Study of 18F-DCFPyL PET/CT Imaging in Patients With Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Diagnostic Test: PET/CT imaging
- Registration Number
- NCT02981368
- Lead Sponsor
- Progenics Pharmaceuticals, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 385
- Histologically confirmed adenocarcinoma of the prostate.
- 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.
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 18F-DCFPyL Injection 18F-DCFPyL Injection 9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL 18F-DCFPyL Injection PET/CT imaging 9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL
- Primary Outcome Measures
Name Time Method 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) Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur. The primary analysis in Cohort A will test the co-primary endpoints of sensitivity and specificity of 18F-DCFPyL PET/CT imaging relative to histopathology for metastatic disease in pre-prostatectomy patients. For each co-primary endpoint there will be three independent imaging readers. At least two of the three readers must reject the null hypothesis for specificity to be deemed a success. If specificity is a success, then the same two readers need to reject the null hypothesis for sensitivity to reach overall success of the primary endpoint.
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) Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur. The primary analysis in Cohort A will test the co-primary endpoints of sensitivity and specificity of 18F-DCFPyL PET/CT imaging relative to histopathology for metastatic disease in pre-prostatectomy patients. For each co-primary endpoint there will be three independent imaging readers. At least two of the three readers must reject the null hypothesis for specificity to be deemed a success. If specificity is a success, then the same two readers need to reject the null hypothesis for sensitivity to reach overall success of the primary endpoint.
- Secondary Outcome Measures
Name Time Method Area Under the Plasma Concentration Versus Time Curve (AUC) of 18F-DCFPyL in a Subset of Participants Samples were collected at 0, 5, 15, 30, 60, 120, 240, 360, and 480 minutes after administration of 18F-DCFPyL. Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure) From time of screening (baseline) until pre-surgery/biopsy (within 28 days post-study drug dosing). Shifts from baseline to worst post-baseline visit for hematology laboratory values for all participants included in the Safety Set. The Safety Set includes all participants who received any amount of 18F-DCFPyL. Data are presented for participants in Cohort A and Cohort B.
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure) From time of screening (baseline) until pre-surgery/biopsy (within 28 days post-study drug dosing). Shifts from baseline to worst post-baseline visit for clinical chemistry laboratory values for all participants included in the Safety Set. The Safety Set includes all participants who received any amount of 18F-DCFPyL. Data are presented for participants in Cohort A and Cohort B.
Changes From Baseline in Electrocardiogram (ECG) Parameters (Safety Outcome Measure) Changes in ECG pre-drug dosing and within 1-2 hours post-dosing Mean Change From Baseline in Respiration Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure) Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging. Mean Change From Baseline in Temperature Post 18F-DCFPyL Dosing (Safety Outcome Measure) Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging. Mean Changes From Baseline in Blood Pressure Post 18F-DCFPyL Dosing (Safety Outcome Measure) Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging. Mean Change From Baseline in Heart Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure) Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging. 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) Within 28 days of 18F-DCFPyL PET/CT imaging, conventional image-guided biopsy occurred. Sensitivity (True Positive rate) measures the proportion of positives that are correctly identified (i.e., the proportion of those who have some condition (affected) who are correctly identified as having the condition).
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) Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur. Positive Predictive Value (PPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The PPV is determined from the number of true positives (positive 18F-DCFPyL image and a positive histopathology result for prostate cancer) divided by the number of participants with a positive 18F-DCFPyL image.
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) Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur. Negative Predictive Value (NPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The NPV is determined from the number of true negatives (negative 18F-DCFPyL image and a negative histopathology result for prostate cancer) divided by the number of participants with a negative 18F-DCFPyL image.
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) Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur. Positive Predictive Value (PPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The PPV is determined from the number of true positives (positive 18F-DCFPyL image and a positive histopathology result for prostate cancer) divided by the number of participants with a positive 18F-DCFPyL image.
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) Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur. Negative Predictive Value (NPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The NPV is determined from the number of true negatives (negative 18F-DCFPyL image and a negative histopathology result for prostate cancer) divided by the number of participants with a negative 18F-DCFPyL image.
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) Within 28 days of 18F-DCFPyL PET/CT imaging, conventional image-guided biopsy will occur. Positive Predictive Value (PPV) is based on a 18F-DCFPyL PET/CT image result and a histopathology result. The PPV is determined from the number of true positives (positive 18F-DCFPyL image and a positive histopathology result for prostate cancer) divided by the number of participants with a positive 18F-DCFPyL PET/CT image.
Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging Within 1-2 hours of 18F-DCFPyL dosing, a whole body PET/CT scan will be taken The number of lesions detected on imaging categorized as bone, visceral/soft tissue, lymph nodes, and the prostate gland will be determined by each of the central imaging core lab independent readers. The sum of lesions per participant per tissue type and overall will be computed for each participant based on each reader's lesion count. This will be calculated from the 18F-DCFPyL PET/CT scan results as well as the conventional imaging results.
Peak Plasma Concentration (Cmax) of 18F-DCFPyL in a Subset of Participants Samples were collected at 0, 5, 15, 30, 60, 120, 240, 360, and 480 minutes after administration of 18F-DCFPyL.
Trial Locations
- Locations (10)
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
University of California at San Francisco (UCSF) - Mt. Zion Hospital
🇺🇸San Francisco, California, United States
Washington University Mallinckrodt Institute of Radilogy
🇺🇸Saint Louis, Missouri, United States
Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec (CHUQ)
🇨🇦Quebec, Canada
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
University of Michigan Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Yale University Department of Radiology and Biomedical Imaging
🇺🇸New Haven, Connecticut, United States