Status:
UNKNOWN
64Cu-SAR-bisPSMA Positron Emission Tomography of Patients With Known or Suspected Prostate Cancer
Lead Sponsor:
Luke Nordquist, MD
Collaborating Sponsors:
Clarity Pharmaceuticals
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This research project is testing a new compound which may potentially detect specific cancer lesions in men with prostate cancer.
Detailed Description
This is a prospective, non-randomized, single arm, single center, open-label study of 64Cu-SAR-bisPSMA PET in patients with known or suspected prostate cancer (PC). Patients will be screened during a...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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.
Key Trial Info
Start Date :
March 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2023
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05286840
Start Date
March 28 2022
End Date
September 30 2023
Last Update
March 18 2022
Active Locations (1)
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1
GU Research Network
Omaha, Nebraska, United States, 68130