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Flotufolastat F 18 PET for Low PSA Recurrence in Prostate Cancer

This study is looking at how well a special type of scan, called flotufolastat F 18 PET (Positron Emission Tomography), can find prostate cancer that has come back after surgery, even when the PSA (Prostate Specific Antigen) levels are very low. You might be able to join if you are a man who has had surgery for prostate cancer and now have a low, but detectable, PSA level. The main goal is to see how often this scan can detect the cancer. About 50 people are expected to participate, but the current recruitment status is unclear.

Study design
This is a single-arm study, meaning all participants receive the same intervention. Approximately 50 men are expected to participate.
What's involved
Participation in this study will involve undergoing a flotufolastat F 18 PET scan.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, detection rate, is measured from the periprocedural period to the date a lesion is detected.

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NCT06862856

Flotufolastat F 18 PET in Men With Very Low PSA Recurrence

Recruiting
Not specifiedAges 18+Observational
Massachusetts General Hospital
~50 participants
Updated 2026-05-15 on ClinicalTrials.gov
What's tested:Positron Emission Tomography (PET)

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Detection Rate
Measured over Periprocedural to date of detected lesion

Conditions

Prostate Cancer (Adenocarcinoma)
Prostate Specific Antigen

Explore related trials

Prostate Carcinoma

Where it's being run

2 sites across 1 states
Massachusetts2

Study leadership

  • Jason Efstathiou, MD, DPhil · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

Jason Efstathiou, MD, DPhil
[email protected]
617-726-5866
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participants must have a history of localized histologically confirmed adenocarcinoma of the prostate and have received radical prostatectomy (RP) with curative intent.
Participants must have measurable disease, defined as a non-zero PSA value post-RP that is concerning for biochemically recurrent or persistent disease, is ≤0.20 ng/mL, and obtained within 60 days of PET/CT.
At least 6 weeks must have elapsed after RP. If previously taking ADT, it should have been discontinued at least 16 weeks prior to PET.
Participants with a clinical flotufolastat F 18 PSMA PET/CT scan prescribed as part of the standard of care management.
Age ≥18 years.
Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
Ability to understand and the willingness to sign a written informed consent document.

Exclusion

Participants currently receiving ADT (defined as surgical orchidectomy; luteinizing hormone-releasing hormone \[LHRH\] agonist alone \[continuous or intermittent\]; LHRH antagonist alone \[continuous or intermittent\]; administration or use of a first or second generation anti-androgen alone or in combination with an LHRH agonist/antagonist).
Participants who are receiving any other investigational agents for this condition within five biological half-lives prior to administration of flotufolastat F 18.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to flotufolastat F 18 or other agents used in study.
Participants receiving any of the following substances will be considered ineligible: x-ray contrast agent \<24 hours prior to the flotufolastat F 18 PET and any other PET imaging agent within 24 hours or 10 half-lives, whichever is longer, prior to the flotufolastat F 18 PET/CT. As part of the enrollment/informed consent procedures, the participant will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product.

What this trial measures

  • Detection RatePeriprocedural to date of detected lesion

    The detection rate is defined as the percentage of all patients scanned who have at least one positive lesion (localized correspondence between flotufolastat F 18 PET/CT imaging and the reference standard) regardless of coexisting false positive findings.