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A research study coordinated by the American College of Radiology Imaging Network (ACRIN)

Consent for Research Study A study using 18 F-Fluoride for prostate cancer patients currently enrolled in Dr. Febbo’s “Genomic Guided Therapy” study. A research study coordinated by the American College of Radiology Imaging Network (ACRIN).

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A research study coordinated by the American College of Radiology Imaging Network (ACRIN)

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  1. Consent for Research StudyA study using 18F-Fluoride for prostate cancer patients currently enrolled in Dr. Febbo’s “Genomic Guided Therapy” study A research study coordinated by the American College of Radiology Imaging Network (ACRIN)

  2. The study’s main goal is to learn if the images provided by a PET scan using 18F-fluoride can help doctors determine any changes the dasatinib is having on bone metabolism and blood flow. The ACRIN trial will enroll 24 participants who are receiving dasatinib in Dr. Febbo’s study Purpose of the Study Research Protocol ACRIN 6687

  3. If you agree to take part in this study, you will have the following procedures: Two (2) PET scans with 18F-fluoride given through an IV. You will have one (1) 18F-fluoride PET scan within 7 days before starting treatment with dasatinib for your prostate cancer. You will have one (1) 18F-fluoride PET scan approximately 12 weeks after you have your first dasatinib treatment Participation Requirements Research Protocol ACRIN 6687

  4. You will be involved with this study’s imaging procedures for about 16 to 18 weeks. Each PET imaging visit will require about two (2) to three (3) hours of your time. Study doctors will review your medical records for up to 5 years, to compare the results of the PET scan with the course of your cancer. Participation Requirements Research Protocol ACRIN 6687

  5. PET is a nuclear medicine imaging scan that produces 3-D images (pictures) that provide information about cell function and show the difference between healthy tissue and diseased tissue. 18F-fluoride is a new tracer used during a PET scan that is being evaluated to help doctors learn how the drug dasatinib changes your bone cancer and your healthy bone as well 18F-fluoride PET (Positron Emission Tomography) Research Protocol ACRIN 6687

  6. This study may be stopped at any time by your study doctor, ACRIN, FDA, and/or NCI without your consent should: Your health or safety be at risk; The study drug will no longer be available; An administrative decision made by the study doctor, ACRIN, FDA, and/or NCI. Participation Requirements Research Protocol ACRIN 6687

  7. Benefits of Participation Although this study is not designed to be of direct medical benefit to you, your participation could: Give you the satisfaction of being part of an effort with the potential to benefit other patients with prostate cancer in the future Help doctors determine the best way to evaluate people with prostate cancerthat has spread to the bone Research Protocol ACRIN 6687

  8. The doctors and nurses will provide a supportive environment for participants and will: assist in scheduling scans, answer procedure questions, and make your involvement as comfortable as possible. Support During Participation

  9. Risks Associated With Participation If you choose to participate in this study, you may be at risk for side effects. Side effects from your scan are rare; however, any side effects you should experience are likely to go away shortly after the imaging scan is stopped and IV catheter is removed. Other drugs may be given to make side effects less serious and uncomfortable. Research Protocol ACRIN 6687

  10. Patient Confidentiality Every effort will be made to keep your personal information confidential. Confidential copies of your study records will be kept at the hospital or medical center where you receive your scan. Study data and images sent to the American College of Radiology Imaging Network (ACRIN) in Philadelphia, PA will first have the study participant’s information removed. Research Protocol ACRIN 6687

  11. Patient Confidentiality cont. Organizations such as the following may inspect or copy your records for quality assurance: Food and Drug Administration (FDA) National Cancer Institute (NCI) Institutional Review Board (IRB) ACRIN Statistical Center ACRIN Bristol Myers Squib Research Protocol ACRIN 6687

  12. Taking part in this study will not lead to added costs to you or your insurance company Please speak with your doctor or research associate about specific details regarding reimbursement, any added costs, or insurance problems Cost of Participation Research Protocol ACRIN 6687

  13. If you have questions… Regarding the research study: Contact the study doctor or research associate Regarding patients’ rights: Ask your study doctor or research associate who you should contact at their Institutional Review Board (IRB) Regarding general cancer research: Call the NCI’s Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). Research Protocol ACRIN 6687

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