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

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.

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)