Trial Outcomes & Findings for 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 (NCT NCT06604442)

Last Updated: 2026-05-12

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

62 participants

Primary outcome timeframe

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

Results posted on

2026-05-12

Participant Flow

Participant milestones

Participant milestones
Measure	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)
Overall Study STARTED	62
Overall Study COMPLETED	55
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Piflufolastat (18F) and Flotufolastat (18F) Positron Emission Tomography (PET) n=55 Participants 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)
Age, Categorical <=18 years	0 Participants n=1512 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=1512 Participants
Age, Categorical >=65 years	40 Participants n=1512 Participants
Sex: Female, Male Female	0 Participants n=1512 Participants
Sex: Female, Male Male	55 Participants n=1512 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=1512 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	50 Participants n=1512 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=1512 Participants
Race/Ethnicity, Customized Race · White	44 Participants n=1512 Participants
Race/Ethnicity, Customized Race · Black or African American	4 Participants n=1512 Participants
Race/Ethnicity, Customized Race · Asian	3 Participants n=1512 Participants
Race/Ethnicity, Customized Race · Not Reported	1 Participants n=1512 Participants
Race/Ethnicity, Customized Race · Unknown	2 Participants n=1512 Participants
Race/Ethnicity, Customized Race · Other	1 Participants n=1512 Participants
Baseline Weight	90.0 kg STANDARD_DEVIATION 16.60 • n=1512 Participants
Baseline Height	177.3 cm STANDARD_DEVIATION 7.70 • n=1512 Participants
Baseline Body Mass Index (kg/m2)	28.6 Kg/m2 STANDARD_DEVIATION 4.66 • n=1512 Participants

PRIMARY outcome

Timeframe: 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

Population: Efficacy Analysis Set

Outcome measures

Outcome measures
Measure	Piflufolastat (18F) PET n=55 Participants All participants who received both piflufolastat (18F) and flotufolastat (18F), and the corresponding PET scans	Flotufolastat (18F) PET n=55 Participants All participants who received both piflufolastat (18F) and flotufolastat (18F), and the corresponding PET scans	Flotufolastat (18F) PET; PSA > 0.2 ng/mL All participants who received both piflufolastat (18F) and flotufolastat (18F), and the corresponding PET scans and stratified by PSA	Piflufolastat (18F) PET; PSA > 0.2 ng/mL All participants who received both piflufolastat (18F) and flotufolastat (18F), and the corresponding PET scans and stratified by PSA
To Compare Urinary Bladder Radioactivity Observed on Piflufolastat (18F) PET and Flotufolastat (18F) PET.	29.0 ratio Interval 18.9 to 40.8	10.9 ratio Interval 6.0 to 18.5	—	—

SECONDARY outcome

Timeframe: 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

Population: Efficacy Analysis Set

Defined as the total number of patients with at least one PET positive lesion / total number of patients.

Outcome measures

Outcome measures
Measure	Piflufolastat (18F) PET n=55 Participants All participants who received both piflufolastat (18F) and flotufolastat (18F), and the corresponding PET scans	Flotufolastat (18F) PET n=55 Participants All participants who received both piflufolastat (18F) and flotufolastat (18F), and the corresponding PET scans	Flotufolastat (18F) PET; PSA > 0.2 ng/mL All participants who received both piflufolastat (18F) and flotufolastat (18F), and the corresponding PET scans and stratified by PSA	Piflufolastat (18F) PET; PSA > 0.2 ng/mL All participants who received both piflufolastat (18F) and flotufolastat (18F), and the corresponding PET scans and stratified by PSA
Patient Level Detection Rates Following Piflufolastat (18F) PET and Flotufolastat (18F) PET	27.3 percentage of participants Interval 16.1 to 41.0	45.5 percentage of participants Interval 32.0 to 59.4	—	—

SECONDARY outcome

Timeframe: 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

Defined as the total number of patients with at least one PET positive lesion / total number of patients in PSA group.

Outcome measures

Outcome measures
Measure	Piflufolastat (18F) PET n=21 Participants All participants who received both piflufolastat (18F) and flotufolastat (18F), and the corresponding PET scans	Flotufolastat (18F) PET n=21 Participants All participants who received both piflufolastat (18F) and flotufolastat (18F), and the corresponding PET scans	Flotufolastat (18F) PET; PSA > 0.2 ng/mL n=34 Participants All participants who received both piflufolastat (18F) and flotufolastat (18F), and the corresponding PET scans and stratified by PSA	Piflufolastat (18F) PET; PSA > 0.2 ng/mL n=34 Participants All participants who received both piflufolastat (18F) and flotufolastat (18F), and the corresponding PET scans and stratified by PSA
Patient Level Detection Rates Stratified by PSA Level Following Piflufolastat (18F) PET and Flotufolastat (18F) PET	52.4 percentage of participants Interval 29.8 to 74.3	38.1 percentage of participants Interval 18.1 to 61.6	41.2 percentage of participants Interval 24.6 to 59.3	20.6 percentage of participants Interval 8.7 to 37.9

SECONDARY outcome

Population: Efficacy Analysis Set, Diagnostic groups with outcome measures characterized by subregion

Outcome measures

Outcome measures
Measure	Piflufolastat (18F) PET n=55 Participants All participants who received both piflufolastat (18F) and flotufolastat (18F), and the corresponding PET scans	Flotufolastat (18F) PET n=55 Participants All participants who received both piflufolastat (18F) and flotufolastat (18F), and the corresponding PET scans	Flotufolastat (18F) PET; PSA > 0.2 ng/mL All participants who received both piflufolastat (18F) and flotufolastat (18F), and the corresponding PET scans and stratified by PSA	Piflufolastat (18F) PET; PSA > 0.2 ng/mL All participants who received both piflufolastat (18F) and flotufolastat (18F), and the corresponding PET scans and stratified by PSA
Detection Rate for Prostate Bed and Local Recurrences by Subregion Following for Piflufolastat (18F) PET and Flotufolastat (18F) PET Prostate Bed	18.2 percentage of participants Interval 9.1 to 30.9	10.9 percentage of participants Interval 4.1 to 22.2	—	—
Detection Rate for Prostate Bed and Local Recurrences by Subregion Following for Piflufolastat (18F) PET and Flotufolastat (18F) PET Remnant Seminal Vesicles/Lateral Surgical Margin	7.3 percentage of participants Interval 2.0 to 17.6	3.6 percentage of participants Interval 0.4 to 12.5	—	—
Detection Rate for Prostate Bed and Local Recurrences by Subregion Following for Piflufolastat (18F) PET and Flotufolastat (18F) PET Retrovesical	3.6 percentage of participants Interval 0.4 to 12.5	3.6 percentage of participants Interval 0.4 to 12.5	—	—
Detection Rate for Prostate Bed and Local Recurrences by Subregion Following for Piflufolastat (18F) PET and Flotufolastat (18F) PET Vesicourethral Anastomosis	7.3 percentage of participants Interval 2.0 to 17.6	1.8 percentage of participants Interval 0.0 to 9.7	—	—

SECONDARY outcome

Timeframe: 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

Population: Efficacy Analysis Set

Outcome measures

Outcome measures
Measure	Piflufolastat (18F) PET n=55 Participants All participants who received both piflufolastat (18F) and flotufolastat (18F), and the corresponding PET scans	Flotufolastat (18F) PET n=55 Participants All participants who received both piflufolastat (18F) and flotufolastat (18F), and the corresponding PET scans	Flotufolastat (18F) PET; PSA > 0.2 ng/mL All participants who received both piflufolastat (18F) and flotufolastat (18F), and the corresponding PET scans and stratified by PSA	Piflufolastat (18F) PET; PSA > 0.2 ng/mL All participants who received both piflufolastat (18F) and flotufolastat (18F), and the corresponding PET scans and stratified by PSA
Detection Rate for Pelvic Lymph Node (PLN) Following for Piflufolastat (18F) PET and Flotufolastat (18F) PET	16.4 percentage of participants Interval 7.8 to 28.8	14.5 percentage of participants Interval 6.5 to 26.7	—	—

Adverse Events

Piflufolastat (18F) PET

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Flotufolastat (18F) PET

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Piflufolastat (18F) PET n=62 participants at risk All patients who received piflufolastat (18F) and the corresponding PET scan	Flotufolastat (18F) PET n=57 participants at risk All patients who received flotufolastat (18F) and the corresponding PET scan
Respiratory, thoracic and mediastinal disorders Extortional dyspnoea	1.6% 1/62 • 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)	0.00% 0/57 • 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)

Other adverse events

Other adverse events
Measure	Piflufolastat (18F) PET n=62 participants at risk All patients who received piflufolastat (18F) and the corresponding PET scan	Flotufolastat (18F) PET n=57 participants at risk All patients who received flotufolastat (18F) and the corresponding PET scan
Gastrointestinal disorders Abdominal Discomfort	0.00% 0/62 • 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)	1.8% 1/57 • Number of events 1 • 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)
Gastrointestinal disorders Diarrhea	1.6% 1/62 • Number of events 1 • 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)	1.8% 1/57 • Number of events 1 • 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)
General disorders Fatigue	1.6% 1/62 • Number of events 1 • 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)	0.00% 0/57 • 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)
Nervous system disorders Taste Disorder	0.00% 0/62 • 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)	1.8% 1/57 • Number of events 1 • 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)
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	1.6% 1/62 • Number of events 1 • 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)	0.00% 0/57 • 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)
Vascular disorders Flushing	1.6% 1/62 • Number of events 1 • 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)	0.00% 0/57 • 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)

Additional Information

Head of Research and Development

Blue Earth Diagnostics

Phone: +44 (0) 1865 784 186

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place