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| ID | Type | Description | Link |
|---|---|---|---|
| UCI 25-100 | Other Identifier | UCI |
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| Name | Class |
|---|---|
| Blue Earth Diagnostics | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post-Focal Therapy Flotufolastat F18PET | Experimental | Post-Focal Therapy Flotufolastat F18 PET |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flotufolastat F18 PET | Diagnostic Test | Flotufolastat F18 PET |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Circulating Tumor Deoxyribonucleic acid (ctDNA) levels | Changes between timepoints in circulating tumor deoxyribonucleic acid (ctDNA) from baseline (pre-therapy) to the defined post-therapy timepoint. | 5 years |
| Changes in PSA levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chao Family Comprehensive Cancer Center University of California, Irvine | Contact | 1-877-827-8839 | ucstudy@uci.edu | |
| University of California Irvine Medical Center | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Michael Daneshvar, MD | Chao Family Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chao Family Comprehensive Cancer Center, University of California, Irvine | Orange | California | 92868 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Changes between timepoints in PSA from baseline (pre-therapy) to the defined post-therapy timepoint.
| 5 years |
| Change in genomic assay scores | Change in genomic assay scores as measured using each assay's validated soring system from baseline (pre-therapy) to the defined post-therapy timepoint. | 5 years |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |