Flotufolastat F 18 PET in Men With Very Low PSA Recurrence

A Prospective Study of Flotufolastat F 18 Positron Emission Tomography in Men With Very Low Prostate Specific Antigen Recurrence

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer (Adenocarcinoma); Prostate Specific Antigen
• Intervention / Treatment: Diagnostic test: Positron Emission Tomography (PET)

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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Jason Efstathiou, MD, DPhil; Phone Number: 617-726-5866; Email: jefstathiou@mgb.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Jason Efstathiou, MD, DPhil; Phone Number: 617-726-5866; Email: jefstathiou@mgb.org
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Dana Farber Cancer Institute
      • Contact: Jonathan Leeman, MD; Phone Number: 617-732-6452; Email: JELEEMAN@BWH.HARVARD.EDU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants will be identified and screened for eligibility via physician referral, clinic visit, or medical record review.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Very Low Prostate Specific Antigen Recurrence; Men >18 years of age will undergo screening to confirm eligibility for this research study. Participants will receive a PET scan with flotufolastat F 18 injection on study visit 2.	Diagnostic test: Positron Emission Tomography (PET); This is a PET scan with flotufolastat F 18 injection.; Other Names: Flotufolastat F 18 PET

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection Rate	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.	Periprocedural to date of detected lesion

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Blue Earth Diagnostics
• Investigators: Principal Investigator: Jason Efstathiou, MD, DPhil, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2025
• Primary Completion (Actual): January 16, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 20, 2025
• First Submitted That Met QC Criteria: March 3, 2025
• First Posted (Actual): March 6, 2025

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: prostate cancer; flotufolastat F 18 positron emission tomography; low prostate specific antigen recurrence
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Prostatic Neoplasms; Adenocarcinoma; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Diagnostic Imaging; Image Interpretation, Computer-Assisted; Image Enhancement; Photography; Tomography, Emission-Computed; Radionuclide Imaging; Diagnostic Techniques, Radioisotope; Positron-Emission Tomography
• Other Study ID Numbers: 24-770

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: Jason Efstathiou, MD, DPhil (efstathiou@mgb.org) at 617-726-5866. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No