Study of 18F-DCFPyL PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer
- Conditions
- Prostate Cancer MetastaticProstate Cancer RecurrentProstate CancerProstate Adenocarcinoma
- Interventions
- Drug: 18F-DCFPyLDiagnostic Test: PET/CT Imaging
- Registration Number
- NCT03739684
- Lead Sponsor
- Progenics Pharmaceuticals, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 208
-
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:
- 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
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 18F-DCFPyL Injection PET/CT Imaging 9 mCi (333 MBq) IV injection of 18F-DCFPyL 18F-DCFPyL Injection 18F-DCFPyL 9 mCi (333 MBq) IV injection of 18F-DCFPyL
- Primary Outcome Measures
Name Time Method Correct Localization Rate (CLR) 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With a Change in Intended Prostate Cancer Treatment Plans Due to 18F-DCFPyL PET/CT Imaging Results. 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.
The Change From Pre- to Post- 18F-DCFPyl Dosing in Blood Pressure (Safety Outcome Measure) 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.
The Change From Pre- to Post- 18F-DCFPyL Dosing in Heart Rate (Safety Outcome Measure) 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.
Collection of Medical Procedures (Safety Outcome Measure) 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.
Collection of Concomitant Medications (Safety Outcome Measure) 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.
Trial Locations
- Locations (14)
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
City of Hope National Medical Center
🇺🇸Duarte, California, United States
University of California San Francisco - Helen Diller Cancer Center
🇺🇸San Francisco, California, United States
Tower Urology
🇺🇸Los Angeles, California, United States
Stanford
🇺🇸Stanford, California, United States
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Chu de Quebec - Universite Laval
🇨🇦Quebec, Canada
Washington University - Mallinckrodt Institute of Radiology
🇺🇸Saint Louis, Missouri, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Yale University
🇺🇸New Haven, Connecticut, United States
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