The United States Veterans Affairs (VA) Health Care System has a strong history of conducting impactful oncology randomized clinical trials (RCTs). We developed a phase II/III RCT to test the use of metastasis-directed therapy in Veterans with oligometastatic prostate cancer (OMPC)-the first VA RCT in OMPC that leverages novel imaging and advanced radiotherapy techniques. To accomplish this, we developed a clinical trial network to conduct the study. In this manuscript, we describe several challenges we encountered in study development/conduct and our strategies to address them, with the goal of helping investigators establish robust study networks to conduct clinical trials. In the study start-up, we encountered challenges in timely site activation, and leveraged project management to maximize efficiency. Additionally, there were several changes in the clinical paradigms in imaging and treatment that led to protocol amendments to ensure maximum equipoise, recruitment, and impact of the study. Specifically, we amended the trial to add de novo OMPC patients (from initially only recurrent OMPC) and expanded the study to allow up to 10 metastases (from initially five). Finally, in order to maintain local study team engagement, we developed initiatives to maximize collaboration and add value to the overall clinical program through study participation.
Current oncology (Toronto, Ont.). 2024 Aug 21*** epublish ***
Abhishek A Solanki, Kevin Zheng, Alicia N Skipworth, Lisa M Robin, Ryan F Leparski, Elizabeth Henry, Matthew Rettig, Joseph K Salama, Timothy Ritter, Jeffrey Jones, Marcus Quek, Michael Chang, Alec M Block, James S Welsh, Aryavarta Kumar, Hann-Hsiang Chao, Albert C Chen, Ronald Shapiro, Rhonda L Bitting, Robert Kwon, William Stross, Lindsay Puckett, Yu-Ning Wong, Nicholas G Nickols, Kimberly Carlson, VA STARPORT Investigators Group
Edward Hines Jr. VA Hospital, Hines, IL 60141, USA., Cooperative Studies Program, VA Connecticut Healthcare System, West Haven, CT 06515, USA., Cooperative Studies Program, Edward Hines Jr. VA Hospital, Hines, IL 60141, USA., VA Greater Los Angeles Healthcare System, Los Angeles, CA 90073, USA., Durham VA Medical Center, Durham, NC 27705, USA., Richmond VA Medical Center, Richmond, VA 23249, USA., Michael E. DeBakey VA Medical Center, Houston, TX 77030, USA., Louis Stokes Cleveland VA Medical Center, Cleveland, OH 44106, USA., Richard L. Roudebush VA Medical Center, Indianapolis, IN 46202, USA., VA Long Beach Healthcare System, Long Beach, CA 90822, USA., Minneapolis VA Medical Center, Minneapolis, MN 55417, USA., Clement J. Zablocki VA Medical Center, Milwaukee, WI 53295, USA., Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA 19104, USA.