Skip to main content
OpenTrials
Completed

NCT Number: NCT04130776

4Kscore Using Serum Stored Uncentrifuged

The purpose of the study is to evaluate whether storage of serum uncentrifuged is an allowable preanalytical procedure

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

40 year–80 year

Sex eligibility

Male

Study type

Observational

Primary location

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men capable of donating five 5 mL tubes of whole blood
  • 40 to 80 years old
  • No prior diagnosis of prostate cancer; prior negative prostate biopsy included
  • Total PSA (tPSA) value measured within last year to be: at 1.5 ng/mL to 4 ng/mL, 4.1 ng/mL to 10 ng/mL and 10 ng/mL and above

Exclusion criteria

  • In the previous 96 hours (4 days), underwent a digital rectal exam
  • Any invasive urologic procedure in the 6 months prior to study participation
  • Underwent any procedure to treat symptomatic benign prostatic hyperplasia in the last 6 months
  • Radical prostatectomy since tPSA measurement
  • Received within the previous 6 months 5-alpha reductase inhibitor (5-ARI) therapy such as Avodart (dutasteride) or Proscar (finasteride)

Treatment and study plan

Measurement of four prostate-specific kallikreins for the 4Kscore Test when serum stored uncentrifuged

Diagnostic Test

The 4Kscore Test helps clarify the biopsy decision-making process by determining a patient specific probability for finding aggressive, Gleason score 7 or higher prostate cancer upon biopsy. These are the aggressive prostate cancers that always require medical treatment or intervention. The 4Kscore Test relies on the measurement of four prostate-specific kallikreins in the blood: Total PSA, Free PSA, Intact PSA, and Human Kallikrein 2 (hK2). The blood test results are combined in an algorithm with patient age, digital rectal exam (nodules, no nodules), and prior negative biopsy (yes, no) to give physicians a personal score for each patient. The 4Kscore Test predicts the risk percent score from <1% to >95% of a man having aggressive cancer in a prospective biopsy.

Primary outcomes

  1. tPSA changes in 3 days

    Time frame: Day 0, 1, 2 and 3

    Measure tPSA in serum samples at day 0, 1, 2 and 3

  2. fPSA changes in 3 days

    Time frame: Day 0, 1, 2 and 3

    Measure fPSA in serum samples at day 0, 1, 2 and 3

  3. iPSA changes in 3 days

    Time frame: Day 0, 1, 2 and 3

    Measure iPSA in serum samples at day 0, 1, 2 and 3

  4. hK2 changes in 3 days

    Time frame: Day 0, 1, 2 and 3

    Measure hK2 in serum samples at day 0, 1, 2 and 3

Sponsors and collaborators

Lead sponsor

OPKO Health, Inc.

Industry

Registry information

Official study title

Demonstrating the Stability of the Analytes Measured for 4Kscore: Total PSA (tPSA), Free PSA (fPSA), Intact PSA (iPSA), and Human Kallikrein 2 (hk2) in Clinical Serum Samples Stored Uncentrifuged Before Testing

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 17, 2019
Registry last updated
Oct 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.