Clinical trial NCT02981368: Study of 18F-DCFPyL PET/CT Imaging in Patients With Prostate Cancer
Official title: A PrOspective Phase 2/3 Multi-Center Study of 18F-DCFPyL PET/CT Imaging in Patients With PRostate Cancer: Examination of Diagnostic AccuracY (OSPREY)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Prostate Cancer
Keywords: Diagnostic
Imaging
2301
PET/CT
PyL
PSMA
radical prostatectomy
metastatic prostate cancer
recurrent prostate cancer
Lead sponsor: Progenics Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2016-12-05
Enrollment: 385
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 safety and diagnostic performance of 18F-DCFPyL Injection in patients with at least high risk prostate cancer who are planned for radical prostatectomy with lymphadenectomy (Cohort A) or in patients with locally recurrent or metastatic disease willing to undergo biopsy (Cohort B).

Cohort B is complete and no longer recruiting subjects.


Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed adenocarcinoma of the prostate.
2. Subjects provide signed informed consent and confirm that they are able and willing to comply with all protocol requirements.

Cohort A Only:

* At least high risk prostate cancer defined by NCCN Guidelines Version 3.2016 (clinical stage ≥T3a or PSA \>20 ng/mL or Gleason score ≥8).
* Scheduled or planned radical prostatectomy with PLND.

Cohort B Only: \[Enrollment is complete; No longer recruiting subjects\]

* Radiologic evidence of local recurrence or new or progressive metastatic disease demonstrated on anatomical imaging (CT, MRI, or ultrasound), whole-body bone scan (99m-Tc-MDP or Na-18F) within 4 weeks of enrollment.
* If prior treatment with radiation or ablative therapy, evidence of recurrence outside the confines of prior treated site(s) is needed.
* Scheduled or planned percutaneous biopsy of at least one amenable lesion.

Exclusion Criteria:

1. Subjects administered any high energy (\>300 KeV) gamma-emitting radioisotope within five physical half-lives, or any IV iodinated contrast medium within 24 hours, or any high density oral contrast medium (oral water contrast is acceptable) within 5 days, prior to study drug injection.
2. Subjects with any medical condition or other circumstance that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or completion.

Cohort A Only:

* Patients with prior androgen deprivation therapy or any investigational neoadjuvant agent or intervention

Cohort B Only: \[Enrollment is Complete; No longer recruiting subjects\]

* Prior radiation or ablative therapy to intended site of biopsy, if within the prostate bed
* Initiation of new therapy for recurrent and/or progressive metastatic disease since radiographic documentation of recurrence/progression.

Primary outcomes:
measure: Specificity of 18F-DCFPyL PET/CT Imaging to Detect Metastatic Prostate Cancer Within the Pelvic Lymph Nodes Relative to Histopathology in High Risk Prostate Cancer Participants (Cohort A)
timeFrame: Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.
measure: Sensitivity of 18F-DCFPyL PET/CT Imaging to Detect Metastatic Prostate Cancer Within the Pelvic Lymph Nodes Relative to Histopathology in High Risk Prostate Cancer Participants (Cohort A)
timeFrame: Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.
Secondary outcomes:
measure: Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure)
timeFrame: From time of screening (baseline) until pre-surgery/biopsy (within 28 days post-study drug dosing).
measure: Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure)
timeFrame: From time of screening (baseline) until pre-surgery/biopsy (within 28 days post-study drug dosing).
measure: Changes From Baseline in Electrocardiogram (ECG) Parameters (Safety Outcome Measure)
timeFrame: Changes in ECG pre-drug dosing and within 1-2 hours post-dosing
measure: Mean Changes From Baseline in Blood Pressure Post 18F-DCFPyL Dosing (Safety Outcome Measure)
timeFrame: Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging.
measure: Mean Change From Baseline in Heart Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure)
timeFrame: Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging.
measure: Mean Change From Baseline in Respiration Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure)
timeFrame: Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging.
measure: Mean Change From Baseline in Temperature Post 18F-DCFPyL Dosing (Safety Outcome Measure)
timeFrame: Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging.
measure: Sensitivity of 18F-DCFPyL PET/CT Imaging to Detect Prostate Cancer Within Sites of Metastasis or Local Recurrence Relative to Histopathology in Participants With Recurrent or Metastatic Prostate Cancer (Cohort B)
timeFrame: Within 28 days of 18F-DCFPyL PET/CT imaging, conventional image-guided biopsy occurred.
measure: Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging
timeFrame: Within 1-2 hours of 18F-DCFPyL dosing, a whole body PET/CT scan will be taken
measure: Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Prostate Gland of High Risk Prostate Cancer Participants (Cohort A)
timeFrame: Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.
measure: Negative Predictive Value (NPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Prostate Gland of High Risk Prostate Cancer Participants (Cohort A)
timeFrame: Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.
measure: Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Lymph Nodes of High Risk Prostate Cancer Participants (Cohort A)
timeFrame: Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.
measure: Negative Predictive Value (NPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Lymph Nodes of High Risk Prostate Cancer Participants (Cohort A)
timeFrame: Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.
measure: Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT Imaging to Predict Prostate Cancer Within Sites of Local Recurrence and Other Metastatic Lesions in Participants With Recurrent or Metastatic Prostate Cancer (Cohort B)
timeFrame: Within 28 days of 18F-DCFPyL PET/CT imaging, conventional image-guided biopsy will occur.
measure: Peak Plasma Concentration (Cmax) of 18F-DCFPyL in a Subset of Participants
timeFrame: Samples were collected at 0, 5, 15, 30, 60, 120, 240, 360, and 480 minutes after administration of 18F-DCFPyL.
measure: Area Under the Plasma Concentration Versus Time Curve (AUC) of 18F-DCFPyL in a Subset of Participants
timeFrame: Samples were collected at 0, 5, 15, 30, 60, 120, 240, 360, and 480 minutes after administration of 18F-DCFPyL.
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California at San Francisco (UCSF) - Mt. Zion Hospital
state: California
city: New Haven
country: United States
facility: Yale University Department of Radiology and Biomedical Imaging
state: Connecticut
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Cancer Center
state: Michigan
city: Saint Louis
country: United States
facility: Washington University Mallinckrodt Institute of Radilogy
state: Missouri
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Quebec
country: Canada
facility: Centre Hospitalier Universitaire de Quebec (CHUQ)
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Michael J Morris, MD
role: STUDY_CHAIR
affiliation: Johns Hopkins University
name: Kenneth J Pienta, MD
role: PRINCIPAL_INVESTIGATOR
References: