Utilization of Flotufolastat 18F PET for Post-Focal Therapy Prostate Cancer Evaluation

Description:

This is a phase II single arm, open-label clinical trial determining diagnostic accuracy of Flotufolastat F18 PET in subjects with prostate adenocarcinoma. These are subjects who have not previously received treatment for prostate cancer.

Sponsor:

University of California, Davis

Phase:

Phase 2

Contacts:

University of California Irvine Medical Center (CONTACT)

Michael Daneshvar, MD (PRINCIPAL_INVESTIGATOR)

Chao Family Comprehensive Cancer Center University of California, Irvine (CONTACT)

ucstudy@uci.edu

1-877-827-8839

Flotufolastat F18

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Inclusion
  • * Age 18 years or greater at time of consent
  • Prostate Cancer planned to be treated by focal therapy (e.g. cryotherapy, HIFU, or NanoKnife)
  • Planned pre- and post- treatment MRI-fusion biopsy
  • Multiparametric-MRI imaging planned
  • Prostate adenocarcinoma (no other histologic subtypes allowed)
Exclusion
  • High-risk prostate cancer (diagnosed by biopsy)
  • * Prior treatment for any prostate malignancy (e.g. radiation, focal therapy, or systemic therapy)
  • Bilateral prostatic lobe disease
  • PSA \>10
  • Genomic classifiers (e.g. Decipher) signifying intermediate or high-risk disease