Study of 18F-DCFPyL PET/CT Imaging in Patients With Prostate Cancer

Progenics Pharmaceuticals, Inc.385 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

385

Conditions

Prostate Cancer

Interventions

18F-DCFPyL InjectionDRUG

A single dose of 9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL

PET/CT imagingDIAGNOSTIC_TEST

PET/CT imaging will be acquired 1-2 hours post-PyL injection

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (10)

University of California at San Francisco (UCSF) - Mt. Zion Hospital

San Francisco, California, United States

Yale University Department of Radiology and Biomedical Imaging

New Haven, Connecticut, United States

University of Chicago

Chicago, Illinois, United States

Outcomes

Primary Outcomes

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)

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.

Time frame: Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.

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)

Time frame: Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.

Secondary Outcomes

Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure)

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.

Time frame: From time of screening (baseline) until pre-surgery/biopsy (within 28 days post-study drug dosing).

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Johns Hopkins University

Baltimore, Maryland, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

University of Michigan Cancer Center

Ann Arbor, Michigan, United States

Washington University Mallinckrodt Institute of Radilogy

St Louis, Missouri, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Jewish General Hospital

Montreal, Quebec, Canada

Centre Hospitalier Universitaire de Quebec (CHUQ)

Québec, Canada

Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure)

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.

Time frame: From time of screening (baseline) until pre-surgery/biopsy (within 28 days post-study drug dosing).

Changes From Baseline in Electrocardiogram (ECG) Parameters (Safety Outcome Measure)

Time frame: Changes in ECG pre-drug dosing and within 1-2 hours post-dosing

Mean Changes From Baseline in Blood Pressure Post 18F-DCFPyL Dosing (Safety Outcome Measure)

Time frame: 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)

Time frame: Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging.

Mean Change From Baseline in Respiration Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure)

Time frame: 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)

Time frame: 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)

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).

Time frame: Within 28 days of 18F-DCFPyL PET/CT imaging, conventional image-guided biopsy occurred.

Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging

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.

Time frame: Within 1-2 hours of 18F-DCFPyL dosing, a whole body PET/CT scan will be taken

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)

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.

Time frame: Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.

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)

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.

Time frame: Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.

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)

Time frame: Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.

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)

Time frame: Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.

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)

Time frame: Within 28 days of 18F-DCFPyL PET/CT imaging, conventional image-guided biopsy will occur.

Peak Plasma Concentration (Cmax) of 18F-DCFPyL in a Subset of Participants

Time frame: Samples were collected at 0, 5, 15, 30, 60, 120, 240, 360, and 480 minutes after administration of 18F-DCFPyL.

Area Under the Plasma Concentration Versus Time Curve (AUC) of 18F-DCFPyL in a Subset of Participants

Time frame: Samples were collected at 0, 5, 15, 30, 60, 120, 240, 360, and 480 minutes after administration of 18F-DCFPyL.