Actively Recruiting
RhPSMA-7.3(18F)-PET Scan to Detect Prostate Cancer in Patients with Early PSA Recurrence
Led by AdventHealth · Updated on 2024-10-24
30
Participants Needed
1
Research Sites
5 weeks
Total Duration
On this page
Sponsors
A
AdventHealth
Lead Sponsor
B
Blue Earth Diagnostics
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of flotufolastat F-18, known as Posluma, a radioactive agent used with PET imaging, to detect prostate cancer in men who have very low levels of Prostate-Specific Antigen (PSA) after previous radical prostatectomy surgery. This study focuses on early PSA recurrence in prostate cancer patients and aims to assess how well the 18F-rhPSMA-7.3 PET scan detects cancer compared to other methods. Participants will receive a PET scan using 18F-rhPSMA-7.3 (Posluma) to identify prostate cancer recurrence. If the first scan does not detect cancer but PSA levels rise by more than 0.1 ng/ml, the PET scan will be repeated. This study uses a single-arm design where all participants receive the flotufolastat PET scan, which is FDA approved for detecting PSMA-positive prostate cancer lesions in men suspected of having metastasis or recurrence. During the study, participants will undergo PET scans and their results will be compared with biopsy findings, other imaging methods, and treatment responses over a 24-month period. Researchers will monitor adverse events within 24 hours after the scan. The main measure is the cancer detection rate at 24 months. The study is open-label and does not involve masking, and participants will be followed for up to two years to evaluate the scan's effectiveness in detecting early prostate cancer recurrence.
CONDITIONS
Brief Title
PET Scan Study to Detect Prostate Cancer in Patients with Early PSA Recurrence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- History of localized adenocarcinoma of the prostate treated with radical prostatectomy.
- PSA level greater than or equal to 0.1 ng/ml and less than 0.5 ng/ml.
- Male patients aged 18 years or older.
You will not qualify if you...
- Planned use of x-ray contrast agent or other PET radiotracer less than 24 hours before the flotufolastat F-18 PSMA-PET scan.
- Currently receiving Androgen Deprivation Therapy (ADT).
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.
1 visit (in-person)
Duration - Up to 24 months
Participants undergo PET scans using 18F-rhPSMA-7.3 (Posluma) to detect early recurrence of prostate cancer based on rising PSA levels.
1 initial scan visit and additional scan visits if PSA rises by more than 0.1 ng/ml
Trial Site Locations
Total: 1 location
1
AdventHealth
Orlando, Florida, United States, 32804
Actively Recruiting
Research Team
A
AdventHealth AdventHealth Oncology Research
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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