Prostate Adenocarcinoma, Prostate Cancer
Conditions
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.
Interventions
DIAGNOSTIC_TESTFlotufolastat F18 PET
Flotufolastat F18 PET
Sponsors
University of California, Irvine
Blue Earth Diagnostics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Flotufolastat F18 PET findings | 5 years | Compare Flotufolastat F18 PET findings to mpMRI and MRI-fusion biopsy results to determine successful treatment by focal therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Circulating Tumor Deoxyribonucleic acid (ctDNA) levels | 5 years | Changes between timepoints in circulating tumor deoxyribonucleic acid (ctDNA) from baseline (pre-therapy) to the defined post-therapy timepoint. |
| Changes in PSA levels | 5 years | Changes between timepoints in PSA from baseline (pre-therapy) to the defined post-therapy timepoint. |
| Change in genomic assay scores | 5 years | Change in genomic assay scores as measured using each assay's validated soring system from baseline (pre-therapy) to the defined post-therapy timepoint. |
Countries
United States
Contacts
CONTACTChao Family Comprehensive Cancer Center University of California, Irvine
CONTACTUniversity of California Irvine Medical Center
PRINCIPAL_INVESTIGATORMichael Daneshvar, MD
Chao Family Comprehensive Cancer Center
Outcome results
None listed