Configuration of a New Prostate Disease Nomogram Predicting Prostate Biopsy Outcome

NCT01826617 | Completed DMC

• 2 other identifiers: CT-13008SLMC CT-13008
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer; Prostatitis; Benign Prostatic Hyperplasia

Keywords

Prostate Disease Nomogram; Asian Men

Outcome Measures

Primary Outcomes (3)

• Incidence of prostate cancer (indolent vs aggressive type)

  Incidence of new diagnosed prostate cancer among patients with indication presented for first TRUS prostate biopsy at stone and prostate treatment center.

  1 year

• Incidence of prostatitis (acute vs chronic)

  Incidence of new diagnosed prostatitis among patients with indication presented for first TRUS prostate biopsy at stone and prostate treatment center.

  1 year

• Incidence of nodular hyperplasia (benign prostatic hyperplasia)

  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.

  1 year

Secondary Outcomes (1)

• Incidence of patient with synchronous occurrence of prostate diseases (benign prostatic hyperplasia, prostatitis, prostate cancer)

  1 year

Other Outcomes (9)

• Mean Age of patients with prostate cancer (PCA) or Prostatitis or BPH

  1 year

• Mean PSA value of patients with PCA, or Prostatitis or BPH

  1 year

• Mean BMI of patients with PCA, or Prostatitis or BPH

  1 year

Study Arms (5)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Luke's Medical Center, Philippines: lead

Study Sites (1)

Stone and Prostate Treatment Center- St. Luke's Medical Center, Philippines

Quezon City, National Capital Region, 1102, Philippines

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Prostatitis; Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Michael E. Chua, MD

  St. Luke's Medical Center, Philippines

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Staff Urologist

Study Record Dates

• First Submitted: April 1, 2013
• First Posted: April 8, 2013
• Study Start: December 1, 2010
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 7, 2015

Record last verified: 2015-04

Locations

PH (1)