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| Name | Class |
|---|---|
| Aixial Group | INDUSTRY |
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Intrapatient Comparison of Urinary Radioactivity Following Piflufolastat (18F) and Flotufolastat (18F) PET in Men with Low PSA Biochemical Recurrence of Prostate Cancer Following Radical Prostatectomy
This is a multi-center, prospective intra-patient comparator study of urinary radioactivity (standardized uptake values [SUV]) following both piflufolastat (18F) and flotufolastat (18F) positron emission tomography (PET) in patients with low prostate-specific antigen (PSA; ≤0.5 ng/mL) biochemical recurrence (BCR) of prostate cancer following radical prostatectomy (RP).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| piflufolastat (18F) and flotufolastat (18F) positron emission tomography (PET) | Experimental | Each patient will be administered a single dose of piflufolastat (18F) on Day 1, followed by a PET scan. At least 24 hours after the piflufolastat (18F) scan, but within 10 calendar days, all patients will be administered a single dose of flotufolastat (18F) followed by a PET scan. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| flotufolastat (18F) | Drug | Positron emission tomography (PET) |
|
| Measure | Description | Time Frame |
|---|---|---|
| To Compare Urinary Bladder Radioactivity Observed on Piflufolastat (18F) PET and Flotufolastat (18F) PET. | Difference in urinary bladder mean SUV (SUVmean) between piflufolastat (18F) and flotufolastat (18F). A positive difference represents a lower bladder SUVmean for flotufolastat (18F) compared to piflufolastat (18F). | piflufolastat (18F) administration and PET on Day 1; and flotufolastat (18F) administration and PET at least 24 hours after the piflufolastat (18F) scan but within 10 calendar days |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Level Detection Rates Following Piflufolastat (18F) PET and Flotufolastat (18F) PET | Defined as the total number of patients with at least one PET positive lesion / total number of patients. | piflufolastat (18F) administration and PET on Day 1; and flotufolastat (18F) administration and PET at least 24 hours after the piflufolastat (18F) scan but within 10 calendar days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Helfand, M.D. | Endeavor Health NorthShore Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Phoenix | Arizona | 85054 | United States | ||
| City of Hope Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41729277 | Derived | Nordquist LT, Andrews JR, Kuo PH, Gartrell BA, Josephson D, Purysko AS, Saltzstein DR, Pathak RA, Shore N, Sykes J, Penny R, Davis P, Helfand BT. An intra-patient contemporaneous comparison of 18F-piflufolastat and 18F-flotufolastat urinary radioactivity and pelvic region detection rates in men with low PSA biochemical recurrence of prostate cancer after radical prostatectomy. Eur J Nucl Med Mol Imaging. 2026 May;53(6):3529-3541. doi: 10.1007/s00259-025-07732-y. Epub 2026 Feb 23. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Piflufolastat (18F) and Flotufolastat (18F) Positron Emission Tomography (PET) | Each patient will be administered a single dose of piflufolastat (18F) on Day 1, followed by a PET scan. At least 24 hours after the piflufolastat (18F) scan, but within 10 calendar days, all patients will be administered a single dose of flotufolastat (18F) followed by a PET scan. Flotufolastat (18F): Positron emission tomography (PET) piflufolastat (18F): Positron emission tomography (PET) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 22, 2025 | Mar 4, 2026 |
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Positron Emission Tomography (PET) Imaging study
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| piflufolastat (18F) | Drug | Positron emission tomography (PET) |
|
| Patient Level Detection Rates Stratified by PSA Level Following Piflufolastat (18F) PET and Flotufolastat (18F) PET | Defined as the total number of patients with at least one PET positive lesion / total number of patients in PSA group. | Screening, piflufolastat (18F) administration and PET on Day 1; and flotufolastat (18F) administration and PET at least 24 hours after the piflufolastat (18F) scan but within 10 calendar days |
| Detection Rate for Prostate Bed and Local Recurrences by Subregion Following for Piflufolastat (18F) PET and Flotufolastat (18F) PET | Screening, piflufolastat (18F) administration and PET on Day 1; and flotufolastat (18F) administration and PET at least 24 hours after the piflufolastat (18F) scan but within 10 calendar days |
| Detection Rate for Pelvic Lymph Node (PLN) Following for Piflufolastat (18F) PET and Flotufolastat (18F) PET | Piflufolastat (18F) administration and PET on Day 1; and flotufolastat (18F) administration and PET at least 24 hours after the piflufolastat (18F) scan but within 10 calendar days |
| Duarte |
| California |
| 91010 |
| United States |
| Tower Urology | Los Angeles | California | 90048 | United States |
| Mayo Clinic | Jacksonville | Florida | 32224 | United States |
| Endeavor Health- Glenbrook Hospital | Glenview | Illinois | 60026 | United States |
| XCancer Omaha/Urology Cancer Center | Omaha | Nebraska | 68130 | United States |
| Montefiore Medical Center | The Bronx | New York | 10461 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Urology San Antonio | San Antonio | Texas | 78229 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Piflufolastat (18F) and Flotufolastat (18F) Positron Emission Tomography (PET) | Each patient will be administered a single dose of piflufolastat (18F) on Day 1, followed by a PET scan. At least 24 hours after the piflufolastat (18F) scan, but within 10 calendar days, all patients will be administered a single dose of flotufolastat (18F) followed by a PET scan. Flotufolastat (18F): Positron emission tomography (PET) piflufolastat (18F): Positron emission tomography (PET) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Baseline Weight | Mean | Standard Deviation | kg |
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| Baseline Height | Mean | Standard Deviation | cm |
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| Baseline Body Mass Index (kg/m2) | Mean | Standard Deviation | Kg/m2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | To Compare Urinary Bladder Radioactivity Observed on Piflufolastat (18F) PET and Flotufolastat (18F) PET. | Difference in urinary bladder mean SUV (SUVmean) between piflufolastat (18F) and flotufolastat (18F). A positive difference represents a lower bladder SUVmean for flotufolastat (18F) compared to piflufolastat (18F). | Efficacy Analysis Set | Posted | Median | Inter-Quartile Range | ratio | piflufolastat (18F) administration and PET on Day 1; and flotufolastat (18F) administration and PET at least 24 hours after the piflufolastat (18F) scan but within 10 calendar days |
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| Secondary | Patient Level Detection Rates Following Piflufolastat (18F) PET and Flotufolastat (18F) PET | Defined as the total number of patients with at least one PET positive lesion / total number of patients. | Efficacy Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participants | piflufolastat (18F) administration and PET on Day 1; and flotufolastat (18F) administration and PET at least 24 hours after the piflufolastat (18F) scan but within 10 calendar days |
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| Secondary | Patient Level Detection Rates Stratified by PSA Level Following Piflufolastat (18F) PET and Flotufolastat (18F) PET | Defined as the total number of patients with at least one PET positive lesion / total number of patients in PSA group. | Posted | Number | 95% Confidence Interval | percentage of participants | Screening, piflufolastat (18F) administration and PET on Day 1; and flotufolastat (18F) administration and PET at least 24 hours after the piflufolastat (18F) scan but within 10 calendar days |
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| Secondary | Detection Rate for Prostate Bed and Local Recurrences by Subregion Following for Piflufolastat (18F) PET and Flotufolastat (18F) PET | Efficacy Analysis Set, Diagnostic groups with outcome measures characterized by subregion | Posted | Number | 95% Confidence Interval | percentage of participants | Screening, piflufolastat (18F) administration and PET on Day 1; and flotufolastat (18F) administration and PET at least 24 hours after the piflufolastat (18F) scan but within 10 calendar days |
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| Secondary | Detection Rate for Pelvic Lymph Node (PLN) Following for Piflufolastat (18F) PET and Flotufolastat (18F) PET | Efficacy Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participants | Piflufolastat (18F) administration and PET on Day 1; and flotufolastat (18F) administration and PET at least 24 hours after the piflufolastat (18F) scan but within 10 calendar days |
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A TEAE is defined as an AE that started or worsened after administration of piflufolastat up to the final safety monitoring telephone call after the administration of flotufolastat (18F). Adverse events were collected starting from administration of piflufolastat (18F) through 24 hour safety telephone call post administration of flotufolastat (18F)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Piflufolastat (18F) PET | All patients who received piflufolastat (18F) and the corresponding PET scan | 0 | 62 | 1 | 62 | 3 | 62 |
| EG001 | Flotufolastat (18F) PET | All patients who received flotufolastat (18F) and the corresponding PET scan | 0 | 57 | 0 | 57 | 2 | 57 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Extortional dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Discomfort | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Taste Disorder | Nervous system disorders | Systematic Assessment |
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| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Flushing | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Research and Development | Blue Earth Diagnostics | +44 (0) 1865 784 186 | matthew.miller@blueearthdx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 24, 2025 | Mar 4, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| Unknown or Not Reported |
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| Asian |
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| Not Reported |
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| Unknown |
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| Other |
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All participants who received both piflufolastat (18F) and flotufolastat (18F), and the corresponding PET scans and stratified by PSA |
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