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

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

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.

Inclusion Criteria:

• Age 18 years or greater at time of consent
• Prostate adenocarcinoma (no other histologic subtypes allowed)
• Prostate Cancer planned to be treated by focal therapy (e.g. cryotherapy, HIFU, or NanoKnife)
• Multiparametric-MRI imaging planned
• Planned pre- and post- treatment MRI-fusion biopsy

Exclusion Criteria:

• Prior treatment for any prostate malignancy (e.g. radiation, focal therapy, or systemic therapy)
• Genomic classifiers (e.g. Decipher) signifying intermediate or high-risk disease
• PSA >10
• High-risk prostate cancer (diagnosed by biopsy)
• Bilateral prostatic lobe disease