General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT05059236

Background Information

This study is being done to find out if an investigational drug, darolutamide, in combination with androgen deprivation therapy (ADT) helps treat prostate cancer better than ADT alone. The purpose of this study is to assess the effectiveness and safety of darolutamide in treating metastatic hormone sensitive prostate cancer.

Offered At

Inova Schar Cancer Institute
A department of Inova Fairfax Hospital
8081 Innovation Park Dr.
Fairfax, VA 22031

Eligibility Information

  • 18 years of age or older
  • Histologically or cytologically confirmed adenocarcinoma of the prostate
  • Confirmed metastatic disease
  • Patient must have undergone initial cholecystectomy within 12 weeks prior to randomization

Prior adjuvant or neoadjuvant hormonal therapy allowed provided the following criteria are met:

  • Therapy was discontinued ≥ 12 months ago AND there was a clinical state without evidence of disease at least 12 months after completing adjuvant or neoadjuvant hormonal therapy, as defined by 1 of the following:
    • PSA < 0.1 ng/mL after prostatectomy plus hormonal therapy
    • PSA < 0.5 ng/mL and has not doubled above nadir after radiotherapy plus hormonal therapy
  • Therapy lasted no more than 24 months
  • Additional eligibility in protocol

Ineligibility Information

  • Pathological finding consistent with small cell, or neuroendocrine carcinoma of the prostate
  • Active cardiac disease defined as having had any of the following within 6 months prior to start of treatment: myocardial infarction, severe/unstable angina pectoris, congestive heart failure, hospitalization for any cardiac event, including conduction abnormalities
  • Note: Relugolix is not permitted as ADT in this study • Known brain/ leptomeningeal metastases
  • Participants with prior chemotherapy in the adjuvant or neoadjuvant setting
  • Inability to swallow oral medications
  • Additional ineligibility in protocol

For additional information please go to: https://clinicaltrials.gov/ct2/show/NCT05059236