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An Investigational Scan (rhPSMA-7.3 PET/CT) for Detecting Biochemically Recurrent Prostate Cancer, ENLIGHTEN Trial

NCT06813898 · Northwestern University
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Official title
ENLIGHTEN: Detection by POSLUMA Following Negative Other PET-PSMA Imaging
About this study
PRIMARY OBJECTIVE: I. Determine consensus detection rate by flotufolastat F-18 gallium (rhPSMA-7.3)-PET (POSLUMA) scan in men with recent negative non-POSLUMA PET prostate specific membrane antigen (PSMA) scans. SECONDARY OBJECTIVES: I. Determine patient level verified detection rates (by histopathology or a surrogate standard of truth \[second contemporaneous imaging, treatment response/change in subsequent imaging\]). II. Determine change in management plan based on POSLUMA scan (major / minor). EXPLORATORY OBJECTIVE: I. Determine patient and patient disease characteristics consistent with a positive POSLUMA scan at prostate specific antigen (PSA) \< 0.5ng/ml (i.e. pathological Gleason grade, PSA at scan, time to biochemical recurrence \[BCR\], prostate-specific antigen doubling time \[PSADT\]). OUTLINE: Patients receive rhPSMA-7.3 intravenously (IV) and undergo PET/CT 60 minutes later on day 1. After completion of study intervention, patients are followed up at 14 days and then every 3 months for 2 years.
Eligibility criteria
Inclusion Criteria: * Men with a history of prostate adenocarcinoma treated with local therapy (including radical prostatectomy or radical prostatectomy and secondary therapy \[i.e. salvage radiation\]) * Men must have biochemical recurrence (defined as PSA \>= 0.1ng/ml) after therapy * PSA \< 0.5ng/ml (within 90 days of enrollment) * Men must have had negative or equivocal PET PSMA based imaging with 90 days of enrollment with an Food and Drug Administration (FDA) approved non-POSLUMA tracer * Non-castrate testosterone (testosterone \[T\] \> 50ng/dL) within 90 days of study entry * Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written informed consent and privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures * Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on the study * Concurrent diseases and malignancies are permitted Exclusion Criteria: * Most recent PSA not between 0.1ng/ml and 0.5ng/ml * Men with non-metastatic castrate resistant prostate cancer (defined as rising PSA and T \< 50ng/dl) * Patients receiving 5-alpha reductase inhibitors, androgen deprivation therapy and androgen receptor antagonists within 3 months of enrollment (men may start these therapies at physician discretion immediately following POSLUMA PET PSMA scan)
Study design
Enrollment target: 27 participants
Allocation: na
Masking: none
Age groups: child, adult, older_adult
Timeline
Starts: 2025-04-11
Estimated completion: 2032-02-01
Last updated: 2026-07-02
Interventions
Procedure: Computed TomographyOther: Electronic Health Record ReviewDrug: Flotufolastat F-18 GalliumProcedure: Positron Emission Tomography
Primary outcomes
  • Consensus detection rate (Up to 2 years)
Sponsor
Northwestern University · other
With: National Cancer Institute (NCI)
Contacts & investigators
ContactSophia Kallas · contact · sophia.kallas@northwestern.edu · 312-694-9001
ContactNikki Hubbard · contact · Nikki.Hubbard@northwestern.edu · 312-694-9001
InvestigatorAshley E Ross · principal_investigator, Northwestern University
All locations (1)
Northwestern UniversityRecruiting
Chicago, Illinois, United States