An interventional study of PET Imaging with Flotufolastat F 18 in Prostate Cancer and PI-RADS 3 Prostate Lesion, sponsored by SimonMed Imaging. Not yet recruiting at 6 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by SimonMed Imaging · Not applicable, Interventional, and Diagnostic
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.
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.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 130 is above the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →This is the only study on the registry with SimonMed Imaging as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Also known as: POSLUMA, 18F-rhPSMA-7.3
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.
Time frame: From research PET imaging through histopathology review, up to approximately 6 weeks after the PET scan
Sensitivity of POSLUMA PET
Lesion-level sensitivity for detecting clinically significant prostate cancer using biopsy histopathology as the reference standard.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: After completion of imaging, biopsy, and histopathology data collection, through December 2028
Start is estimated for Dec 2026; primary completion for Dec 2028, 24 months later.
Of 1,098 non-industry interventional studies with no phase under Prostatic Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 86. This study's planned 24 months is below that.
Counting every sponsor, half of 1,155 studies reached it within 43 months; a quarter within 22 and three quarters within 84.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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