Clinical Trial · NCT07568756

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

Overview

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

ClinicalTrials.gov

NCT07568756

Drug / Compound

Flotufolastat F18

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Eligibility

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