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

Completed · Phase 3

Conditions studied: Prostate Cancer, Prostate Adenocarcinoma, Prostate Cancer Recurrent, Prostate Cancer Metastatic

In brief

This study evaluates the diagnostic performance and safety of 18F-DCFPyL (PyL) PET/CT imaging in patients with suspected recurrence of prostate cancer who have negative or equivocal findings on conventional imaging.

Key facts

Study ID

NCT03739684

Run by

Progenics Pharmaceuticals, Inc.

People needed

208

Starts

2018-11-27

Expected to finish

2019-08-29

Last updated by the study team

2021-06-14

Who can join

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

You may qualify if…

• Male >/= 18 years of age
• Histopathologically confirmed prostate adenocarcinoma per original diagnosis, with subsequent definitive therapy
• Suspected recurrence of prostate cancer based on rising PSA after definitive therapy on the basis of:
• Post-radical prostatectomy: Detectable or rising PSA that is ≥ 0.2 ng/mL with a confirmatory PSA ≥ 0.2 ng/mL (American Urological Association [AUA]); or
• Post-radiation therapy, cryotherapy, or brachytherapy: Increase in PSA level that is elevated by ≥ 2 ng/mL above the nadir (American Society for Therapeutic Radiology and Oncology [ASTRO]-Phoenix)
• Negative or equivocal findings for prostate cancer on conventional imaging performed as part of standard of care workup within 60 days prior to Day 1
• Life expectancy ≥6 months as determined by the investigator
• Able and willing to provide informed consent and comply with protocol requirements

You may not qualify if…

• Subjects administered any high energy (>300 KeV) gamma-emitting radioisotope within five (5) physical half-lives prior to Day 1
• Ongoing treatment with any systemic therapy (e.g. ADT, antiandrogen, GnRH, LHRH agonist or antagonist) for prostate cancer
• Treatment with ADT in the past 3 months of Day 1
• Receipt of investigational therapy for prostate cancer within 60 days of Day 1
• Subjects with any medical condition or other circumstances that, in the opinion of the investigator, compromise the safety or compliance of the subject to produce reliable data or completing the study

Where it is running

• City of Hope National Medical Center — Duarte, California, United States
• Tower Urology — Los Angeles, California, United States
• University of California San Francisco - Helen Diller Cancer Center — San Francisco, California, United States
• Stanford — Stanford, California, United States
• Yale University — New Haven, Connecticut, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• University of Iowa — Iowa City, Iowa, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Washington University - Mallinckrodt Institute of Radiology — St Louis, Missouri, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Wisconsin — Madison, Wisconsin, United States
• Chu de Quebec - Universite Laval — Québec, Canada

Full record on ClinicalTrials.gov

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