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

This study is currently recruiting participants.
Verified November 2017 by Progenics Pharmaceuticals, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02981368
First Posted: December 5, 2016
Last Update Posted: November 20, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Progenics Pharmaceuticals, Inc.
  Purpose
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).

Condition Intervention Phase
Prostate Cancer Drug: 18F-DCFPyL Injection Phase 2 Phase 3

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Progenics Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • 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:
  • 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


Other Outcome Measures:
  • 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 ]

Estimated Enrollment: 377
Study Start Date: November 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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:

  • 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:

  • 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
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


Contacts
Contact: Thomas Strack, MD 646-975-2518 tstrack@progenics.com
Contact: Farnoush Faye Safavi 646-975-2680 fsafavi@progenics.com

Locations
United States, California
University of California at San Francisco (UCSF) - Mt. Zion Hospital Recruiting
San Francisco, California, United States, 94143
Contact: Imelda Tenggara    415-353-7348    imelda.tenggara@ucsf.edu   
Principal Investigator: Peter Carroll, MD         
United States, Connecticut
Yale University Department of Radiology and Biomedical Imaging Recruiting
New Haven, Connecticut, United States, 06520
Contact: Svetlana Vassilieva    203-785-5182    svetlana.vassilieva@yale.edu   
Principal Investigator: Lawrence Saperstein, MD         
Sub-Investigator: Preston Sprenkle, MD         
Sub-Investigator: Daniel Petrylak, MD         
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Benas Jakubauskas    773-702-3498      
Principal Investigator: Akash Patnaik, MD, PhD         
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Narineh Abrahamian    443-287-7790    nabrah10@jhmi.edu   
Principal Investigator: Kenneth Pienta, MD         
Sub-Investigator: Michael Gorin, MD         
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Samantha J Salvucci    617-732-5153    SJSalvucci@Partners.org   
Principal Investigator: Mark Preston, MD         
United States, Michigan
University of Michigan Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Cancer Center Hotline    800-865-1125    canceranswerline@med.umich.edu   
Principal Investigator: Ajjia Alva, MD         
United States, Missouri
Washington University Mallinckrodt Institute of Radilogy Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Jennifer Frye    314-747-1604    fryej@mir.wustl.edu   
Contact: Anna Self    314-362-2916    aself@wustl.edu   
Principal Investigator: Barry Siegel, MD         
Sub-Investigator: Gerald Andriole, MD         
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Nicole Parada    646-227-2160    paradan@mskcc.org   
Principal Investigator: Mike Morris, MD         
Canada, Quebec
Jewish General Hospital Recruiting
Montreal, Quebec, Canada
Contact: Stephan Probst, MD    514-340-8222 ext 4181    nukesmd@hotmail.com   
Principal Investigator: Gad Abikhzer, MD         
Principal Investigator: Stephan Probst, MD         
Canada
Centre Hospitalier Universitaire de Quebec (CHUQ) Recruiting
Quebec, Canada
Contact: Maria-Margarita Becerra-Perez    418-525-4444 ext 21623    maria-margarita.becerra-perez@crchudequebec.ulaval.ca   
Principal Investigator: Frederic Pouliot, MD         
Sponsors and Collaborators
Progenics Pharmaceuticals, Inc.
Investigators
Study Chair: Michael J Morris, MD Memorial Sloan Kettering Cancer Center
Principal Investigator: Kenneth J Pienta, MD Johns Hopkins University
  More Information

Responsible Party: Progenics Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02981368     History of Changes
Other Study ID Numbers: PyL 2301
First Submitted: November 22, 2016
First Posted: December 5, 2016
Last Update Posted: November 20, 2017
Last Verified: November 2017
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:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases