TriangleNCT03739684 · STUDY IN CONTEXT
Study of 18F-DCFPyL PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer
Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
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.
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.
The recorded values and their respective changes from the pre-dose values will be summarized using descriptive statistics.
The recorded values and their respective changes from the pre-dose values will be summarized using descriptive statistics.
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.
Procedures will be coded using the same version of MedDRA as for medical history. Medical procedures will be displayed as a listing by participant.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-recurrent-d5088116
- nct id
- NCT03739684
- trial label
- Study of 18F-DCFPyL PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer
- applicability
- unclear
- applicability note
- Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 6
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-recurrent-d5088116
- nct id
- NCT03739684
- outcome key
- om-0000
- source section id
- NCT03739684-om-0000
- source outcome index
- 0
- endpoint
- Correct Localization Rate (CLR)
- endpoint definition
- 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.
- time origin
- Within 60 days following 18F-DCFPyL PET/CT imaging.
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants who received any amount of 18F-DCFPyL and had a 18F-DCFPyL PET/CT central imaging reader result.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-recurrent-d5088116
- nct id
- NCT03739684
- outcome key
- om-0001
- source section id
- NCT03739684-om-0001
- source outcome index
- 1
- endpoint
- Percentage of Participants With a Change in Intended Prostate Cancer Treatment Plans Due to 18F-DCFPyL PET/CT Imaging Results.
- endpoint definition
- 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.
- time origin
- Pre 18F-DCFPyL PET/CT imaging and within 60 days following 18F-DCFPyL PET/CT imaging.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants with a Medical Management Questionnaire (MMQ) completed at pre- and post- 18F-DCFPyL PET/CT imaging.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-recurrent-d5088116
- nct id
- NCT03739684
- outcome key
- om-0002
- source section id
- NCT03739684-om-0002
- source outcome index
- 2
- endpoint
- The Change From Pre- to Post- 18F-DCFPyl Dosing in Blood Pressure (Safety Outcome Measure)
- endpoint definition
- The recorded values and their respective changes from the pre-dose values will be summarized using descriptive statistics.
- time origin
- 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.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The Safety Set includes all participants who received any amount of 18F-DECPyL.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-recurrent-d5088116
- nct id
- NCT03739684
- outcome key
- om-0003
- source section id
- NCT03739684-om-0003
- source outcome index
- 3
- endpoint
- The Change From Pre- to Post- 18F-DCFPyL Dosing in Heart Rate (Safety Outcome Measure)
- endpoint definition
- The recorded values and their respective changes from the pre-dose values will be summarized using descriptive statistics.
- time origin
- 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.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The Safety Set includes all participants who received any amount of 18F-DCFPyL.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-recurrent-d5088116
- nct id
- NCT03739684
- outcome key
- om-0004
- source section id
- NCT03739684-om-0004
- source outcome index
- 4
- endpoint
- Collection of Concomitant Medications (Safety Outcome Measure)
- endpoint definition
- 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.
- time origin
- From the time of 18F-DCFPyL dosing to completion of the follow-up visit at 7 (±3) days after 18F-DCFPyL dosing.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The Safety Set includes all participants who received any amount of 18F-DCFPyL.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-recurrent-d5088116
- nct id
- NCT03739684
- outcome key
- om-0005
- source section id
- NCT03739684-om-0005
- source outcome index
- 5
- endpoint
- Collection of Medical Procedures (Safety Outcome Measure)
- endpoint definition
- Procedures will be coded using the same version of MedDRA as for medical history. Medical procedures will be displayed as a listing by participant.
- time origin
- From the time of 18F-DCFPyL dosing to completion of the follow-up visit at 7 (±3) days after 18F-DCFPyL dosing.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The Safety Set includes all participants who received any amount of 18F-DCFPyL.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-recurrent-d5088116
- nct id
- NCT03739684
- outcome key
- om-0000
- arm key
- OG000
- arm label
- 18F-DCFPyL Injection
- regimen
- Participants with suspected recurrence of prostate cancer and negative or equivocal findings per institutional standard of care conventional imaging were enrolled to receive a single dose of 9 mCi (333 MBq) 18F-DCFPyL injection followed by a single PET/CT scan acquired 1 to 2 hours post-dosing.
- analyzed count
- 208
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03739684-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-recurrent-d5088116
- nct id
- NCT03739684
- outcome key
- om-0001
- arm key
- OG000
- arm label
- 18F-DCFPyL Injection
- regimen
- Participants with suspected recurrence of prostate cancer and negative or equivocal findings per institutional standard of care conventional imaging were enrolled to receive a single dose of 9 mCi (333 MBq) 18F-DCFPyL injection followed by a single PET/CT scan acquired 1 to 2 hours post-dosing.
- analyzed count
- 205
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03739684-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-recurrent-d5088116
- nct id
- NCT03739684
- outcome key
- om-0002
- arm key
- OG000
- arm label
- 18F-DCFPyL Injection
- regimen
- Participants with suspected recurrence of prostate cancer and negative or equivocal findings per institutional standard of care conventional imaging were enrolled to receive a single dose of 9 mCi (333 MBq) 18F-DCFPyL injection followed by a single PET/CT scan acquired 1 to 2 hours post-dosing.
- analyzed count
- 208
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03739684-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-recurrent-d5088116
- nct id
- NCT03739684
- outcome key
- om-0003
- arm key
- OG000
- arm label
- 18F-DCFPyL Injection
- regimen
- Participants with suspected recurrence of prostate cancer and negative or equivocal findings per institutional standard of care conventional imaging were enrolled to receive a single dose of 9 mCi (333 MBq) 18F-DCFPyL injection followed by a single PET/CT scan acquired 1 to 2 hours post-dosing.
- analyzed count
- 208
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03739684-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-recurrent-d5088116
- nct id
- NCT03739684
- outcome key
- om-0004
- arm key
- OG000
- arm label
- 18F-DCFPyL Injection
- regimen
- Participants with suspected recurrence of prostate cancer and negative or equivocal findings per institutional standard of care conventional imaging were enrolled to receive a single dose of 9 mCi (333 MBq) 18F-DCFPyL injection followed by a single PET/CT scan acquired 1 to 2 hours post-dosing.
- analyzed count
- 208
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03739684-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-recurrent-d5088116
- nct id
- NCT03739684
- outcome key
- om-0005
- arm key
- OG000
- arm label
- 18F-DCFPyL Injection
- regimen
- Participants with suspected recurrence of prostate cancer and negative or equivocal findings per institutional standard of care conventional imaging were enrolled to receive a single dose of 9 mCi (333 MBq) 18F-DCFPyL injection followed by a single PET/CT scan acquired 1 to 2 hours post-dosing.
- analyzed count
- 208
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03739684-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-prostate-cancer-recurrent-d5088116
- nct id
- NCT03739684
- harm key
- EG000
- source section id
- NCT03739684-ae
- event group key
- EG000
- event group label
- 18F-DCFPyL Injection
- serious affected
- 1
- serious at risk
- 208
- other affected
- 7
- other at risk
- 208
- frequency threshold
- 1
- collection period
- Treatment-emergent adverse events were collected after 18F-DCFPyL administration on Day 1 post-dose through the safety visit 7 (±3) days post-dosing.
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice