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

Completed · Phase 2/Phase 3

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT02981368

Run by

Progenics Pharmaceuticals, Inc.

People needed

385

Starts

2016-11-01

Expected to finish

2018-07-01

Last updated by the study team

2021-08-09

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed adenocarcinoma of the prostate.
• 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.

You may not qualify if…

• 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.
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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