Clinical trial NCT03739684: Study of 18F-DCFPyL PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer
Official title: A Phase 3, Multi-Center, Open-Label Study to Assess the Diagnostic Performance and Clinical Impact of 18F-DCFPyL PET/CT Imaging Results in Men With Suspected Recurrence of Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Prostate Adenocarcinoma
Prostate Cancer Recurrent
Prostate Cancer Metastatic
Keywords: Positron emission tomography
biochemical recurrence
rising PSA
PET/CT
Diagnostic
Imaging
PSMA
radical prostatectomy
BCR
Lead sponsor: Progenics Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2018-11-14
Enrollment: 208
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Correct Localization Rate (CLR)
timeFrame: Within 60 days following 18F-DCFPyL PET/CT imaging.
Secondary outcomes:
measure: Percentage of Participants With a Change in Intended Prostate Cancer Treatment Plans Due to 18F-DCFPyL PET/CT Imaging Results.
timeFrame: Pre 18F-DCFPyL PET/CT imaging and within 60 days following 18F-DCFPyL PET/CT imaging.
measure: The Change From Pre- to Post- 18F-DCFPyl Dosing in Blood Pressure (Safety Outcome Measure)
timeFrame: 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.
measure: The Change From Pre- to Post- 18F-DCFPyL Dosing in Heart Rate (Safety Outcome Measure)
timeFrame: 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.
measure: Collection of Concomitant Medications (Safety Outcome Measure)
timeFrame: From the time of 18F-DCFPyL dosing to completion of the follow-up visit at 7 (±3) days after 18F-DCFPyL dosing.
measure: Collection of Medical Procedures (Safety Outcome Measure)
timeFrame: From the time of 18F-DCFPyL dosing to completion of the follow-up visit at 7 (±3) days after 18F-DCFPyL dosing.
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Los Angeles
country: United States
facility: Tower Urology
state: California
city: San Francisco
country: United States
facility: University of California San Francisco - Helen Diller Cancer Center
state: California
city: Stanford
country: United States
facility: Stanford
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Saint Louis
country: United States
facility: Washington University - Mallinckrodt Institute of Radiology
state: Missouri
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Quebec
country: Canada
facility: Chu de Quebec - Universite Laval
Study officials:
affiliation: Progenics Pharmaceuticals, Inc.
name: Jessica D Jensen
role: STUDY_DIRECTOR
References: