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Positron Emission Tomography using 64Cu-SAR-bisPSMA in Participants with High-Risk Prostate Cancer Prior to Radical Prostatectomy: A Prospective, Single-Arm, Multi-Center, Blinded-Review, Phase III Diagnostic Performance Study

UCI Specialty Area: Cancer
Principal Investigator: Edward Uchio
A Study On:
Prostate

Study Description

The research project is testing a new compound which may potentially detect specific cancer lesions in people with prostate cancer. The new compound is called 64Cu-SAR-bisPSMA. 64Cu-SAR-bisPSMA is an injection given in the vein (intravenous) in preparation for an imaging test that may help detect cancer. This imaging test is called positron emission tomography/computed tomography (or PET/CT scan).

Eligibility

Study candidates must meet all the following criteria to be eligible for the study:

  1. At least 18 years of age.
  2. Signed informed consent.
  3. Untreated (i.e. no therapy for PC, including no androgen deprivation therapy [ADT] of any duration), histologically confirmed adenocarcinoma of the prostate.
  4. High-risk or greater PC defined by National Comprehensive Cancer Network Guidelines Version 1.202328 (clinical stage ≥T3a, or Grade Group ≥4, or PSA >20ng/mL).
  5. Patients electing to undergo RP with PLND. 6. For patients who have partners of childbearing potential: partner and/or patient must use

a method of birth control with adequate barrier protection.

5.1.2

Study candidates who meet any of the following criteria are not to be enrolled in the study:

  1. Administration of any high energy (>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to Day 1.
  2. Known or expected hypersensitivity to 64Cu-SAR-bisPSMA or any of its components.
  3. Patients with known predominant small cell or neuroendocrine PC.
  4. History of other active malignancy within 3 years prior to Day 1, except for adequately treated non-melanoma skin cancer and superficial bladder tumors.
  5. Any serious medical condition or extenuating circumstance which the Investigator feels may interfere with the procedures or evaluations of the study.
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Privacy Policy

University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Eric Vilain, MD, PhD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

  • Please read the information below and ask questions about anything that you do not understand. A
    researcher listed above will be available to answer your questions.
  • You are being asked to participate in a clinical research potential participant database to identify
    potential clinical research studies you may be eligible for. Participation in this database is voluntary.
    You may choose to skip any question. You may refuse to participate or discontinue your involvement
    at any time without penalty or loss of benefits. You are free to withdraw from this database at any
    time. If you decide to withdraw from this database you should notify the research team
    immediately    .
  • You are eligible to participate in this study if you may be interested in participating in a research trial at UCI Health
  • We would like to interview you to learn more about your eligibility for current clinical research studies at UCI. The interview will last about 5-30 minutes, depending on the extent of your medical history.
  • Possible risks/discomforts associated with the database are hearing about potential clinical research studies that may not be of interest to you, invasion of your privacy, or a potential breach of confidentiality.
  • There are no direct benefits from participation in the database. However, this database may help inform you on clinical research studies that you may be eligible for. Participation in UCI clinical research studies help us gain important data and knowledge that may lead to improved treatment options for people with similar conditions to you in the future.
  • There are no alternative procedures available. The only alternative is not to participate in this study.
  • There is no compensation for your participation in this database.
  • There is no cost to you for participation in this database.
  • All information collected will be stored confidentially in a world-class securely-hosted application, “RealTime CTMS,” with robust data protections and encryption. This application has HIPAA compliant architecture and application rules to ensure data privacy and regulatory compliance.
  • Researchers will use your information to assess your eligibility for current and future clinical research studies at UCI. You may opt out at any time.
  • The research team, authorized UCI personnel, and regulatory entities, may have access to your study records to protect your safety and welfare.
  • While the research team will make every effort to keep your personal information confidential, it is possible that an unauthorized person might see it. We cannot guarantee total privacy.
  • Future Research Use
    Researchers will use your information to conduct this study. Once the study is done using your information, we may share them with other researchers so they can use them for other studies in the future. We will not share your name or any other private identifiable information that would let the researchers know who you are. We will not ask you for additional permission to share this de-identified information
  • Data Retention - In accordance with UC Office of the President policy, information will be retained for 10 years after the end of the calendar year in which the research is completed.
  • If, during the course of this study, significant new information becomes available that may relate to your willingness to continue to participate, this information will be provided to you by the research team listed at the top of the form.
  • If you have any comments, concerns, or questions regarding the conduct of this research please contact the researchers listed at the top of this form
  • Please contact the UCI Institutional Review Board by phone, (949) 824-8170, by e-mail at IRB@research.uci.edu or at 160 Aldrich Hall, Irvine, CA 92697-7600 if you are unable to reach the researchers listed at the top of the form and have general questions; have concerns or complaints about the research; have questions about your rights as a research subject; or have general comments or suggestions.
What is an IRB? An Institutional Review Board (IRB) is a committee made up of scientists and nonscientists. The IRB’s role is to protect the rights and welfare of human subjects involved in research. The IRB also assures that the research complies with applicable regulations, laws, and institutional policies. UCI