TheranosticTrials.org

Clinical Trial · NCT06862856

Flotufolastat F 18 PET in Men With Very Low PSA Recurrence

Overview

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.

Sponsor

Massachusetts General Hospital

Contacts

Jason Efstathiou, MD, DPhil (CONTACT)

jefstathiou@mgb.org

617-726-5866

Jason Efstathiou, MD, DPhil (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT06862856

Drug / Compound

flotufolastat

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: DOTAGA

Eligibility

Inclusion

  • 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.
  • Participants must have a history of localized histologically confirmed adenocarcinoma of the prostate and have received radical prostatectomy (RP) with curative intent.
  • 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.

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).