Prostate CancerPRISMNCT07916311
POSLUMA PET Imaging for PI-RADS 3 Prostate Lesions
A study testing PET Imaging with Flotufolastat F 18 in people with Prostate Cancer and PI-RADS 3 Prostate Lesion, run by SimonMed Imaging at 6 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, PI-RADS 3 Prostate Lesion
- What is being tested?
- PET Imaging with Flotufolastat F 18
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 Dec 2026to Dec 2028
- Phase
- Interventional
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites
SimonMed Imaging - Akos
Avondale, Arizona, 85392
Xiaowei Hong, 86+15821075453, adeline.hong@simonmed.com
SimonMed Imaging - Chandler South
Chandler, Arizona, 85224
Xiaowei Hong, 86+15821075453, adeline.hong@simonmed.com
SimonMed Imaging - Greenfield
Mesa, Arizona, 85206
Xiaowei Hong, 86+15821075453, adeline.hong@simonmed.com
SimonMed Imaging - Central Phoenix
Phoenix, Arizona, 85004
Xiaowei Hong, 86+15821075453, adeline.hong@simonmed.com
SimonMed Imaging - Kierland
Scottsdale, Arizona, 85254
Xiaowei Hong, 86+15821075453, adeline.hong@simonmed.com
SimonMed Imaging - Surprise Stadium Village
Surprise, Arizona, 85374
Xiaowei Hong, 86+15821075453, adeline.hong@simonmed.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Cancer, PI-RADS 3 Prostate Lesion
- Being tested
- PET Imaging with Flotufolastat F 18
- Keywords
- clinically significant prostate cancer, prostate-specific membrane antigen, PSMA PET, flotufolastat F 18, POSLUMA, multiparametric MRI, prostate biopsy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET Imaging with Flotufolastat F 18Diagnostic test
Also called POSLUMA, 18F-rhPSMA-7.3
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.
| Study group | Role | What they receive |
|---|---|---|
| POSLUMA PET Diagnostic Imaging | Experimental | Participants undergo one research-only POSLUMA PET/MRI or PET/CT before targeted and systematic prostate biopsy. Receives: Diagnostic Test: PET Imaging with Flotufolastat F 18 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of POSLUMA PET for clinically significant prostate cancer
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.
Measured: From research PET imaging through histopathology review, up to approximately 6 weeks after the PET scan
Secondary outcomes (7)
Sensitivity of POSLUMA PET
Lesion-level sensitivity for detecting clinically significant prostate cancer using biopsy histopathology as the reference standard.
Measured: From research PET imaging through histopathology review, up to approximately 6 weeks after the PET scan
Specificity of POSLUMA PET
Lesion-level specificity for detecting clinically significant prostate cancer using biopsy histopathology as the reference standard.
Measured: From research PET imaging through histopathology review, up to approximately 6 weeks after the PET scan
Positive predictive value of POSLUMA PET
Positive predictive value for detecting clinically significant prostate cancer using biopsy histopathology as the reference standard.
Measured: From research PET imaging through histopathology review, up to approximately 6 weeks after the PET scan
Negative predictive value of POSLUMA PET
Negative predictive value for detecting clinically significant prostate cancer using biopsy histopathology as the reference standard.
Measured: From research PET imaging through histopathology review, up to approximately 6 weeks after the PET scan
Potential biopsy avoidance rate
Percentage of participants with low PSMA uptake who would be classified as potentially able to avoid biopsy under the study's exploratory imaging criteria.
Measured: At completion of biopsy histopathology review, up to approximately 6 weeks after the PET scan
Missed clinically significant prostate cancer rate
Proportion of clinically significant prostate cancer cases associated with low PSMA uptake under the study's exploratory imaging criteria.
Measured: At completion of biopsy histopathology review, up to approximately 6 weeks after the PET scan
Performance of a multivariable diagnostic model
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.
Measured: After completion of imaging, biopsy, and histopathology data collection, through December 2028
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start1 Dec 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled participants receive one research-only POSLUMA PET/MRI or PET/CT before clinically indicated prostate biopsy.
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SimonMed Imaging
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Earth Diagnostics
- Responsible party
- Sponsor
- Investigators
- Howard John Simon, MD, Principal investigator, SimonMed Imaging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07916311
- Sponsor's protocol ID
- TUNIRB000379
- Acronym
- PRISM
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07916311
- Acronym / sponsor ID
- PRISM / TUNIRB000379
- Conditions
- Prostate Cancer, PI-RADS 3 Prostate Lesion
- Keywords
- clinically significant prostate cancer, prostate-specific membrane antigen, PSMA PET, flotufolastat F 18, POSLUMA, multiparametric MRI, prostate biopsy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- SimonMed ImagingUniversity, hospital or other
- Collaborators
- Blue Earth Diagnostics
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 4 Nov 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, 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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled participants receive one research-only POSLUMA PET/MRI or PET/CT before clinically indicated prostate biopsy.
| Arm | Type | Receives |
|---|---|---|
| POSLUMA PET Diagnostic Imaging | Experimental | Diagnostic Test: PET Imaging with Flotufolastat F 18Participants undergo one research-only POSLUMA PET/MRI or PET/CT before targeted and systematic prostate biopsy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| PET Imaging with Flotufolastat F 18Also: POSLUMA, 18F-rhPSMA-7.3Participants 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. | Diagnostic test | POSLUMA PET Diagnostic Imaging |
Primary outcome
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.
7 secondary outcomes
Sensitivity of POSLUMA PET
Time frame: 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
Positive 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 of POSLUMA PET
Time frame: 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
Missed clinically significant prostate cancer rate
Time frame: 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
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 4 Nov 2026.
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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.
Howard John Simon, MD principal investigator
SimonMed Imaging
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET Imaging with Flotufolastat F 18 in people with Prostate Cancer and PI-RADS 3 Prostate Lesion, run by SimonMed Imaging at 6 sites 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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 Xiaowei Hong (702-433-6944, adeline.hong@simonmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 4 Nov 2026.