PRISM

PRISM is a study about the patient experience with PET imaging and will be enrolling those who undergo their first PSMA-PET scan for a diagnosis of prostate cancer.

PRISM stands for: Optimizing PRostate Cancer Care: Integrating Risks, BenefitS, and Patient Experiences in the New Era of Molecular Imaging

The purpose of the PRISM study is to learn more about the patient experience with PET imaging. We hope to gain a better understanding of how PET imaging affects patients’ decision making, psychological wellbeing, and overall quality of life. We plan to use this information to gain a deeper understanding of how new forms of imaging are used in the diagnosis and decision-making process for patients with prostate cancer. The investigators aim to use this information to develop ways to improve the patient experience, the way that tests are chosen and explained by doctors, and the outcome of cancer imaging.

Prostate cancer is commonly found in men. Prostate Specific Membrane Antigen Positron Emission Tomography (PSMA-PET) scans have recently been developed to help identify prostate cancer in the body. These tests appear to improve the detection of prostate cancer, but little is known about the patient experience of PET imaging, or the treatment decisions and long-term outcomes after testing.

Your participation includes completing four short surveys (electronically or on paper) which are administered at three time points: at initial PET imaging, 3 months following PET imaging, and 12 months after PET imaging. The estimated time to complete the surveys is 15 minutes or less.

A subset of participants will also be invited to take part in confidential, in-depth audio-recorded interviews to learn more about experiences with PET imaging. These interviews would occur at the same three timepoints as the surveys described previously and may take between 30 and 60 minutes. With your permission, the interviews will be recorded and transcribed into text and confidential samples of text will be analyzed and may be used as part of educational lectures, published manuscripts, or other communications.

You are welcome to participate in the surveys but not take part in the interviews. Your name will not be used in these materials and no identifying features about you will be included in the study analysis or published materials.

Participating in this study is voluntary. Refusing to participate will involve no penalty or loss of benefits to which you are otherwise entitled (such as your health care outside the study, the payment for your health care, and your health care benefits). We encourage you to ask questions about the study to help you make the best decision for you. We are happy to speak with you without any obligations to participate.

After completing the 4 short surveys, you will be issued a pre-paid debit card with $50 on it as our thank you for taking part in the study. After completing the set of surveys at each time point, we will load an additional $50 to the bank card. A total of $150 will be administered for completion of surveys over the course of the year.

If you participate in the interview part of the study, you will be issued an additional $50, added to your pre-paid debit card, after each interview to provide payment for taking part in the interview portion of the study.

• Have a documented diagnosis for prostate cancer
• Are scheduled for your first PSMA-PET scan or have had your first PSMA-PET scan within one-month at time of enrollment
• PSMA-PET scan is not a part of a clinical trial
• Are English Speaking
• Are 18 years of age or older

We seek to enroll 300 patients through the Yale New Haven Health system who have been diagnosed with prostate cancer and are scheduled to have a PSMA-PET scan for the first time.

There are minimal risks to study participants. The potential risks include:

• Anxiety or other emotional distress when discussing a recent diagnosis of prostate cancer or matters perceived as private relating to urinary or sexual health.
• Inconvenience due to time commitment for screening, recruitment, and participation.
• Breach of confidentiality and privacy. Every effort will be made to keep your information confidential; however, this cannot be guaranteed.

This study may not benefit you personally, however we hope that the results will add to the knowledge about how PET imaging can be used to improve the lives of patients with cancer.

HIC ID: 2000037284