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Study of 18F-DCFPyL PET/CT Imaging in Patients With Prostate Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2/PHASE3

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

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

NCT02981368•Progenics Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

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.

Locations (10)

University of California at San Francisco (UCSF) - Mt. Zion Hospital

San Francisco, California, United States

Yale University Department of Radiology and Biomedical Imaging

New Haven, Connecticut, United States

University of Chicago

Chicago, Illinois, United States

Johns Hopkins University

Baltimore, Maryland, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

University of Michigan Cancer Center

Ann Arbor, Michigan, United States

Washington University Mallinckrodt Institute of Radilogy

St Louis, Missouri, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Jewish General Hospital

Montreal, Quebec, Canada

Centre Hospitalier Universitaire de Quebec (CHUQ)

Québec, Canada

Key Dates

Start Date

November 1, 2016

Primary Completion Date

July 1, 2018

Completion Date

July 1, 2018

Last Updated

August 9, 2021

Enrollment

385

ACTUAL participants

Conditions

Prostate Cancer

Interventions

18F-DCFPyL Injection

DRUG

PET/CT imaging

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 9, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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