TriangleNCT03739684 · CITED IN SOURCE DOCUMENTS
Study of 18F-DCFPyL PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2021-06-14
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Correct Localization Rate (CLR)
Percentage of Participants With a Change in Intended Prostate Cancer Treatment Plans Due to 18F-DCFPyL PET/CT Imaging Results.
The Change From Pre- to Post- 18F-DCFPyl Dosing in Blood Pressure (Safety Outcome Measure)
The Change From Pre- to Post- 18F-DCFPyL Dosing in Heart Rate (Safety Outcome Measure)
Collection of Concomitant Medications (Safety Outcome Measure)
Collection of Medical Procedures (Safety Outcome Measure)
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion Criteria: * Male \>/= 18 years of age * Histopathologically confirmed prostate adenocarcinoma per original diagnosis, with subsequent definitive therapy * Suspected recurrence of prostate cancer based on rising PSA after definitive therapy on the basis of: 1. Post-radical prostatectomy: Detectable or rising PSA that is ≥ 0.2 ng/mL with a confirmatory PSA ≥ 0.2 ng/mL (American Urological Association \[AUA\]); or 2. Post-radiation therapy, cryotherapy, or brachytherapy: Increase in PSA level that is elevated by ≥ 2 ng/mL above the nadir (American Society for Therapeutic Radiology and Oncology \[ASTRO\]-Phoenix) * Negative or equivocal findings for prostate cancer on conventional imaging performed as part of standard of care workup within 60 days prior to Day 1 * Life expectancy ≥6 months as determined by the investigator * Able and willing to provide informed consent and comply with protocol requirements Exclusion Criteria: * Subjects administered any high energy (\>300 KeV) gamma-emitting radioisotope within five (5) physical half-lives prior to Day 1 * Ongoing treatment with any systemic therapy (e.g. ADT, antiandrogen, GnRH, LHRH agonist or antagonist) for prostate cancer * Treatment with ADT in the past 3 months of Day 1 * Receipt of investigational therapy for prostate cancer within 60 days of Day 1 * Subjects with any medical condition or other circumstances that, in the opinion of the investigator, compromise the safety or compliance of the subject to produce reliable data or completing the study
- gender Based
- true
- gender Description
- Only males subjects will be enrolled in this study.
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- MALE
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- 9 mCi (333 MBq) IV injection of 18F-DCFPyL
- intervention Names
- Drug: 18F-DCFPyL
- Diagnostic Test: PET/CT Imaging
- label
- 18F-DCFPyL Injection
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- 18F-DCFPyL Injection
- description
- A single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL
- name
- 18F-DCFPyL
- other Names
- PyL
- type
- DRUG
- arm Group Labels
- 18F-DCFPyL Injection
- description
- PET/CT imaging will be acquired 1-2 hours post-PyL injection
- name
- PET/CT Imaging
- type
- DIAGNOSTIC_TEST
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- DIAGNOSTIC
Enrollment
- count
- 208
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- 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.
- measure
- Correct Localization Rate (CLR)
- time Frame
- Within 60 days following 18F-DCFPyL PET/CT imaging.
- secondary Outcomes
- description
- 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.
- measure
- Percentage of Participants With a Change in Intended Prostate Cancer Treatment Plans Due to 18F-DCFPyL PET/CT Imaging Results.
- time Frame
- Pre 18F-DCFPyL PET/CT imaging and within 60 days following 18F-DCFPyL PET/CT imaging.
- description
- The recorded values and their respective changes from the pre-dose values will be summarized using descriptive statistics.
- measure
- The Change From Pre- to Post- 18F-DCFPyl Dosing in Blood Pressure (Safety Outcome Measure)
- time Frame
- 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.
- description
- The recorded values and their respective changes from the pre-dose values will be summarized using descriptive statistics.
- measure
- The Change From Pre- to Post- 18F-DCFPyL Dosing in Heart Rate (Safety Outcome Measure)
- time Frame
- 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.
- description
- 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.
- measure
- Collection of Concomitant Medications (Safety Outcome Measure)
- time Frame
- From the time of 18F-DCFPyL dosing to completion of the follow-up visit at 7 (±3) days after 18F-DCFPyL dosing.
- description
- Procedures will be coded using the same version of MedDRA as for medical history. Medical procedures will be displayed as a listing by participant.
- measure
- Collection of Medical Procedures (Safety Outcome Measure)
- time Frame
- From the time of 18F-DCFPyL dosing to completion of the follow-up visit at 7 (±3) days after 18F-DCFPyL dosing.
Full study description
- brief Summary
- 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.
Source references
- references
- citation
- Agarwal G, Sangwan K. FDA-Approved Radiopharmaceuticals in Oncologic PET Imaging: Current Status and Clinical Impact. Am J Clin Oncol. 2026 Mar 4. doi: 10.1097/COC.0000000000001314. Online ahead of print.
- pmid
- 41806372
- type
- DERIVED
Source notices and limitations
Discovery and provenance
- release id
- ctgov-registry-7ad944f6deaf1f5cd6122126
- edge id
- nct-edge-8ee6bf160aec8476a183
- requested nct id
- NCT03739684
- primary nct id
- NCT03739684
- source kind
- fda_spl_label
- source record id
- 558f7e93-a905-767a-e063-6294a90a1527
- source file sha256
- bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
- payload sha256
- a803f4ce4b034830438bf74cdd6763e91d9ea39da01e337d2ada9f7aea82bb01
- payload
- application numbers
- NDA220089
- clinical indication matching status
- not_inferred
- end exclusive
- true
- id
- nct-edge-8ee6bf160aec8476a183
- link basis
- explicit_NCT_identifier_in_acquired_source
- nct id
- NCT03739684
- occurrences
- context exact
- ospective, open-label, multi-center clinical studies of another formulation of piflufolastat F 18 in men with prostate cancer: OSPREY (NCT02981368) and CONDOR (NCT03739684). The results of these two studies are presented below. OSPREY OSPREY enrolled a cohort of 268 men with biopsy-proven prostate cancer who were considered candi
- end
- 285
- exact text
- NCT03739684
- start
- 274
- offset unit
- unicode_code_points
- source file
- /tmp/cancer-full-research/indications/raw/labels-00300.json
- source file sha256
- bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
- source json pointer
- /results/55/clinical_studies/0
- source kind
- fda_spl_label
- source record id
- 558f7e93-a905-767a-e063-6294a90a1527
- source string basis
- parsed_JSON_string_unmodified
- source string sha256
- 75b7617538408880c08714b72038f16c454f10f371171c6b22ebb55a19dbef93
- spl effective time
- 20260701
- spl set id
- 121c1cb8-6f60-4644-a775-b81c6f21d812
- release id
- ctgov-registry-7ad944f6deaf1f5cd6122126
- edge id
- nct-edge-cdfbca0ac83236731a30
- requested nct id
- NCT03739684
- primary nct id
- NCT03739684
- source kind
- fda_spl_label
- source record id
- db2acb00-3e3b-4ecc-b532-08e456075404
- source file sha256
- 24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
- payload sha256
- 6582cedb386db182b8a7279012630cfcc3057c30759cd694cd3661cb66ad5fd8
- payload
- application numbers
- NDA214793
- clinical indication matching status
- not_inferred
- end exclusive
- true
- id
- nct-edge-cdfbca0ac83236731a30
- link basis
- explicit_NCT_identifier_in_acquired_source
- nct id
- NCT03739684
- occurrences
- context exact
- efficacy of PYLARIFY were evaluated in two prospective, open-label, multi-center clinical studies in men with prostate cancer: OSPREY (NCT02981368) and CONDOR (NCT03739684). OSPREY OSPREY enrolled a cohort of 268 men with biopsy-proven prostate cancer who were considered candidates for radical prostatectomy and pelvic lymph node
- end
- 206
- exact text
- NCT03739684
- start
- 195
- offset unit
- unicode_code_points
- source file
- /tmp/cancer-full-research/indications/raw/labels-00700.json
- source file sha256
- 24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
- source json pointer
- /results/23/clinical_studies/0
- source kind
- fda_spl_label
- source record id
- db2acb00-3e3b-4ecc-b532-08e456075404
- source string basis
- parsed_JSON_string_unmodified
- source string sha256
- e45d590a778b152334dad5711f48c1cd04211cd8016916190739af57fcf42fcf
- spl effective time
- 20260218
- spl set id
- a00e5cbc-4fd5-4280-82ec-cd3498df4553
Preserved source evidence · Not medical advice