Utilization of Flotufolastat 18F PET for Post-Focal Therapy Prostate Cancer Evaluation
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of California, Irvine
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Flotufolastat F18 PET
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
University of California, Irvine
Lead sponsor
Blue Earth Diagnostics
Collaborator
Source ClinicalTrials.gov