Flotufolastat F 18 PET in Men With Very Low PSA Recurrence

NCT06862856 | Recruiting

• 1 other identifier: 24-770
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Prostate Cancer (Adenocarcinoma); Prostate Specific Antigen

Keywords

flotufolastat F 18 positron emission tomography; low prostate specific antigen recurrence; prostate cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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)

Interventions

Positron Emission Tomography (PET) DIAGNOSTIC_TEST

This is a PET scan with flotufolastat F 18 injection.

Also known as: Flotufolastat F 18 PET

Very Low Prostate Specific Antigen Recurrence

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Men of all races and ethnic groups are eligible for this trial
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Blue Earth Diagnostics: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Adenocarcinoma

Interventions

Positron-Emission Tomography

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Jason Efstathiou, MD, DPhil

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jason Efstathiou, MD, DPhil

CONTACT

617-726-5866; jefstathiou@mgb.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: March 6, 2025
• Study Start: May 20, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 13, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (2)