StudyFinder
A randomized, double-blind, placebo-controlled Phase 3 study of darolutamide plus androgen deprivation therapy (ADT) compared with placebo plus ADT in patients with high-risk biochemical recurrence (BCR) of prostate cancer
Status: Recruiting
ADT is a systemic therapy called hormone therapy which reduces the androgen hormone (testosterone) levels to prevent prostate cancer cells from growing. This study is being done to learn more about a new drug called darolutamide given in combination with ADT for prostate cancer.
Sex: Male
Age Group: 18 years and over
Inclusion Criteria:
• diagnosis of adenocarcinoma of prostate
• treated with surgery and/or radiation therapy
• Serum testosterone 150 ng/dL or more
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:
• small cell, ductal or 50% or more component of neuroendocrine carcinoma of the prostate
• brain metastasis
• any other type of cancer (other than adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) within 5 years
• study staff will review
Conditions:
Cancer
Keywords:
Prostate Cancer, Recurrent Prostate Cancer, Clinics and Surgery Center (CSC)
Study Contact: Emmanuel Antonarakis - anton401@umn.edu
Principal Investigator: Emmanuel Antonarakis
Phase: PHASE3
IRB Number: SITE00001890
See this study on ClinicalTrials.gov