PSAMDSelectNCT04240327
Marker Driven Selection of Patients for Prostate Biopsy and Management
An observational study of PSA and Elevated PSA, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this research study is to determine if the interpretation of multiparametric MRI (mpMRI) with an algorithm called habitat risk score (HRS) in combination with a panel of blood and urine biomarkers is more effective at detecting prostate cancer than standard of care interpretation of mpMRI with the… Read more about this study
- Who is it for?
- Ages 40 to 85 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- PSA, Elevated PSA, Prostate Cancer
- How many people
- 289 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2020to 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 40 to 85 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study participants will be targeted for enrollment from a consecutive cohort of men who are referred to the University of Miami for prostate cancer evaluation and management, which includes internal and external physician referrals, most often due to an increased PSA, and/or abnormal digital rectal exam (DRE).
Who may be able to join
- Male participant, aged 40-85 years.
- In good general health as evidenced by medical history.
- Referred for a biopsy of the prostate for evaluation of prostate cancer due to elevated or increasing prostate-specific antigen (PSA) or an abnormal digital rectal exam (DRE).
- Participant must agree to forego testosterone supplementation during the duration of the study due to unknown impacts on prostate cancer biomarkers.
Who cannot join
- Previous or current history of prostate cancer or treatment for prostate cancer.
- Previous history of pelvic radiation.
- Known allergic reactions to MRI contrast or inability to undergo MRI due to renal toxicity.
- Inability to undergo blood draw or biopsy of the prostate as per protocol.
- Prior MRI guided biopsy of the prostate for prostate cancer evaluation.
- Previous prostate biopsy or prostate procedure within 6 months of enrollment within the trial.
- Standard contraindications to MRI, such as allergies to contrast die, renal toxicity, ferromagnetic metal in body/eye, pacemaker, defibrillator, other mechanical device, or extreme claustrophobia (medication with anti-anxiety agents, such as Ativan, may be attempted) will prevent eligibility and will be applied for all protocol-related MRIs.
- Patients with impaired decision-making capacity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Marker Driven Selection of Patients for Prostate Biopsy and Management: The University of Miami MDSelect Protocol
The purpose of this research study is to determine if the interpretation of multiparametric MRI (mpMRI) with an algorithm called habitat risk score (HRS) in combination with a panel of blood and urine biomarkers is more effective at detecting prostate cancer than standard of care interpretation of mpMRI with the Prostate Imaging Reporting and Data System (PIRADS).
- Conditions
- PSA, Elevated PSA, Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| GG2+ Prostate Cancer Risk | Participants at risk for Grade Group 2 (GG2+) prostate cancer. Participants will be followed for up to two years to rule out the presence of GG2+ prostate cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative Predictive Value (NPV) for ruling out GG2+ prostate cancer via Habitat Risk Score (HRS) MRI Interpretation software combined with a panel of blood and urine biomarkers, versus via standard of care (SoC) MRI interpretation with PIRADS v2.
The investigators will assess whether automated quantitative HRS MRI interpretation software combined with a panel of blood and urine biomarkers incrementally improves the negative predictive value for ruling out GG2+ cancer on prostate biopsy by 30% or more above standard of care (SoC) MRI interpretation with PIRADS v2.
Measured: Up to 24 months
Secondary outcomes (3)
NPV for ruling out GG2+ prostate cancer via HRS MRI Interpretation software versus via SoC MRI interpretation with PIRADS v2
The investigators will assess whether automated quantitative HRS MRI interpretation software can incrementally improve the negative predictive value (NPV) for ruling out GG2+ cancer on prostate biopsy by 20% or more above SoC MRI interpretation with PIRADS v2.
Measured: Up to 24 months
NPV for ruling out GG2+ prostate cancer by a panel of blood and urine biomarkers versus via SoC MRI interpretation with PIRADS v2
The investigators will assess whether a panel of blood and urine biomarkers can incrementally improve the negative predictive value (NPV) for ruling out GG2+ cancer on prostate biopsy by 10% or more above SoC MRI interpretation with PIRADS v2.
Measured: Up to 24 months
NPV for ruling out clinically significant prostate cancer via HRS MRI interpretation software combined with a panel of blood and urine biomarkers versus via SoC MRI interpretation with PIRADS v2
The investigators will assess whether automated quantitative HRS MRI interpretation software combined with a panel of blood and urine biomarkers incrementally improves the negative predictive value for ruling out clinically significant prostate cancer (defined as any GG2+ cancer OR 50% or more cores of GG1 cancer) on prostate biopsy by 30% or more above standard of care MRI interpretation with PIRADS v2
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start29 Jun 2020
- Primary completion1 Jun 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.
- Other trials for PSAStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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
- 289 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Sanoj Punnen, MD, MAS, University of Miami
- Investigators
- Sanoj Punnen, MD, MAS, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04240327
- Sponsor's protocol ID
- 20190864
- Other IDs
- U01CA239141-01A1, NCI-2020-05157
- Acronym
- MDSelect
- Status last verified
- Jun 2026
- First submitted
- 20 Jan 2020
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Marker Driven Selection of Patients for Prostate Biopsy and Management: The University of Miami MDSelect Protocol
- ClinicalTrials.gov ID
- NCT04240327
- Acronym / sponsor ID
- MDSelect / 20190864
- Conditions
- PSA, Elevated PSA, Prostate Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 289 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 29 Jun 2020 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 27 Jan 2020 (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 this research study is to determine if the interpretation of multiparametric MRI (mpMRI) with an algorithm called habitat risk score (HRS) in combination with a panel of blood and urine biomarkers is more effective at detecting prostate cancer than standard of care interpretation of mpMRI with the Prostate Imaging Reporting and Data System (PIRADS).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GG2+ Prostate Cancer Risk | – | –Participants at risk for Grade Group 2 (GG2+) prostate cancer. Participants will be followed for up to two years to rule out the presence of GG2+ prostate cancer |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants will be targeted for enrollment from a consecutive cohort of men who are referred to the University of Miami for prostate cancer evaluation and management, which includes internal and external physician referrals, most often due to an increased PSA, and/or abnormal digital rectal exam (DRE).
Key inclusion criteria (4 listed)
- Male participant, aged 40-85 years.
- In good general health as evidenced by medical history.
- Referred for a biopsy of the prostate for evaluation of prostate cancer due to elevated or increasing prostate-specific antigen (PSA) or an abnormal digital rectal exam (DRE).
- Participant must agree to forego testosterone supplementation during the duration of the study due to unknown impacts on prostate cancer biomarkers.
Key exclusion criteria (8 listed)
- Previous or current history of prostate cancer or treatment for prostate cancer.
- Previous history of pelvic radiation.
- Known allergic reactions to MRI contrast or inability to undergo MRI due to renal toxicity.
- Inability to undergo blood draw or biopsy of the prostate as per protocol.
- Prior MRI guided biopsy of the prostate for prostate cancer evaluation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Negative Predictive Value (NPV) for ruling out GG2+ prostate cancer via Habitat Risk Score (HRS) MRI Interpretation software combined with a panel of blood and urine biomarkers, versus via standard of care (SoC) MRI interpretation with PIRADS v2.
Time frame: Up to 24 months
The investigators will assess whether automated quantitative HRS MRI interpretation software combined with a panel of blood and urine biomarkers incrementally improves the negative predictive value for ruling out GG2+ cancer on prostate biopsy by 30% or more above standard of care (SoC) MRI interpretation with PIRADS v2.
3 secondary outcomes
NPV for ruling out GG2+ prostate cancer via HRS MRI Interpretation software versus via SoC MRI interpretation with PIRADS v2
Time frame: Up to 24 months
NPV for ruling out GG2+ prostate cancer by a panel of blood and urine biomarkers versus via SoC MRI interpretation with PIRADS v2
Time frame: Up to 24 months
NPV for ruling out clinically significant prostate cancer via HRS MRI interpretation software combined with a panel of blood and urine biomarkers versus via SoC MRI interpretation with PIRADS v2
Time frame: Up to 24 months
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 12 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Sanoj Punnen, MD, MAS principal investigator
University of Miami
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 PSA and Elevated PSA, run by University of Miami 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 8 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: under way, not looking for participants, as of the sponsor's last update on 12 Jun 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?
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?
Negative Predictive Value (NPV) for ruling out GG2+ prostate cancer via Habitat Risk Score (HRS) MRI Interpretation software combined with a panel of blood and urine biomarkers, versus via standard of care (SoC) MRI interpretation with PIRADS v2. (time frame: Up to 24 months). 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 12 Jun 2026.