DENVER, Aug. 12, 2020 /PRNewswire/ -- MANA RBM and CUSP announce the randomization of the first subject in ESCALATE, A Phase III Randomized Study Comparing Enzalutamide or Darolutamide with Radium-223 vs Enzalutamide or Darolutamide with Placebo and the Effect upon Symptomatic Skeletal Event-Free Survival for mCRPC Patients, clinicaltrials.gov #NCT04237584].
Enrolment is planned for patients with metastatic prostate cancer which progressed with initial androgen deprivation therapy (mCRPC). Patients will be randomized to either darolutamide or enzalutamide, focusing upon detailed safety and tolerability analyses, in addition to clinical outcome assessments, with subsequent addition of radium-223 dichloride or placebo. This phase 3 trial plans to accrue approximately 500 subjects.
Dr. Neal Shore of Carolina Urologic Research Center, the Principal Investigator for the trial, designed the treatment paradigm in collaboration with Dr. Oliver Sartor, Professor at Tulane University School of Medicine. Dr. Shore stated, "The eventual outcome analytics may potentially enhance treatment options for mCRPC as patients as well as augment our understanding of advanced prostate cancer sequencing strategies. We are honored to have enrolled and randomized the first subject and are very appreciative of our trial site organization's ongoing commitment."
The CUSP Group is a Clinical Research Consortium composed of 24 large tertiary uro-oncology community research practices. As a trial management organization, CUSP supported ESCALATE protocol development, constituted the study network and conducted preliminary protocol education as well as rapid budget and CTA harmonization. As a research advocacy group, CUSP endeavors to bring scientifically interesting and operationally well-crafted trials to its members. These CUSP consortium exclusive studies allow for the early adoption and rapid diffusion of new technologies, medicines, and procedures into the affiliated clinical practices. Additionally, as part of this CUSP advocacy mission, Thomas Paivanas, Executive Director of CUSP, said, "We are excited to be testing a complete digital research ePlatform developed by our colleagues at MANA RBM to conduct overall trial management and remote oversite. These endeavors promise to provide an integrated, potentially paperless system that works well for our research sites, saving them time and enhancing quality."
MANA RBM, the study sponsor, is a clinical trials institute and research laboratory. It is a leader in designing, testing, publishing, and pioneering enhanced methods for remote trial management and quality risk- based monitoring oversight for clinical trials. "For nearly a decade, we have continually enhanced our systems for remote trial management. We are excited to work with Drs. Shore and Sartor in collaboration with the CUSP Clinical Research Consortium to conduct this critical study and to enhance the way sites are able to conduct clinical research," said Penelope Manasco, M.D., CEO of MANA RBM. "We are also excited to announce another unique aspect of this Trial - the launch of REACHERTM. It is the first clinical trial quality management system, based on patent pending software, designed to automatically identify critical, protocol specific errors and systematic errors in near real time across all of the myriad of clinical trial technology systems."
SOURCE MANA RBM