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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.

Study Description
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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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: 18F-DCFPyL Injection Diagnostic Test: PET/CT imaging Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 385 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A PrOspective Phase 2/3 Multi-Center Study of 18F-DCFPyL PET/CT Imaging in Patients With PRostate Cancer: Examination of Diagnostic AccuracY (OSPREY)
Actual Study Start Date : November 2016
Actual Primary Completion Date : July 2018
Actual Study Completion Date : July 2018

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Arms and Interventions
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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 Name: PyL

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


Outcome Measures
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Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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) ]
  2. 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 ]
  3. Incidence of Treatment emergent adverse events [Safety and Tolerability] [ Time Frame: From study drug dosing until 10 days ]
  4. 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. ]
  5. 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 ]
  6. 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. ]
  7. 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. ]
  8. Peak plasma concentration (Cmax) of 18F-DCFPyL in subset of patients [ Time Frame: At 0-8 hours post- dosing ]
    Summary statistics by timepoint

  9. 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


Other Outcome Measures:
  1. 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 ]
  2. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02981368


Locations
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United States, California
University of California at San Francisco (UCSF) - Mt. Zion Hospital
San Francisco, California, United States, 94143
United States, Connecticut
Yale University Department of Radiology and Biomedical Imaging
New Haven, Connecticut, United States, 06520
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Michigan
University of Michigan Cancer Center
Ann Arbor, Michigan, United States, 48109
United States, Missouri
Washington University Mallinckrodt Institute of Radilogy
Saint Louis, Missouri, United States, 63110
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada
Canada
Centre Hospitalier Universitaire de Quebec (CHUQ)
Quebec, Canada
Sponsors and Collaborators
Progenics Pharmaceuticals, Inc.
Investigators
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Study Chair: Michael J Morris, MD Memorial Sloan Kettering Cancer Center
Principal Investigator: Kenneth J Pienta, MD Johns Hopkins University
More Information
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Responsible Party: Progenics Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02981368    
Other Study ID Numbers: PyL 2301
First Posted: December 5, 2016    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Progenics Pharmaceuticals, Inc.:
Diagnostic
Imaging
2301
PET/CT
PyL
 PSMA
radical prostatectomy
metastatic prostate cancer
recurrent prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases