Neal Shore, MD at the Carolina Urologic Research Center discusses the ESCALATE Trial Potential Enhancement of Prostate Cancer Treatment Options: First Patient Randomized in Phase III Trial
A Phase III Randomized Analysis Comparing Enzalutamide or Darolutamide with Radium-223 vs Enzalutamide or Darolutamide with Placebo and the Effect on Symptomatic Skeletal Event-Free Survival in mCRPC Patients, clinicaltrials.gov # NCT04237584, MANA RBM and CUSP report the randomization of the first participant in ESCALATE.
For patients with metastatic prostate cancer that has progressed with initial androgen deprivation therapy (mCRPC), enrollment is scheduled. In addition to clinical outcome tests, patients will be randomized to either darolutamide or enzalutamide, based on comprehensive safety and tolerability studies, with subsequent addition of radium-223 dichloride or placebo. Approximately 500 subjects are scheduled for this Phase 3 experiment.
The CUSP Group is a Clinical Research Collaboration consisting of 24 large community research practices in tertiary uro-oncology. CUSP sponsored the creation of the ESCALATE protocol, developed the study network and performed preliminary protocol education as well as rapid budget and CTA harmonization as a trial management organization. CUSP aims to bring scientifically interesting and operationally well-crafted trials to its participants as a science advocacy organization. These exclusive studies of the CUSP consortium allow the early adoption and rapid diffusion into the affiliated clinical practices of new technologies, medicines, and procedures.