Actively Recruiting
ENLIGHTEN: Detection by POSLUMA Following Negative Other PET-PSMA Imaging for Biochemically Recurrent Prostate Cancer
Led by Northwestern University ยท Updated on 2025-02-18
27
Participants Needed
1
Research Sites
260 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
Researchers are evaluating a new imaging method called rhPSMA-7.3 PET/CT (also known as POSLUMA) to detect prostate cancer in men whose prostate-specific antigen (PSA) levels are rising after prior treatment but who had negative results on their most recent standard PET scan. This study aims to see how well this new scan finds cancer cells when previous scans did not, helping guide future care decisions. The study is a phase II trial led by Northwestern University. Participants receive an intravenous injection of the rhPSMA-7.3 tracer and then undergo a PET/CT scan 60 minutes later on the first day. This scan combines detailed 3D images from PET and CT to highlight areas where the tracer collects, indicating potential cancer cells. After the scan, patients are followed up at 14 days and then every 3 months for two years to monitor their condition and any changes in their treatment plans. During the study, researchers collect health information and imaging results to measure how often the new scan detects cancer cells (consensus detection rate) and confirm findings with tissue samples or additional imaging. They also track any changes in patient management based on the scan results. Safety and patient outcomes are monitored throughout the two-year follow-up period to assess the usefulness of the rhPSMA-7.3 PET/CT scan in this patient group.
CONDITIONS
Brief Title
An Investigational Scan (rhPSMA-7.3 PET/CT) for Detecting Biochemically Recurrent Prostate Cancer, ENLIGHTEN Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men with a history of prostate adenocarcinoma treated with local therapy such as radical prostatectomy or salvage radiation
- Biochemical recurrence with PSA level of 0.1 ng/ml or higher 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 above 50 ng/dL within 90 days of study entry
- Ability to understand and willingness to sign informed consent
- Concurrent diseases and malignancies are allowed
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 below 50 ng/dL)
- Use of 5-alpha reductase inhibitors, androgen deprivation therapy, or androgen receptor antagonists within 3 months before enrollment (except after the POSLUMA scan as decided by physician)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants receive rhPSMA-7.3 intravenously and undergo a PET/CT scan 60 minutes later on day 1.
1 visit (in-person)
Duration - Up to 2 years
Participants are followed up at 14 days and then every 3 months for 2 years to assess detection rates and changes in management based on the POSLUMA scan.
Follow-up visits at 14 days and every 3 months for 2 years
Trial Site Locations
Total: 1 location
1
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
S
Sophia Kallas
N
Nikki Hubbard
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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