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

August 6, 2021 updated by: Progenics Pharmaceuticals, Inc.

A PrOspective Phase 2/3 Multi-Center Study of 18F-DCFPyL PET/CT Imaging in Patients With PRostate Cancer: Examination of Diagnostic AccuracY (OSPREY)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

385

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada
        • Centre Hospitalier Universitaire de Quebec (CHUQ)
    • Quebec
      • Montreal, Quebec, Canada
        • Jewish General Hospital
  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California at San Francisco (UCSF) - Mt. Zion Hospital
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University Department of Radiology and Biomedical Imaging
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer Institute
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Cancer Center
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University Mallinckrodt Institute of Radilogy
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 18F-DCFPyL Injection
9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL
Drug: 18F-DCFPyL Injection
A single dose of 9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL
Other Names:
  • PyL
Diagnostic test: PET/CT imaging
PET/CT imaging will be acquired 1-2 hours post-PyL injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: 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.
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.
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.
Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure)
Time Frame: 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.
From time of screening (baseline) until pre-surgery/biopsy (within 28 days post-study drug dosing).
Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure)
Time Frame: 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.
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
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.
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.
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.
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.
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)
Time Frame: 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).
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
Time Frame: 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.
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)
Time Frame: 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.
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)
Time Frame: 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.
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.
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.
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.
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.
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.
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.
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.
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.
Samples were collected at 0, 5, 15, 30, 60, 120, 240, 360, and 480 minutes after administration of 18F-DCFPyL.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Progenics Pharmaceuticals, Inc.

Investigators

  • Study Chair: Michael J Morris, MD, Memorial Sloan Kettering Cancer Center
  • Principal Investigator: Kenneth J Pienta, MD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

November 22, 2016

First Submitted That Met QC Criteria

November 30, 2016

First Posted (Estimate)

December 5, 2016

Study Record Updates

Last Update Posted (Actual)

August 9, 2021

Last Update Submitted That Met QC Criteria

August 6, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PyL 2301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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