Prostate CancerPROSTest_STRATNCT07454603
A Single-arm, Multicenter Prospective Study to Evaluate the Diagnostic Performance of PROSTest in Men With PSA ≥ 3ng/ml Using Biopsy as the Sole Ground Truth
An observational study of Prostate Cancer and Urology, run by Wren Laboratories LLC at 1 site in United States.
Trial summary
This prospective observational study will enroll men referred for prostate biopsy due to elevated PSA and/or abnormal digital rectal examination, with or without pre-biopsy MRI. Peripheral blood will be collected prior to biopsy for PROSTest analysis. Biopsy histopathology will serve as the reference standard. Read more about this study
- Who is it for?
- Ages 45 to 80 years, men only
- Conditions the study is for
- Prostate Cancer, Urology, Prostate Cancer (Diagnosis)
- What is being tested?
- PROSTEST
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2026to 1 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 45 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men at risk for PCa based on age and or elevated PSA/abnormal DRE.
Who may be able to join
- elevated PSA and/or abnormal digital rectal examination
Who cannot join
- Previous Prostate cancer diagnosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wren Laboratories
Branford, Connecticut, 06405
Mark Kidd, PhD, 2038241128, mkidd@wrenlaboratories.com
Tracy Auster, BS, 2032083464, tauster@wrenlaboratories.com
About this study
This prospective observational study will enroll men referred for prostate biopsy due to elevated PSA and/or abnormal digital rectal examination, with or without pre-biopsy MRI. Peripheral blood will be collected prior to biopsy for PROSTest analysis. Biopsy histopathology will serve as the reference standard. PROSTest results will be analyzed blinded to pathology.
Read the detailed description
This prospective observational study will enroll men referred for prostate biopsy due to elevated PSA and/or abnormal digital rectal examination, with or without pre-biopsy MRI. Peripheral blood will be collected prior to biopsy for PROSTest analysis. Biopsy histopathology will serve as the reference standard. PROSTest results will be analyzed blinded to pathology. Diagnostic performance metrics including sensitivity, specificity, negative predictive value, and area under the receiver operating characteristic curve will be calculated. Decision-curve analyses will assess potential reductions in unnecessary biopsies. Exploratory analyses will evaluate correlations between PROSTest scores, MRI findings, and pathologic grade group.
Endpoints: Primary endpoint is diagnostic accuracy of PROSTest for PCa detection. Secondary endpoints include negative predictive value, correlation with Gleason grade group, and incremental performance of PROSTest when combined with PSA and MRI.
Trial Status: IRB approval is complete. Enrollment is expected to begin in March 2026, with a planned sample size of approximately [1,500] participants.
- Conditions
- Prostate Cancer, Urology, Prostate Cancer (Diagnosis)
- Being tested
- PROSTEST
- Keywords
- BIOPSY, MRI, PROSTATE CANCER
- Medical subject headings
- Prostatic Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROSTESTDiagnostic test
BLOOD SAMPLE FOR PROSTEST MEASUREMENT
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of the PROSTest to detect prostate cancer at biopsy
Primary endpoint is diagnostic accuracy of PROSTest for PCa detection. Assay is scored 0-100 and has a cut-off of 50 for normal. A blood sample with a PROSTest score > or equal than 50 are predicted to be a prostate cancer. The expectation is that >85% of individuals who are biopsy positive are also PROSTest-positive. We anticipate ~400 individuals will be biopsy positive. Conversely, the expectation is that >75% of individuals who are biopsy negative will also be PROSTest-negative. We anticipate ~600 individuals will be biopsy negative. This will allow us to derive diagnostic metrics for the assay using biopsy-status as the gold standard.
Measured: Following completion of the study. Study is anticipated to enroll over a year and be completed within 18 months. Samples will be evaluated at study end.
Secondary outcomes (1)
Diagnostics metrics for the PROSTest
Secondary endpoint includes investigating whether there is a correlation between the PROSTest score (scaled 0-100) and the Gleason grade group.
Measured: Following completion of the study. Study is anticipated to enroll over a year and be completed within 18 months. Samples will be evaluated at study end.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start15 Apr 2026
- Primary completion28 Feb 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wren Laboratories LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Abdel Halim, PharmD, PhD, Study chair, Wren Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07454603
- Sponsor's protocol ID
- WREN_REGISTER_03
- Other IDs
- WREN_010
- Acronym
- PROSTest_STRAT
- Status last verified
- Aug 2026
- First submitted
- 2 Feb 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We are establishing a DFR for this.
Publications
Rogers CG, Koduru SV, Gulati A, Halim AB. PROSTest, a Novel Liquid Biopsy Molecular Assay, Accurately Guides Prostate Cancer Biopsy Decision-Making in Men with Elevated PSA Irrespective of DRE Findings. Cancers (Basel). 2025 Dec 6;17(24):3908. doi: 10.3390/cancers17243908.
PubMed 41463159Kidd M, Rempega G, Kepinski M, Slomian S, Mlynarek K, Halim AB. Utility of the PROSTest, a Novel Blood-Based Molecular Assay, Versus PSA for Prostate Cancer Stratification and Detection of Disease. Prostate. 2026 Feb;86(3):307-313. doi: 10.1002/pros.70086. Epub 2025 Oct 23.
PubMed 41129487Rahbar K, Rosin RD, Kidd M, Halim AB, Sartor O. PROSTest, a Multigene Liquid Biopsy Signature, Effectively Stratifies Patients With High PSA for Prostate Biopsy. Prostate. 2026 Jan;86(1):43-52. doi: 10.1002/pros.70052. Epub 2025 Sep 19.
PubMed 40970770Rahbar K, Kidd M, Prasad V, David Rosin R, Drozdov I, Halim A. Clinical Sensitivity and Specificity of the PROSTest in an American Cohort. Prostate. 2025 May;85(6):558-566. doi: 10.1002/pros.24858. Epub 2025 Jan 21.
PubMed 39838708
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Multicenter Prospective Study to Evaluate the Diagnostic Performance of PROSTest in Men With PSA ≥ 3ng/ml Using Biopsy as the Sole Ground Truth
- ClinicalTrials.gov ID
- NCT07454603
- Acronym / sponsor ID
- PROSTest_STRAT / WREN_REGISTER_03
- Conditions
- Prostate Cancer, Urology, Prostate Cancer (Diagnosis)
- Keywords
- BIOPSY, MRI, PROSTATE CANCER
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Wren Laboratories LLCIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 6 Mar 2026 (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.
This prospective observational study will enroll men referred for prostate biopsy due to elevated PSA and/or abnormal digital rectal examination, with or without pre-biopsy MRI. Peripheral blood will be collected prior to biopsy for PROSTest analysis. Biopsy histopathology will serve as the reference standard. PROSTest results will be analyzed blinded to pathology.
Detailed description
This prospective observational study will enroll men referred for prostate biopsy due to elevated PSA and/or abnormal digital rectal examination, with or without pre-biopsy MRI. Peripheral blood will be collected prior to biopsy for PROSTest analysis. Biopsy histopathology will serve as the reference standard. PROSTest results will be analyzed blinded to pathology. Diagnostic performance metrics including sensitivity, specificity, negative predictive value, and area under the receiver operating characteristic curve will be calculated. Decision-curve analyses will assess potential reductions in unnecessary biopsies. Exploratory analyses will evaluate correlations between PROSTest scores, MRI findings, and pathologic grade group.
Endpoints: Primary endpoint is diagnostic accuracy of PROSTest for PCa detection. Secondary endpoints include negative predictive value, correlation with Gleason grade group, and incremental performance of PROSTest when combined with PSA and MRI.
Trial Status: IRB approval is complete. Enrollment is expected to begin in March 2026, with a planned sample size of approximately [1,500] participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men at risk for PCa based on age and or elevated PSA/abnormal DRE.
Key inclusion criteria (1 listed)
- elevated PSA and/or abnormal digital rectal examination
Key exclusion criteria (1 listed)
- Previous Prostate cancer diagnosis
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 |
|---|---|---|
| PROSTESTBLOOD SAMPLE FOR PROSTEST MEASUREMENT | Diagnostic test | – |
Primary outcome
Diagnostic accuracy of the PROSTest to detect prostate cancer at biopsy
Time frame: Following completion of the study. Study is anticipated to enroll over a year and be completed within 18 months. Samples will be evaluated at study end.
Primary endpoint is diagnostic accuracy of PROSTest for PCa detection. Assay is scored 0-100 and has a cut-off of 50 for normal. A blood sample with a PROSTest score > or equal than 50 are predicted to be a prostate cancer. The expectation is that >85% of individuals who are biopsy positive are also PROSTest-positive. We anticipate ~400 individuals will be biopsy positive. Conversely, the expectation is that >75% of individuals who are biopsy negative will also be PROSTest-negative. We anticipate ~600 individuals will be biopsy negative. This will allow us to derive diagnostic metrics for the assay using biopsy-status as the gold standard.
1 secondary outcome
Diagnostics metrics for the PROSTest
Time frame: Following completion of the study. Study is anticipated to enroll over a year and be completed within 18 months. Samples will be evaluated at study end.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Background: PubMed 41463159Rogers CG, Koduru SV, Gulati A, Halim AB. PROSTest, a Novel Liquid Biopsy Molecular Assay, Accurately Guides Prostate Cancer Biopsy Decision-Making in Men with Elevated PSA Irrespective of DRE Findings. Cancers (Basel). 2025 Dec 6;17(24):3908. doi: 10.3390/cancers17243908.
- Background: PubMed 41129487Kidd M, Rempega G, Kepinski M, Slomian S, Mlynarek K, Halim AB. Utility of the PROSTest, a Novel Blood-Based Molecular Assay, Versus PSA for Prostate Cancer Stratification and Detection of Disease. Prostate. 2026 Feb;86(3):307-313. doi: 10.1002/pros.70086. Epub 2025 Oct 23.
- Background: PubMed 40970770Rahbar K, Rosin RD, Kidd M, Halim AB, Sartor O. PROSTest, a Multigene Liquid Biopsy Signature, Effectively Stratifies Patients With High PSA for Prostate Biopsy. Prostate. 2026 Jan;86(1):43-52. doi: 10.1002/pros.70052. Epub 2025 Sep 19.
- Background: PubMed 39838708Rahbar K, Kidd M, Prasad V, David Rosin R, Drozdov I, Halim A. Clinical Sensitivity and Specificity of the PROSTest in an American Cohort. Prostate. 2025 May;85(6):558-566. doi: 10.1002/pros.24858. Epub 2025 Jan 21.
- Individual participant dataSharing planned: Undecided. We are establishing a DFR for this.
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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.
Abdel Halim, PharmD, PhD study chair
Wren Laboratories
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 and Urology, run by Wren Laboratories LLC 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 21 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark Kidd, PhD (2038241128, mkidd@wrenlaboratories.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of the PROSTest to detect prostate cancer at biopsy (time frame: Following completion of the study. Study is anticipated to enroll over a year and be completed within 18 months. Samples will be evaluated at study end.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07454603, which also lists 4 linked publications.
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 21 Aug 2026.