> Our Work > The Work We Fund

2023 Bayer-PCF Darolutamide Challenge Award

Darostep: Evaluating Step Counts as a Biomarker and its Relationship on Treatment Outcomes in Vulnerable Patients with Metastatic Hormone-Sensitive Prostate Cancer on Darolutamide and Androgen Deprivation Therapy

Principal Investigators: Russell Szmulewitz, MD (The University of Chicago), Nabiel Mir, MBBS (The University of Chicago), Megan Huisingh-Scheetz, MPH, MD (The University of Chicago)

Description:

  • Prostate cancer predominantly affects older adults aged ≥ 65, but current treatments like intensified androgen deprivation therapy (ADT) often exacerbate physical and cognitive decline.
  • Darolutamide exhibits improved tolerability in fitter older adults recruited for clinical trials, but has not been studied in vulnerable older adults. Participation in drug trials often burdens vulnerable older adults with expanded monitoring requirements for an expanded set of potential treatment effects.
  • Nabiel Mir and team will conduct a novel clinical trial, DAROSTEP, to assess the effects of darolutamide + ADT on age-related outcomes in vulnerable older patients with metastatic hormone sensitive prostate cancer (mHSPC).
  • Patients will be provided with a wrist accelerometer as a non-invasive digital biomarker, to remotely monitor cancer treatment tolerability.
  • This trial will measure the impact of darolutamide + ADT on patient-reported outcomes (PROs), wrist accelerometry-determined daily step counts, physical activity, physical and cognitive function, body composition, and adverse events in vulnerable patients ≥70-years-old with mHSPC.
  • This study will be performed within a diverse array of care centers, to focus inclusion on older/minority populations who bear a heightened burden of metastatic prostate cancer development and mortality.
  • If successful, this project will determine the impact of darolutamide on health outcomes and quality of life in vulnerable older adults with mHSPC, an understudied group often overlooked in clinical trials. This information will be used to guide therapeutic decisions, improve care, and enhance outcomes of older adults with prostate cancer.
  • The study’s innovative incorporation of wrist accelerometry could also pave the way for inclusion of digital monitors in clinical trials and practice for geriatric prostate cancer patients, to remotely monitor adverse events and ultimately improve patient outcomes.

What this means to patients:  The impact of prostate cancer treatments is understudied in older, more frail patients, as they are often excluded from or overburdened by inclusion in clinical trials. Dr. Mir and team will evaluate the impact of darolutamide, a treatment with improved tolerability in fitter patients, on age-related outcomes in vulnerable older patients with mHSPC. This trial will also evaluate the ability of a wrist accelerometer to remotely monitor adverse events in patients, which could greatly increase the ability to monitor side effects in frail patients in clinical trials or undergoing real world treatment.