, 2013
Last updated: April 27, 2014
Last verified: April 2014
  Purpose

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.


Condition
Prostate Cancer
Prostatitis
Benign Prostatic Hyperplasia

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Year
Official Title: Configuration of a New Prostate Disease Nomogram Predicting Prostate Biopsy Outcome Correlating Clinical Indicators Among Asian Adult Males With Elevated Prostate Specific Antigen (PSA)

Resource links provided by NLM:


Further study details as provided by St. Luke's Medical Center, Philippines:

Primary Outcome Measures:
  • Incidence of prostate cancer (indolent vs aggressive type) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Incidence of new diagnosed prostate cancer among patients with indication presented for first TRUS prostate biopsy at stone and prostate treatment center.

  • Incidence of prostatitis (acute vs chronic) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Incidence of new diagnosed prostatitis among patients with indication presented for first TRUS prostate biopsy at stone and prostate treatment center.

  • Incidence of nodular hyperplasia (benign prostatic hyperplasia) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Incidence of patient with synchronous occurrence of prostate diseases (benign prostatic hyperplasia, prostatitis, prostate cancer) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Mean Age of patients with prostate cancer (PCA) or Prostatitis or BPH [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Mean PSA value of patients with PCA, or Prostatitis or BPH [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Mean BMI of patients with PCA, or Prostatitis or BPH [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Mean PSA density of patients with PCA, or Prostatitis or BPH [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Mean PSA velocity of patients with PCA, or Prostatitis or BPH [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Mean percent free PSA of patients with PCA, or Prostatitis or BPH [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Prevalence of positive family History of patients with Prostate cancer, or Prostatitis or BPH [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Prevalence of abnormal DRE of patients with PCA, or Prostatitis or BPH [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Prevalence of TRUS findings of patients with PCA, or Prostatitis or BPH [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: March 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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
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
Acute Prostatitis
Patient diagnosed with Acute prostatitis- according to histopathology description of Biopsy result
Chronic Prostatitis
Patient diagnosed with Chronic prostatitis- according to histopathology description of Biopsy result
Benign Prostatic Nodular Hyperplasia
Patient diagnosed with Benign Prostatic Nodular Hyperplasia- according to histopathology description of Biopsy result

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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 PSA level (>4.0ng/ml) or both.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01826617

Contacts
Contact: Michael E. Chua, MD 06327230101 ext 5425 auhc_ekim@yahoo.com
Contact: Jonathan Mendoza, MD jonathan_mendozamd@yahoo.com

Locations
Philippines
Stone and Prostate Treatment Center- St. Luke's Medical Center, Philippines Recruiting
Quezon City, National Capital Region, Philippines, 1102
Contact: Jonathan Mendoza, MD    06327230101 ext 5425    jonathan_mendozamd@yahoo.com   
Principal Investigator: Michael E Chua, MD         
Sponsors and Collaborators
St. Luke's Medical Center, Philippines
Investigators
Principal Investigator: Michael E. Chua, MD St. Luke's Medical Center, Philippines
  More Information

No publications provided

Responsible Party: Michael E. Chua, Medical Staff Urologist, St. Luke's Medical Center, Philippines
ClinicalTrials.gov Identifier: NCT01826617     History of Changes
Other Study ID Numbers: CT-13008, SLMC CT-13008
Study First Received: April 1, 2013
Last Updated: April 27, 2014
Health Authority: Philippines: Department of Health
Philippines: Ethics Committee
Philippines: Philippine Council for Health Research and Development

Keywords provided by St. Luke's Medical Center, Philippines:
Prostate Disease Nomogram
Asian Men

Additional relevant MeSH terms:
Prostatic Diseases
Prostatic Hyperplasia
Hyperplasia
Prostatic Neoplasms
Prostatitis
Genital Diseases, Male
Pathologic Processes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on July 23, 2014