Listen to Veronica Dell’Acqua, MD speaking about our Hypothesis Testing Program (HTP) in this video.
What is the Hypothesis Testing Program?
Our current focus is on soliciting proposals for prospective hypothesis-testing clinical trials pertaining to Unity Treatments, with a specific emphasis on evaluating a novel treatment paradigm. The primary aim is to generate essential clinical evidence that substantiates the efficacy and utility of Unity. The overarching objective is to facilitate multi-institutional clinical prospective studies spanning various phases of development.
Within the current landscape, our attention is dedicated to technical development, standardizations, and safety considerations, all of which undergo continual refinement. Recognizing the imperative need for a clinical hypothesis testing program, this initiative serves as the catalyst to propel scientific advancements and elevate the standard of care. Our commitment is rooted in a meticulous selection process, commencing with the Tumor Site Group (TSG). Subsequently, proposals undergo scrutiny by the Clinical Steering Committee (CSC), followed by presentation at the consortium meeting. External reviewers then critically evaluate the proposals, culminating in a reevaluation by the CSC before the final announcement.
This comprehensive approach ensures that Unity Treatments adhere to the highest standards of scientific scrutiny, fostering innovation and ushering in a new era of care.
Our Current Hypothesis Testing Programs
We are currently running two Hypothesis Testing Programs (HTP), the HTP 1 and HTP 2 programs.
Destination 2 (HTP 1)
HTP1, named as “Destination 2,” centers on de-escalated prostate stereotactic body radiation therapy (SBRT) studies. Primary investigators, including Alison Tree, Danny Vesprini, and Uulke van der Heide, lead this multicenter randomized Phase II trial targeting localized prostate cancer. All radiotherapy interventions are conducted on the MR-Linac platform with daily adaptation techniques.
MARS (HTP 2)
MARS focuses on rectal cancer, specifically “MR-guided online adaptive dose-escalated radiotherapy for organ preservation.” This project is tailored for histologically confirmed rectal cancer cases meeting specific criteria, such as location, clinical tumor stages, lymph node involvement, distant metastasis, mesorectal fascia status, non-circumferential growth, and maximum longitudinal tumor extension.
The primary research question guiding MARS is whether organ preservation can be achieved in the majority of rectal tumor patients through online adaptive MR-guided dose escalation. This critical inquiry not only underscores the clinical significance of the project but also sets the stage for potential advancements in rectal cancer treatment.
A secondary research question explores the role of diffusion-weighted imaging on the Unity platform. Can this imaging modality identify patients less likely to achieve organ preservation, signaling the need for higher doses? This dual-pronged approach underscores the comprehensive nature of our research, striving not only for effective treatments but also for personalized strategies based on advanced imaging techniques. As we stand at this juncture, the ongoing HTP1 and HTP2 initiatives embody our commitment to advancing the frontiers of oncological research and treatment modalities.