RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-02-17
Study Completion:2032-02-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06813898

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men with a history of prostate adenocarcinoma treated with local therapy (including radical prostatectomy or radical prostatectomy and secondary therapy \[i.e. salvage radiation\])
  2. * Men must have biochemical recurrence (defined as PSA \>= 0.1ng/ml) after therapy
  3. * PSA \< 0.5ng/ml (within 90 days of enrollment)
  4. * 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
  5. * Non-castrate testosterone (testosterone \[T\] \> 50ng/dL) within 90 days of study entry
  6. * 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
  7. * Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on the study
  8. * Concurrent diseases and malignancies are permitted
  1. * Most recent PSA not between 0.1ng/ml and 0.5ng/ml
  2. * Men with non-metastatic castrate resistant prostate cancer (defined as rising PSA and T \< 50ng/dl)
  3. * 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)

Contacts and Locations

Study Contact

Sophia Kallas
CONTACT
312-694-9001
sophia.kallas@northwestern.edu
Nikki Hubbard
CONTACT
312-694-9001
Nikki.Hubbard@northwestern.edu

Principal Investigator

Ashley E Ross
PRINCIPAL_INVESTIGATOR
Northwestern University

Study Locations (Sites)

Northwestern University
Chicago, Illinois, 60611
United States

Collaborators and Investigators

Sponsor: Northwestern University

  • Ashley E Ross, PRINCIPAL_INVESTIGATOR, Northwestern University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-17
Study Completion Date2032-02-01

Study Record Updates

Study Start Date2025-02-17
Study Completion Date2032-02-01

Terms related to this study

Additional Relevant MeSH Terms

  • Biochemically Recurrent Prostate Carcinoma
  • Prostate Adenocarcinoma