Actively Recruiting

Early Phase 1
MALE
NCT06813898

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

Led by Northwestern University · Updated on 2025-02-18

27

Participants Needed

1

Research Sites

362 weeks

Total Duration

On this page

Sponsors

N

Northwestern University

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Men with a history of prostate adenocarcinoma treated with local therapy (including radical prostatectomy or radical prostatectomy and secondary therapy such as salvage radiation)
  • Men with biochemical recurrence defined as PSA ≥ 0.1 ng/ml after therapy
  • PSA less than 0.5 ng/ml within 90 days of enrollment
  • Negative or equivocal PET PSMA imaging with FDA-approved non-POSLUMA tracer within 90 days of enrollment
  • Non-castrate testosterone level greater than 50 ng/dL within 90 days of study entry
  • Written informed consent obtained according to regulations
  • Ability and willingness to sign informed consent prior to registration
  • Concurrent diseases and malignancies are allowed
Not Eligible

You will not qualify if you...

  • Most recent PSA not between 0.1 ng/ml and 0.5 ng/ml
  • Non-metastatic castrate resistant prostate cancer (rising PSA and testosterone less than 50 ng/dL)
  • Receiving 5-alpha reductase inhibitors, androgen deprivation therapy, or androgen receptor antagonists within 3 months of enrollment (except after POSLUMA scan at physician discretion)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Northwestern University

Chicago, Illinois, United States, 60611

Actively Recruiting

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Research Team

S

Sophia Kallas

CONTACT

N

Nikki Hubbard

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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