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ENLIGHTEN Trial: Investigating rhPSMA-7.3 PET/CT for Recurrent Prostate Cancer

This study, called the ENLIGHTEN Trial, is looking at a new imaging technique using rhPSMA-7.3 PET/CT (also known as POSLUMA) to find prostate cancer in men whose prostate-specific antigen (PSA) levels are rising again after previous treatment. This is for men who had a negative PET scan recently. The rhPSMA-7.3 (flotufolastat F-18 gallium) is a special contrast agent given through an IV that helps highlight cancer cells on the PET/CT scan. The main goal is to see how well this scan can detect the cancer. The study is for men who have had prostate cancer treated, but now have a biochemical recurrence (PSA at or above 0.1 ng/ml). The study plans to enroll 27 men.

Study design
This is an interventional study, meaning participants will receive a specific intervention. It is designed to evaluate the detection rate of the rhPSMA-7.3 PET/CT scan in men with recurrent prostate cancer.
What's involved
You would receive rhPSMA-7.3 intravenously and undergo a PET/CT scan 60 minutes later on one day. You would then have follow-up appointments at 14 days and every 3 months for up to 2 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed up at 14 days and then every 3 months for 2 years after the study intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06813898

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

Recruiting
EARLY_PHASE1All AgesInterventionalDiagnostic
Northwestern University
~27 participants
Updated 2026-07-02 on ClinicalTrials.gov
What's tested:Computed TomographyElectronic Health Record ReviewFlotufolastat F-18 GalliumPositron Emission Tomography

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Consensus detection rate
Measured over Up to 2 years

Conditions

Biochemically Recurrent Prostate Carcinoma
Prostate Adenocarcinoma

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Where it's being run

1 sites across 1 states
Illinois1

Study leadership

  • Ashley E Ross · PRINCIPAL_INVESTIGATOR · Northwestern University

Who to contact

Sophia Kallas
[email protected]
312-694-9001
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Consensus detection rateUp to 2 years

    Reads will be completed for the positron emission tomography (PET)/computed tomography (CT) by three trained radiologist blinded to each other's read. Uptake values of rhPSMA-7.3 (POSLUMA) in the prostate bed and other sites (i.e. lymph nodes or bones) will be evaluated. Location and avidity (standardized uptake value) of all identified PET positive sites will be recorded (series/slice number). Consensus read will be determined as positive or negative at the patient level as the consensus of at least 2 of the 3 reading radiologists. Detection rates will be presented with 95% confidence intervals.