CompletedPhase 3

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

United States208 participantsStarted 2018-11-27

Plain-language summary

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.

Who can participate

Age range18 Years

SexMALE

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Inclusion criteria

✓. 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)

What they're measuring

Correct Localization Rate (CLR)

Timeframe: Within 60 days following 18F-DCFPyL PET/CT imaging.

Trial details

NCT IDNCT03739684

SponsorProgenics Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-08-29

Results submitted2021-05-16

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