The United States Veterans Affairs (VA) Health Care System is leveraging its strong history of oncology randomized clinical trials (RCTs) to conduct a phase II/III RCT evaluating metastasis-directed therapy in Veterans with oligometastatic prostate cancer (OMPC). This represents the first VA RCT in OMPC to utilize novel imaging and advanced radiotherapy techniques.
Addressing Challenges in Clinical Trial Development
Developing a clinical trial network to conduct this study presented several challenges. According to a recent publication, the study start-up faced hurdles in timely site activation. To combat this, the team implemented project management strategies to maximize efficiency. These strategies were crucial in ensuring the trial could proceed without significant delays.
Adapting to Evolving Clinical Paradigms
Changes in clinical paradigms related to imaging and treatment necessitated protocol amendments to maintain equipoise, recruitment, and the study's overall impact. Initially focused on recurrent OMPC, the trial was expanded to include de novo OMPC patients. Furthermore, the protocol was revised to allow for up to 10 metastases, an increase from the original limit of five. These changes ensured the trial remained relevant and inclusive of a broader patient population.
Maintaining Local Engagement
To ensure continued engagement from local study teams, initiatives were put in place to maximize collaboration and enhance the value of participation in the clinical program. These efforts were aimed at fostering a sense of shared purpose and investment in the study's success.
