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Trial record 1 of 1 for:    NCT02981368
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Study of 18F-DCFPyL PET/CT Imaging in Patients With Prostate Cancer (OSPREY)

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ClinicalTrials.gov Identifier: NCT02981368
Recruitment Status : Completed
First Posted : December 5, 2016
Results First Posted : August 9, 2021
Last Update Posted : August 9, 2021
Sponsor:
Information provided by (Responsible Party):
Progenics Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE November 22, 2016
First Posted Date  ICMJE December 5, 2016
Results First Submitted Date  ICMJE May 16, 2021
Results First Posted Date  ICMJE August 9, 2021
Last Update Posted Date August 9, 2021
Actual Study Start Date  ICMJE November 2016
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2021)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 30, 2016)
  • Sensitivity and Specificity of 18F-DCFPyL PET/CT imaging to detect prostate cancer within the prostate gland relative to histopathology in Cohort A [ Time Frame: Within 1-2 hours of dosing, whole body PET/CT scan will be taken ]
  • Sensitivity of 18F-DCFPyL PET/CT imaging to detect recurrent or metastatic prostate cancer relative to histopathology in Cohort B [ Time Frame: Within 1-2 hours of dosing, whole body PET/CT scan will be taken ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2021)
  • 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.
  • 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.
  • 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) [ 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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. ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2016)
  • Changes in clinical laboratory values [Safety and Tolerability] [ Time Frame: From time of screening until pre-surgery/biopsy (within 28 days post-study drug dosing) ]
  • Changes in ECG related to 18F-DCFPyL administration [Safety and Tolerability] [ Time Frame: Changes in ECG pre-drug dosing and within 1-2 hours post-dosing ]
  • Incidence of Treatment emergent adverse events [Safety and Tolerability] [ Time Frame: From study drug dosing until 10 days ]
  • Sensitivity and specificity of 18F-DCFPyL PET/CT imaging to detect prostate cancer within lymph nodes relative to histopathology [ Time Frame: Within 1-2 hours of dosing, whole body PET/CT scan will be taken ]
  • Lesion count in different locations as detected by 18F-DCFPyL vs. conventional imaging [ Time Frame: Within 1-2 hours of dosing, whole body PET/CT scan will be taken ]
  • Positive predictive value (PPV) of 18F-DCFPyL PET/CT imaging to predict prostate cancer within the prostate gland and lymph nodes in Cohort A [ Time Frame: Within 1-2 hours of dosing, whole body PET/CT scan will be taken ]
  • Negative predictive value (NPV) of 18F-DCFPyL PET/CT imaging to predict prostate cancer within the prostate gland and lymph nodes in Cohort A [ Time Frame: Within 1-2 hours of dosing, whole body PET/CT scan will be taken ]
  • Peak plasma concentration (Cmax) of 18F-DCFPyL in subset of patients [ Time Frame: At 0-8 hours post- dosing ]
    Summary statistics by timepoint
  • Area under the plasma concentration vs time curve (AUC) of 18F-DCFPyL in subset of patients [ Time Frame: At 0-8 hours post- dosing ]
    Summary statistics by timepoint
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: November 30, 2016)
Exploratory analysis of 18F-DCFPyL uptake in different lesion locations [ Time Frame: Within 1-2 hours of dosing, whole body PET/CT scan will be taken ]
 
Descriptive Information
Brief Title  ICMJE Study of 18F-DCFPyL PET/CT Imaging in Patients With Prostate Cancer
Official Title  ICMJE A PrOspective Phase 2/3 Multi-Center Study of 18F-DCFPyL PET/CT Imaging in Patients With PRostate Cancer: Examination of Diagnostic AccuracY (OSPREY)
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Drug: 18F-DCFPyL Injection
    A single dose of 9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL
    Other Name: PyL
  • Diagnostic Test: PET/CT imaging
    PET/CT imaging will be acquired 1-2 hours post-PyL injection
Study Arms  ICMJE Experimental: 18F-DCFPyL Injection
9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL
Interventions:
  • Drug: 18F-DCFPyL Injection
  • Diagnostic Test: PET/CT imaging
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 10, 2019)
385
Original Estimated Enrollment  ICMJE
 (submitted: November 30, 2016)
290
Actual Study Completion Date  ICMJE July 2018
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02981368
Other Study ID Numbers  ICMJE PyL 2301
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Progenics Pharmaceuticals, Inc.
Study Sponsor  ICMJE Progenics Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Michael J Morris, MD Memorial Sloan Kettering Cancer Center
Principal Investigator: Kenneth J Pienta, MD Johns Hopkins University
PRS Account Progenics Pharmaceuticals, Inc.
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP