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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02981368
Recruitment Status : Completed
First Posted : December 5, 2016
Last Update Posted : October 4, 2019
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
Last Update Posted Date October 4, 2019
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: November 16, 2017)
Sensitivity and Specificity of 18F-DCFPyL PET/CT imaging to detect metastatic prostate cancer within the pelvic lymph nodes relative to histopathology in Cohort A [ Time Frame: Within 1-2 hours of dosing, whole body PET/CT scan will be taken. Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur. ]
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 Complete list of historical versions of study NCT02981368 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2017)
  • 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 of 18F-DCFPyL PET/CT imaging to detect prostate cancer within sites of metastasis or local recurrence relative to histopathology in Cohort B [ Time Frame: Within 1-2 hours of dosing, whole body PET/CT scan will be taken. Within 28 days of imaging, biopsy will occur. ]
  • 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 and negative predictive values (PPV and 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. Within 28 days of imaging, radical prostatecomy with pelvic lymph node dissection will occur. ]
  • PPV of 18F-DCFPyL PET/CT imaging to predict prostate cancer within sites of local recurrence and other metastatic lesions in Cohort B [ Time Frame: Within 1-2 hours of dosing, whole body PET/CT scan will be taken. Within 28 days of imaging, biopsy will occur. ]
  • 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
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
 (submitted: November 16, 2017)
  • 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 ]
  • Pre-specified post hoc retrospective analysis of changes to clinical management plan based on central expert panel review of clinical and radiographic subject data before and after 18F-DCFPyL PET/CT scan results [ Time Frame: After enrollment is complete ]
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 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 September 2019

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