CompletedPhase 3

Copper Cu 64 PSMA I&T PET Imaging in Men With Suspected Recurrence of Prostate Cancer

United States235 participantsStarted 2024-04-01

Plain-language summary

This is a prospective, open-label Phase 3 study to evaluate copper Cu 64 PSMA I\&T injection for PET/CT imaging in patients with recurrent prostate cancer after radical prostatectomy or radiation therapy.

Who can participate

Age range18 Years

SexMALE

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Inclusion criteria

✓. Prior radical prostatectomy: PSA greater than or equal to 0.2 ng/mL followed by subsequent confirmatory PSA value greater than or equal to 0.2 ng/mL or
✓. Prior radiation therapy: 2 ng/mL rise in PSA over post-treatment nadir.

What they're measuring

Patient-Level Correct Detection Rate (CDR)

Timeframe: 4 hours

Region-Level Correct Localization Rate (CLR)

Timeframe: 4 hours

Trial details

NCT IDNCT06235099

SponsorCurium US LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-02-18

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