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NCT Number: NCT07220720

POSLUMA® (18F-rhPSMA-7.3) PET-CT for PIRADS 2/3 Lesions

The goal of this study to determine if using the (18)F-rhPSMA-7.3 PET-CT scan can improve the ability to spot serious prostate cancer in patients who have uncertain MRI results. These uncertain results include MRI results that showed a PIRADS 2 or PIRADS 3 area on the prostate. The investigators want to find out if this new test is better to detect prostate cancer than just doing a biopsy based on MRI alone.

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Key information

Conditions

Prostate Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–100 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

UF Health - Jacksonville

Jacksonville, Florida, 32209, United States

Location status: Recruiting

Location contact

Kethandapatti Balaji, MD

PRINCIPAL_INVESTIGATOR

Shelby Sparks

CONTACT

[email protected]

904-244-7340

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patient is willing to provide signed informed consent and is able to comply with all required study-related procedures, where safe and feasible.
  • The patient is male and at least 18 years of age.
  • The patient has not previously undergone a prostate biopsy.
  • The patient underwent a pelvic mpMRI within the last 90 days for the detection of potential prostate cancer (Pca).
  • The patient is a candidate for a targeted MRI/US biopsy and is scheduled to undergo the procedure. Only patients scheduled for a biopsy before recruitment will be considered candidates.
  • The patient has PIRADS 2 and/or PIRADS 3 lesions detected by a board-certified radiologist.

Exclusion criteria

  • Patients with a prior diagnosis of prostate cancer.
  • Patients with any medical condition or circumstance that, in the investigator's opinion, could compromise the study data or prevent the patient from fulfilling the study requirements.
  • Patients participating in another interventional clinical trial within the past 30 days.
  • Patients with known hypersensitivity to the active substance or any excipients of flotufolastat F 18 PET-CT.

Treatment and study plan

Flotufolastat F 18

Drug

A PSMA-targeted PET imaging agent used to detect and locate prostate cancer during PET scans that will be administered one time to each study subject.

Other names: (18)F-rhPSMA-7.3, POSLUMA

Primary outcomes

  1. Change in positive predictive value (PPV)

    Time frame: From enrollment to the end of treatment visit at roughly 12 weeks.

    Evaluate the change in PPV for detecting clinically significant prostate cancer (csPCa) cores by comparing results from mpMRI alone (PIRADS 2 and 3 lesions) to the combination of mpMRI with flotufolastat F 18 PET-CT.

  2. Change in negative predictive value (NPV)

    Time frame: From enrollment to the end of treatment visit at roughly 12 weeks.

    Measure the change in NPV for detecting csPCa cores by comparing mpMRI findings alone (PIRADS 2 and 3 lesions) with the combined approach of mpMRI and flotufolastat F 18 PET-CT.

  3. Improvement in Accuracy

    Time frame: From enrollment to the end of treatment visit at roughly 12 weeks

    Assess the improvement in accuracy (accuracy defined as [(true positive + true negative) / total number of subjects] when using the combined imaging approach of flotufolastat F 18 PET-CT with mpMRI versus mpMRI alone in patients with PIRADS 2 and 3 lesions.

Study contacts

Contact information is provided by the study sponsor or research team.

Shelby Sparks

CONTACT

[email protected]

904-244-7340

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

Inclusion of POSLUMA® ((18)F-rhPSMA-7.3) PET-CT Imaging Improves Diagnostic Accuracy of Clinically-Significant Prostate Cancer Diagnosis in Men With PIRADS 2 and 3 Lesions on MRI

Important dates

Study start
2025
Primary completion
2030
Study completion
2032
First posted
Oct 24, 2025
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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