RecruitingEarly Phase 1NCT06813898

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

ENLIGHTEN: Detection by POSLUMA Following Negative Other PET-PSMA Imaging


Sponsor

Northwestern University

Enrollment

27 participants

Start Date

Feb 17, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial evaluates an imaging technique (rhPSMA-7.3 positron emission tomography \[PET\]/computed tomography \[CT\]) for detecting prostate cancer in patients who have increasing prostate-specific antigen levels following prior treatment (biochemical recurrence) but who were prostate specific membrane antigen negative on their most recent PET scan. Contrast agents like rhPSMA-7.3 (also called POSLUMA) circulate in the blood until they find their intended target. Once they are taken up by the target tumor cells, they can be visualized using PET/CT cameras. A PET scan is a procedure in which a small amount of radioactive tracer (in this case rhPSMA-7.3) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the tracer is taken up. Because tumor cells often take up more tracer than normal cells, the pictures can be used to find tumor cells in the body. A CT scan is a procedure that uses a computer linked to an x-ray machine to make a series of detailed pictures of areas inside the body. The pictures are taken from different angles and are used to create 3-dimensional views of tissues and organs. Combining a PET scan with a CT scan can help make the image easier to interpret. PET/CT scans are hybrid scanners that combine both modalities into a single scan during the same examination. The researchers want to determine whether the rhPSMA7.3 PET/CT scan is useful for detecting biochemically recurrent prostate cancer in patients who were negative on prior non-POSLUMA PET imaging.


Eligibility

Sex: MALE

Plain Language Summary

Simplified for easier understanding

This study, called the ENLIGHTEN Trial, is testing a new type of PET scan using a radioactive tracer called rhPSMA-7.3 to find prostate cancer that has come back after surgery or radiation treatment. The scan targets a protein found on prostate cancer cells. It is being studied in men whose PSA blood level has risen again (a sign the cancer may be returning) but is still very low — a situation where other scans often cannot detect anything. **You may be eligible if...** - You are a man who had prostate cancer treated with surgery (radical prostatectomy) and possibly follow-up radiation - Your PSA level has risen above 0.1 ng/mL but is below 0.5 ng/mL - A recent FDA-approved PSMA PET scan (other than POSLUMA) was negative or unclear - Your testosterone level is in the normal range **You may NOT be eligible if...** - Your PSA is 0.5 ng/mL or higher - You have not had a prior PSMA PET scan with an FDA-approved tracer - Your testosterone is suppressed (below 50 ng/dL) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREComputed Tomography

Undergo PET/CT

OTHERElectronic Health Record Review

Ancillary studies

OTHERFlotufolastat F-18 Gallium

Given IV

PROCEDUREPositron Emission Tomography

Undergo PET/CT


Locations(1)

Northwestern University

Chicago, Illinois, United States

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NCT06813898


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