Dear COMPPARE team, participants, stakeholders and friends,
I am thrilled to announce that as of 2/5/21 we have reached 40% of our accrual goal! This is astonishing given the local and global challenges presented by COVID-19. We are also excited to report that 92% of our partner sites have enrolled at least one patient despite these many challenges. I am awed by the dedication displayed by our team, participating sites, patient stakeholder group, minority engagement group, and most of all our COMPPARE enrollees, to conduct research that will improve the ability of future patients to make informed decisions based on knowledge of the comparative outcomes of conventional radiation and proton therapy in prostate cancer.
On December 15th, the Patient-Centered Outcomes Research Institute (PCORI) approved an adjustment to the sample sizes of both the pragmatic and the randomized subsets within the proton therapy cohort of the COMPPARE study. A review of the statistical analysis revealed that only 600 patients were required in the embedded randomized comparison of four-week and eight-week treatment regimens to answer the question of whether the shorter regimen was statistically non-inferior (equivalent) to the longer course of treatment rather than the original goal of 900. Therefore, the accrual goal for the embedded randomized controlled trial within the proton cohort is now 600 and the goal for the pragmatic (non-randomized) portion of the proton cohort is now 900 to maintain the overall proton cohort size of 1500. Once 900 patients are enrolled in the pragmatic group, subsequent enrollment of proton therapy patients will be limited to the randomized group until the goal of 600 randomized patients is reached. We believe this solution will both shorten the time needed to complete patient enrollment into the randomized trial and improve its feasibility.
We are hopeful and expectant that in the coming months, as vaccines are rolled out across the country, our accrual rate will return to the pre-COVID rate so that accrual will be completed as quickly as feasible to permit data analyses and answers as soon as possible. Once again, I want to thank all of you for your support, your hard work, and your shared vision to provide the best information to patients making treatment decisions based by conducting COMPPARE, a prospective controlled comparison of real-world outcomes between two types of radiation therapy for prostate cancer.
To learn more about the COMPPARE study, visit https://comppare.org/about/study-details/.
In good health,
Nancy Mendenhall, MD
COMPPARE Principal Investigator