CERSI Collaborators: Yale University: Michael Leapman, MD, MHS (PI); Joseph Ross, MD, MHS (CERSI PI); Molly Jeffery, PhD (CERSI PI); Cary Gross, MD (Co-I); Lawrence Saperstein, MD (Co-I); R. Jeffrey Karnes, MD (Co-I); Natalia Kunst, PhD (Co-I); Xiaomei Ma, PhD (Co-I); Shi-Yi Wang, MD, PhD (Co-I); Jessica Long, MPH (Co-I); Preston Sprenkle, MD (Co-I); Isaac Kim, MD, PhD, MBA (Co-I); Michelle Bernabeo (PM)

FDA Collaborators: Catherine Lerro, MPH, PhD; Paul Kluetz, MD; Jaleh Fallah, MD; Daniel Suzman, MD; Jianjin Xu, PhD

Project Start Date: October 12, 2022

Regulatory Science Challenge

New imaging tools have the potential to change cancer management in ways that are not yet well understood. Recently, imaging tools such as positron emission tomography (PET) scans, have been developed to diagnose and visualize several types of cancer, and these tests will change the way that patients are monitored and treated with the potential to improve the outcome of their disease. Molecular imaging is particularly promising for prostate cancer, the second leading cause of cancer death in males, and a disease in which precisely locating areas of spread (metastasis) has previously been difficult. One of the most promising new PET scans identifies tumors via a protein they express called Prostate Specific Membrane Antigen (PSMA). PSMA-PET appears to be more accurate at finding small amounts of prostate cancer in the body as compared with standard tests such as computerized tomography (CT scans) and bone scans.

The effects of increased use of PSMA-PET in patients with prostate cancer are not known. No studies have yet examined the long-term outcomes of patients after PSMA-PET imaging to determine whether these scans help patients live longer or reduce the burden from their disease and its treatment. In addition, PSMA-PET, like any diagnostic test, is imperfect and there are risks of missing or incorrectly identifying areas as cancerous. Another potential consequence is that patients may begin treatments with side effects earlier, which would impact their quality of life. In this study, investigators will examine how PSMA-PET testing affects (1) prostate cancer staging (2) prostate cancer monitoring and treatment, and (3) patient outcomes after PSMA-PET directed treatment.

Project Description and Goals

The overarching objective of this project is to evaluate the impact of widespread use of PSMA-PET imaging for patients with prostate cancer. In the first phase of this study, investigators will evaluate the short-term clinical decisions that occur after PSMA-PET imaging in prostate cancer in patients who have previously undergone PSMA-PET imaging. In the second phase of this study, investigators will create decision models to estimate the long-term effects of PSMA-PET imaging for patients, focusing on how testing may impact length of treatment, side-effects, quality of life, and overall survival.