Actively Recruiting
Flotufolastat F 18 PET in Men With Very Low PSA Recurrence
Led by Massachusetts General Hospital · Updated on 2025-11-13
50
Participants Needed
2
Research Sites
80 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
B
Blue Earth Diagnostics
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to assess detection rate of flotufolastat F 18 positron emission tomography (PET) for low prostate specific antigen (PSA) recurrence of prostate cancer (PC) following radical prostatectomy.
CONDITIONS
Official Title
Flotufolastat F 18 PET in Men With Very Low PSA Recurrence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- History of localized histologically confirmed adenocarcinoma of the prostate and received radical prostatectomy with curative intent
- Measurable disease with non-zero PSA value post-radical prostatectomy concerning for biochemically recurrent or persistent disease, at or below 0.20 ng/mL, obtained within 60 days of PET/CT
- At least 6 weeks have passed since radical prostatectomy
- If previously taking androgen deprivation therapy (ADT), it was discontinued at least 16 weeks before PET
- Clinical flotufolastat F 18 PSMA PET/CT scan prescribed as part of standard care management
- Age 18 years or older
- Prior or concurrent malignancies allowed if they do not interfere with safety or efficacy assessments
- Able to understand and willing to sign informed consent
You will not qualify if you...
- Currently receiving androgen deprivation therapy (ADT) including surgical orchidectomy, LHRH agonists or antagonists, or anti-androgens alone or in combination
- Receiving other investigational agents for this condition within five biological half-lives before flotufolastat F 18 administration
- History of allergic reactions to compounds similar to flotufolastat F 18 or other study agents
- Received x-ray contrast agent less than 24 hours before the flotufolastat F 18 PET
- Received any other PET imaging agent within 24 hours or 10 half-lives before the flotufolastat F 18 PET/CT
- Use of new medications, over-the-counter medicines, or herbal products that may interact with the study agent without counseling
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
J
Jason Efstathiou, MD, DPhil
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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