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

Status unconfirmed · Phase 1/Phase 2

Conditions studied: Prostate Cancer

In brief

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

Key facts

Study ID

NCT05286840

Run by

Luke Nordquist, MD

People needed

150

Starts

2022-03-28

Expected to finish

2023-09-30

Last updated by the study team

2022-03-18

Who can join

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

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• GU Research Network — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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