Trial Outcomes & Findings for 18F-DCFPyL Positron Emission Tomography (PET) in Intermediate or High Risk Prostate Cancer (NCT NCT04727736)

NCT ID: NCT04727736

Last Updated: 2024-02-15

Results Overview

Number of patients with true positive scans (TP - positive test with disease) divided by number of TP plus number of false positive scans (FP - positive test without disease). A scan will be deemed 'positive' if at least one lesion suggestive of disease recurrence is noted. Prostate lesions and lymph nodes will be considered positive if the uptake in those lesions exceeds blood pool activity. Bone lesions will be recorded as positive if the activity is higher than normal bone marrow uptake.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 47 participants
• Primary outcome timeframe: Up to 12 months
• Results posted on: 2024-02-15

Participant Flow

Participant milestones

Measure	18F-DCFPyL + PET Imaging Participants will receive a single dose of 18F-DCFPyL and undergo a PET imaging study. (The PET imaging may be repeated at a later date if the biopsy of the lesion is negative and if the lesion is present on follow-up imaging.) 18F-DCFPyL: 18F-DCFPyL (single dose injection) - a radiolabeled prostate-specific membrane antigen (PSMA) ligand
Overall Study STARTED	47
Overall Study COMPLETED	47
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

18F-DCFPyL Positron Emission Tomography (PET) in Intermediate or High Risk Prostate Cancer

Baseline characteristics by cohort

Measure	18F-DCFPyL + PET Imaging n=47 Participants Participants will receive a single dose of 18F-DCFPyL and undergo a PET imaging study. (The PET imaging may be repeated at a later date if the biopsy of the lesion is negative and if the lesion is present on follow-up imaging.) 18F-DCFPyL: 18F-DCFPyL (single dose injection) - a radiolabeled prostate-specific membrane antigen (PSMA) ligand
Age, Continuous	67 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	47 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	43 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 12 months

Population: Male patients diagnosed with prostate cancer with increasing PSA levels.

Number of patients with true positive scans (TP - positive test with disease) divided by number of TP plus number of false positive scans (FP - positive test without disease). A scan will be deemed 'positive' if at least one lesion suggestive of disease recurrence is noted. Prostate lesions and lymph nodes will be considered positive if the uptake in those lesions exceeds blood pool activity. Bone lesions will be recorded as positive if the activity is higher than normal bone marrow uptake.

Outcome measures

Measure	18F-DCFPyL + PET Imaging n=47 Participants Participants will receive a single dose of 18F-DCFPyL and undergo a PET imaging study. (The PET imaging may be repeated at a later date if the biopsy of the lesion is negative and if the lesion is present on follow-up imaging.) 18F-DCFPyL: 18F-DCFPyL (single dose injection) - a radiolabeled prostate-specific membrane antigen (PSMA) ligand
Positive Predictive Value (PPV) (Per-patient)	83.9 Per-patient percentage Interval 66.3 to 94.5

SECONDARY outcome

Timeframe: Up to 12 months

Population: Male patients diagnosed with prostate cancer with increasing PSA levels.

Number of true positive scans (TP - positive test with disease) divided by number of TP plus number of false positive scans (FP - positive test without true disease), by region (prostate bed, locoregional lymph nodes, distant lymph nodes, bones, and/or visceral organs). A scan will be deemed 'positive' if at least one lesion suggestive of disease recurrence is noted. Prostate lesions and lymph nodes will be considered positive if the uptake in those lesions exceeds blood pool activity. Bone lesions will be recorded as positive if the activity is higher than normal bone marrow uptake.

Outcome measures

Measure	18F-DCFPyL + PET Imaging n=47 Participants Participants will receive a single dose of 18F-DCFPyL and undergo a PET imaging study. (The PET imaging may be repeated at a later date if the biopsy of the lesion is negative and if the lesion is present on follow-up imaging.) 18F-DCFPyL: 18F-DCFPyL (single dose injection) - a radiolabeled prostate-specific membrane antigen (PSMA) ligand
Positive Predictive Value (PPV) (Per-region) In prostate bed	50 percentage per anatomical region Interval 6.8 to 93.2
Positive Predictive Value (PPV) (Per-region) In LN pelvis	96 percentage per anatomical region Interval 79.6 to 99.9
Positive Predictive Value (PPV) (Per-region) In LN extra-pelvis	80 percentage per anatomical region Interval 28.4 to 99.5
Positive Predictive Value (PPV) (Per-region) In bone lesions	85.7 percentage per anatomical region Interval 42.1 to 99.6

Adverse Events

18F-DCFPyL + PET Imaging

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Barbara M Stadterman, Clinical Research Manager - Regulatory

UPMC Hillman Cancer Center

Phone: 412-647-5554

Email: stadtermanbm@upmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place