18 and older, male only, with Prostate Cancer or Prostate Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Correct Localization Rate (CLR)Primary· Within 60 days following 18F-DCFPyL PET/CT imaging.
The Correct Localization Rate (CLR) will be defined as percentage of participants with a one-to-one correspondence between localization of at least one lesion identified on 18F-DCFPyL PET/CT imaging and the composite truth standard. Within 60 days following PyL PET/CT imaging, either biopsy/surgery, conventional imaging, or locoregional radiation therapy of the PyL-suspected lesion(s) will be performed.
Central Reader 1
Group
Value
95% CI
18F-DCFPyL Injection
85.6
78.8 – 92.3
Central Reader 2
Group
Value
95% CI
18F-DCFPyL Injection
87.0
80.4 – 93.6
Central Reader 3
Group
Value
95% CI
18F-DCFPyL Injection
84.8
77.8 – 91.9
Percentage of Participants With a Change in Intended Prostate Cancer Treatment Plans Due to 18F-DCFPyL PET/CT Imaging Results.Secondary· Pre 18F-DCFPyL PET/CT imaging and within 60 days following 18F-DCFPyL PET/CT imaging.
The change in the intended prostate cancer treatment plan will be based on Medical Management Questionnaires completed prior to and after 18F-DCFPyL PET/CT imaging.
Group
Value
95% CI
18F-DCFPyL Injection
131
The Change From Pre- to Post- 18F-DCFPyl Dosing in Blood Pressure (Safety Outcome Measure)Secondary· Measured at 2 intervals on the day of dosing; the first interval prior to receiving the 18F-DCFPyL dose and the second interval within 60 to 120 minutes after dosing.
The recorded values and their respective changes from the pre-dose values will be summarized using descriptive statistics.
Systolic Blood Pressure: Baseline (actual)
Group
Value
95% CI
18F-DCFPyL Injection
138.9
± 18.61
Systolic Blood Pressure: Post-dosing (actual)
Group
Value
95% CI
18F-DCFPyL Injection
136.7
± 17.15
Systolic Blood Pressure: Change from Baseline
Group
Value
95% CI
18F-DCFPyL Injection
-2.2
± 13.24
Diastolic Blood Pressure: Baseline (actual)
Group
Value
95% CI
18F-DCFPyL Injection
78.5
± 10.18
Diastolic Blood Pressure: Post-dosing (actual)
Group
Value
95% CI
18F-DCFPyL Injection
77.3
± 9.57
Diastolic Blood Pressure: Change from Baseline
Group
Value
95% CI
18F-DCFPyL Injection
-1.2
± 8.20
The Change From Pre- to Post- 18F-DCFPyL Dosing in Heart Rate (Safety Outcome Measure)Secondary· Measured at 2 intervals on the day of dosing; the first interval prior to receiving the 18F-DCFPyL dose and the second interval within 60 to 120 minutes after dosing.
The recorded values and their respective changes from the pre-dose values will be summarized using descriptive statistics.
Heart Rate: Baseline (actual)
Group
Value
95% CI
18F-DCFPyL Injection
69.3
± 12.75
Heart Rate: Post-dosing (actual)
Group
Value
95% CI
18F-DCFPyL Injection
65.1
± 12.09
Heart Rate: Change from Baseline
Group
Value
95% CI
18F-DCFPyL Injection
-4.3
± 7.93
Collection of Concomitant Medications (Safety Outcome Measure)Secondary· From the time of 18F-DCFPyL dosing to completion of the follow-up visit at 7 (±3) days after 18F-DCFPyL dosing.
Medications will be coded using the WHO drug dictionary. The medications are summarized by ATC level 4 category and presented as number and percentage of participants.
Results are presented where the percentage of participants within an ATC level 4 category is \>5.0.
Collection of Medical Procedures (Safety Outcome Measure)Secondary· From the time of 18F-DCFPyL dosing to completion of the follow-up visit at 7 (±3) days after 18F-DCFPyL dosing.
Procedures will be coded using the same version of MedDRA as for medical history. Medical procedures will be displayed as a listing by participant.
Biopsy testes
Group
Value
95% CI
18F-DCFPyL Injection
1
Computerized tomogram
Group
Value
95% CI
18F-DCFPyL Injection
1
Nuclear magnetic resonance imaging
Group
Value
95% CI
18F-DCFPyL Injection
1
Ultrasound testes
Group
Value
95% CI
18F-DCFPyL Injection
1
Open reduction of fracture
Group
Value
95% CI
18F-DCFPyL Injection
1
Orchidectomy
Group
Value
95% CI
18F-DCFPyL Injection
1
Adverse events — posted to ClinicalTrials.gov
Time frame: Treatment-emergent adverse events were collected after 18F-DCFPyL administration on Day 1 post-dose through the safety visit 7 (±3) days post-dosing..
Reporting threshold: 1%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study evaluates the diagnostic performance and safety of 18F-DCFPyL (PyL) PET/CT imaging in patients with suspected recurrence of prostate cancer who have negative or equivocal findings on conventional imaging.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Progenics Pharmaceuticals, Inc.
Last refreshed: 14 June 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03739684.