UnknownPhase 1/2

64Cu-SAR-bisPSMA Positron Emission Tomography of Patients With Known or Suspected Prostate Cancer

United States150 participantsStarted 2022-03-28

Plain-language summary

This research project is testing a new compound which may potentially detect specific cancer lesions in men with prostate cancer.

Age range18 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Signed an informed consent.
✓. \>18 years of age.
✓. Known diagnosis of prostate adenocarcinoma confirmed by histopathology OR patients with suspicion of prostate cancer based on elevated PSA but negative standard of care imaging and/or negative biopsy.
✓. The Eastern Cooperative Oncology (ECOG) performance status 0-2.
✓. Adequate recovery from acute toxic effects of any prior therapy.
✓. Adequate renal function (eGFR of 30 ml/min/1.73m2 or higher)

✕. Participants must not receive other investigational agents within 28 days prior to 64Cu-SAR-bisPSMA administration.
✕. Patients administered any high energy (\>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to 64Cu-SAR-bisPSMA administration.
✕. Known or expected hypersensitivity to 64Cu-SAR-bisPSMA or any of its components.
✕. Any serious medical condition or extenuating circumstance which the investigator feels may interfere with the procedures or evaluations of the study.

To assess safety of 64Cu-SAR-bisPSMA (all patients).

Timeframe: From injection of 64Cu-SAR-bisPSMA to one week following.

NCT IDNCT05286840

SponsorLuke Nordquist, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03-28

Tony Romero