Clinical trial NCT06862856: Flotufolastat F 18 PET in Men with Very Low PSA Recurrence
Official title: A Prospective Study of Flotufolastat F 18 Positron Emission Tomography in Men with Very Low Prostate Specific Antigen Recurrence
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Prostate Cancer (Adenocarcinoma)
Prostate Specific Antigen
Keywords: flotufolastat F 18 positron emission tomography
low prostate specific antigen recurrence
prostate cancer
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Blue Earth Diagnostics
First posted: 2025-03-06
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be identified and screened for eligibility via physician referral, clinic visit, or medical record review.

Brief summary: 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.

Detailed description: This is a prospective single arm study for the use of flotufolastat F 18 PET in men with very low prostate specific antigen recurrence. The research study involves collecting flotufolastat F 18 PET images to evaluate the detection rate. Flotufolastat F 18 is a radiopharmaceutical (radioactive agent) the U.S. Food and Drug Administration (FDA) has approved. Participation in this study will be for the duration of the flotufolastat F 18 PET scan. It is expected that about 50 people will take part in this research study.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Detection Rate
timeFrame: Periprocedural to date of detected lesion
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Jason Efstathiou, MD, DPhil
role: PRINCIPAL_INVESTIGATOR
References: