Utilization of Flotufolastat 18F PET for Post-Focal Therapy Prostate Cancer Evaluation
2 other identifiers
interventional
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2026
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2026
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedFirst Posted
Study publicly available on registry
May 6, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2029
May 6, 2026
April 1, 2026
2 years
April 28, 2026
April 28, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Flotufolastat F18 PET findings
Compare Flotufolastat F18 PET findings to mpMRI and MRI-fusion biopsy results to determine successful treatment by focal therapy.
5 years
Secondary Outcomes (3)
Changes in Circulating Tumor Deoxyribonucleic acid (ctDNA) levels
5 years
Changes in PSA levels
5 years
Change in genomic assay scores
5 years
Study Arms (1)
Post-Focal Therapy Flotufolastat F18PET
EXPERIMENTALPost-Focal Therapy Flotufolastat F18 PET
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, Irvinelead
- Blue Earth Diagnosticscollaborator
Study Sites (1)
Chao Family Comprehensive Cancer Center, University of California, Irvine
Orange, California, 92868, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Daneshvar, MD
Chao Family Comprehensive Cancer Center
Central Study Contacts
Chao Family Comprehensive Cancer Center University of California, Irvine
CONTACT
University of California Irvine Medical Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Clinical Urology
Study Record Dates
First Submitted
April 28, 2026
First Posted
May 6, 2026
Study Start
May 1, 2026
Primary Completion (Estimated)
May 1, 2028
Study Completion (Estimated)
May 1, 2029
Last Updated
May 6, 2026
Record last verified: 2026-04