4Kscore Using Serum Stored Uncentrifuged

Prostate Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04130776
• Other study ID #: 20622
• Status: Completed
• Start date: October 4, 2017
• Est. completion date: October 31, 2018

Study information

• Verified date: October 2019
• Source: OPKO Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: October 31, 2018
• Est. primary completion date: March 27, 2018
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Sidney Kimmel Cancer Center at Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
OPKO Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tPSA changes in 3 days	Measure tPSA in serum samples at day 0, 1, 2 and 3	Day 0, 1, 2 and 3
Primary	fPSA changes in 3 days	Measure fPSA in serum samples at day 0, 1, 2 and 3	Day 0, 1, 2 and 3
Primary	iPSA changes in 3 days	Measure iPSA in serum samples at day 0, 1, 2 and 3	Day 0, 1, 2 and 3
Primary	hK2 changes in 3 days	Measure hK2 in serum samples at day 0, 1, 2 and 3	Day 0, 1, 2 and 3