Prostate CancerNCT04130776
4Kscore Using Serum Stored Uncentrifuged
An observational study of Prostate Cancer, run by OPKO Health, Inc. at 1 site in United States.
Trial summary
The purpose of the study is to evaluate whether storage of serum uncentrifuged is an allowable preanalytical procedure Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Measurement of four prostate-specific kallikreins for the 4Kscore Test when serum stored uncentrifuged
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2017to 31 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- Men only
- Adult, Older adult
Study population: The study population will be 40 to 80 years old male whom have met all eligibility criteria
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
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
The purpose of the study is to evaluate whether storage of serum uncentrifuged is an allowable preanalytical procedure
- Conditions
- Prostate Cancer
- Being tested
- Measurement of four prostate-specific kallikreins for the 4Kscore Test when serum stored uncentrifuged
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of four prostate-specific kallikreins for the 4Kscore Test when serum stored uncentrifugedDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
tPSA changes in 3 days
Measure tPSA in serum samples at day 0, 1, 2 and 3
Measured: Day 0, 1, 2 and 3
fPSA changes in 3 days
Measure fPSA in serum samples at day 0, 1, 2 and 3
Measured: Day 0, 1, 2 and 3
iPSA changes in 3 days
Measure iPSA in serum samples at day 0, 1, 2 and 3
Measured: Day 0, 1, 2 and 3
hK2 changes in 3 days
Measure hK2 in serum samples at day 0, 1, 2 and 3
Measured: Day 0, 1, 2 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start4 Oct 2017
- Primary completion27 Mar 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- OPKO Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Ryan Mark, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04130776
- Sponsor's protocol ID
- 20622
- Status last verified
- Oct 2019
- First submitted
- 10 Oct 2019
- Last updated
- 17 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04130776
- Acronym / sponsor ID
- 20622
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- OPKO Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Oct 2017 (actual)
- Primary completion
- 27 Mar 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 17 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate whether storage of serum uncentrifuged is an allowable preanalytical procedure
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- The study population will be 40 to 80 years old male whom have met all eligibility criteria
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of four prostate-specific kallikreins for the 4Kscore Test when serum stored uncentrifugedThe 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. | Diagnostic test | – |
Primary outcome
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Ryan Mark principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by OPKO Health, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tPSA changes in 3 days (time frame: Day 0, 1, 2 and 3). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2019.