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
4 other identifiers
interventional
27
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1
Started Feb 2025
Longer than P75 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2025
CompletedFirst Posted
Study publicly available on registry
February 7, 2025
CompletedStudy Start
First participant enrolled
February 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2032
February 18, 2025
February 1, 2025
2 years
February 3, 2025
February 17, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Consensus detection rate
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.
Up to 2 years
Secondary Outcomes (2)
Patient level verified detection rates
Up to 2 years
Change in management plan based on POSLUMA scan
Up to 2 years
Study Arms (1)
Diagnostic (rhPSMA-7.3 PET/CT)
EXPERIMENTALPatients receive rhPSMA 7.3 IV and undergo PET/CT 60 minutes later on day 1.
Interventions
Undergo PET/CT
Given IV
Undergo PET/CT
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northwestern Universitylead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Northwestern University
Chicago, Illinois, 60611, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ashley E Ross
Northwestern University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Masking Details
- Reads will be completed by three trained radiologists blinded to each other's reads.
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2025
First Posted
February 7, 2025
Study Start
February 17, 2025
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
February 1, 2032
Last Updated
February 18, 2025
Record last verified: 2025-02