Listen to Veronica Dell’Acqua, MD speaking about our Hypothesis Testing Program (HTP) in this video.
What is the Hypothesis Testing Program?
We are currently seeking proposals for clinical trials to test new hypotheses about Unity Treatments, focusing on a new treatment approach. Our main goal is to gather important clinical evidence to prove the effectiveness and usefulness of Unity. We aim to support multi-institutional clinical studies at various stages of development.
Right now, we are concentrating on technical development, standardization, and safety, which are constantly being improved. We recognize the need for a clinical hypothesis testing program to drive scientific progress and improve care standards. Our selection process starts with the Tumor Site Group (TSG). Proposals are then reviewed by the Clinical Steering Committee (CSC), presented at a consortium meeting, evaluated by external reviewers, and finally re-evaluated by the CSC before the final decision is made.
This thorough process ensures that Unity Treatments meet the highest scientific standards, promoting innovation and advancing 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.
