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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT06813898
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Biochemically Recurrent Prostate Carcinoma
  • Prostate Adenocarcinoma

Eligibility Criteria

Sex
MALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Computed Tomography — PROCEDURE
    Undergo PET/CT
  • Electronic Health Record Review — OTHER
    Ancillary studies
  • Flotufolastat F-18 Gallium — OTHER
    Given IV
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT

Study Details

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.

Key Dates

Start date
Feb 17, 2025
Status verified
Feb 2025
Primary completion
Feb 1, 2027
Completion
Feb 1, 2032

Study Design

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

Arms

  • Experimental: Diagnostic (rhPSMA-7.3 PET/CT)
    Patients receive rhPSMA 7.3 IV and undergo PET/CT 60 minutes later on day 1.

Primary Outcome Measure

Consensus detection rate [ Time Frame: Up to 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611
Ashley E. Ross
[email protected]
312-694-9001
Ashley E. Ross (PRINCIPAL_INVESTIGATOR)

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By research site
Northwestern University· Chicago, IL

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