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

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
University of Florida
Study ID
NCT07220720
Phase
PHASE2
Status
Recruiting
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Conditions

  • Prostate

Eligibility Criteria

Sex
MALE
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Nov 4, 2025
Status verified
Feb 2026
Primary completion
Jul 15, 2030
Completion
Nov 15, 2032

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: POSLUMA PET scan
    Eligible participants will undergo a PSMA PET scan after infusion of POSLUMA imaging agent.

Primary Outcome Measure

Change in positive predictive value (PPV) [ Time Frame: From enrollment to the end of treatment visit at roughly 12 weeks. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UF Health - JacksonvilleJacksonvilleFlorida32209
Shelby Sparks
[email protected]
904-244-7340
Kethandapatti Balaji, MD (PRINCIPAL_INVESTIGATOR)

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UF Health - Jacksonville· Jacksonville, FL

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