Recruiting

Flotufolastat F 18

Sponsor:

Massachusetts General Hospital

Code:

NCT06862856

Conditions

Prostate Cancer (Adenocarcinoma)

Prostate Specific Antigen

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Positron Emission Tomography (PET)

Study Details

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

Study ID

NCT06862856

Start date

May 20, 2025

Status verified date

May, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Jan 16, 2026

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Positron Emission Tomography (PET)

This is a PET scan with flotufolastat F 18 injection.

Primary outcome measure

  • Detection Rate [ Time Frame: Periprocedural to date of detected lesion ]

Central Contacts and Locations

Central contacts

Jason Efstathiou, MD, DPhil

617-726-5866jefstathiou@mgb.org

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Jason Efstathiou, MD, DPhil

617-726-5866jefstathiou@mgb.org

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Jonathan Leeman, MD

617-732-6452JELEEMAN@BWH.HARVARD.EDU

More Information

Sponsor

Massachusetts General Hospital

Last update posted

May 15, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-05-15.