POSLUMA PET Imaging for PI-RADS 3 Prostate Lesions (PRISM)

October 29, 2026 updated by: SimonMed Imaging

Targeting the Gray Zone: Early Detection of Clinically Significant Prostate Cancer in PI-RADS 3 Patients Using PET Imaging With an 18F-Labeled Radiohybrid PSMA-Targeted Imaging Agent

This prospective, multicenter diagnostic accuracy study will evaluate whether POSLUMA (flotufolastat F 18) PET/MRI or PET/CT can detect clinically significant prostate cancer, defined as Gleason score 7 or higher, in adult men with PI-RADS 3 lesions on recent multiparametric MRI and a clinical indication for prostate biopsy. Participants will undergo a research-only POSLUMA PET scan before targeted and systematic prostate biopsy. PET imaging metrics and clinical variables will be compared with histopathology. Research PET results will not be used to guide clinical management or replace standard diagnostic procedures.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Men aged 18 years or older with a PI-RADS 3 lesion identified on multiparametric MRI within the prior 4 weeks and a clinical indication for prostate biopsy will be consecutively enrolled. After written informed consent, participants will undergo POSLUMA PET/MRI or PET/CT. POSLUMA will be administered as an intravenous bolus at 296 MBq (8 mCi), and imaging will begin approximately 60 minutes after administration. PET-derived metrics, including SUVmax, PRIMARY score, lesion-to-background ratio, and lesion volume, will be recorded. MRI features and clinical parameters, including PSA, PSA density, and free-to-total PSA ratio, may also be collected.

The reference standard will be histopathology from targeted biopsy of the PI-RADS 3 lesion together with systematic prostate biopsy. Diagnostic performance will be evaluated using lesion-level area under the receiver operating characteristic curve, sensitivity, specificity, positive predictive value, and negative predictive value. The study will also estimate biopsy avoidance and missed clinically significant prostate cancer rates and explore multivariable models combining PET, MRI, and clinical variables. Participants should not expect direct clinical benefit, and the research PET result will not alter biopsy decisions or other standard care.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Arizona
      • Avondale, Arizona, United States, 85392
      • Chandler, Arizona, United States, 85224
      • Mesa, Arizona, United States, 85206
      • Phoenix, Arizona, United States, 85004
      • Scottsdale, Arizona, United States, 85254
      • Surprise, Arizona, United States, 85374
        • SimonMed Imaging - Surprise Stadium Village
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male, age 18 years or older
  • PI-RADS 3 lesion diagnosed by multiparametric MRI within the past 4 weeks
  • Clinical indication for prostate biopsy
  • Undergoing targeted biopsy and systematic biopsy as part of the routine clinical pathway
  • Able to provide written informed consent

Exclusion Criteria:

  • Prior diagnosis or treatment of prostate cancer
  • PI-RADS 4 or 5 lesion
  • Negative MRI, defined as PI-RADS 1 or 2
  • Contraindication to PSMA PET or prostate biopsy
  • Contraindication to both MRI and CT
  • Any medical condition that may interfere with study procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: POSLUMA PET Diagnostic Imaging

Participants undergo one research-only POSLUMA PET/MRI or PET/CT before targeted and systematic prostate biopsy.
Diagnostic test: PET Imaging with Flotufolastat F 18

Participants undergo research-only PSMA PET/MRI or PET/CT using POSLUMA (flotufolastat F 18) before clinically indicated prostate biopsy. POSLUMA is administered intravenously at 296 MBq (8 mCi), with PET imaging beginning approximately 60 minutes after administration. PET imaging findings are compared with histopathology from targeted and systematic prostate biopsy.

Other Names:
  • 18F-rhPSMA-7.3
  • POSLUMA

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of POSLUMA PET for clinically significant prostate cancer
Time Frame: From research PET imaging through histopathology review, up to approximately 6 weeks after the PET scan

Lesion-level area under the receiver operating characteristic curve for POSLUMA PET metrics, including SUVmax and PRIMARY score, using biopsy histopathology and clinically significant prostate cancer defined as Gleason score 7 or higher as the reference standard.
From research PET imaging through histopathology review, up to approximately 6 weeks after the PET scan

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sensitivity of POSLUMA PET
Time Frame: From research PET imaging through histopathology review, up to approximately 6 weeks after the PET scan

Lesion-level sensitivity for detecting clinically significant prostate cancer using biopsy histopathology as the reference standard.
From research PET imaging through histopathology review, up to approximately 6 weeks after the PET scan
Specificity of POSLUMA PET
Time Frame: From research PET imaging through histopathology review, up to approximately 6 weeks after the PET scan

Lesion-level specificity for detecting clinically significant prostate cancer using biopsy histopathology as the reference standard.
From research PET imaging through histopathology review, up to approximately 6 weeks after the PET scan
Positive predictive value of POSLUMA PET
Time Frame: From research PET imaging through histopathology review, up to approximately 6 weeks after the PET scan

Positive predictive value for detecting clinically significant prostate cancer using biopsy histopathology as the reference standard.
From research PET imaging through histopathology review, up to approximately 6 weeks after the PET scan
Negative predictive value of POSLUMA PET
Time Frame: From research PET imaging through histopathology review, up to approximately 6 weeks after the PET scan

Negative predictive value for detecting clinically significant prostate cancer using biopsy histopathology as the reference standard.
From research PET imaging through histopathology review, up to approximately 6 weeks after the PET scan
Potential biopsy avoidance rate
Time Frame: At completion of biopsy histopathology review, up to approximately 6 weeks after the PET scan

Percentage of participants with low PSMA uptake who would be classified as potentially able to avoid biopsy under the study's exploratory imaging criteria.
At completion of biopsy histopathology review, up to approximately 6 weeks after the PET scan
Missed clinically significant prostate cancer rate
Time Frame: At completion of biopsy histopathology review, up to approximately 6 weeks after the PET scan

Proportion of clinically significant prostate cancer cases associated with low PSMA uptake under the study's exploratory imaging criteria.
At completion of biopsy histopathology review, up to approximately 6 weeks after the PET scan
Performance of a multivariable diagnostic model
Time Frame: After completion of imaging, biopsy, and histopathology data collection, through December 2028

Model performance when combining PSMA PET metrics with clinical and imaging variables such as PSA, PSA density, free-to-total PSA ratio, ADC, lesion volume, and other protocol-specified variables.
After completion of imaging, biopsy, and histopathology data collection, through December 2028

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
SimonMed Imaging

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Blue Earth Diagnostics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Howard John Simon, MD, SimonMed Imaging

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 29, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TUNIRB000379

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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