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

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.

I'm interested

Male
18 years and over
This study is NOT accepting healthy volunteers
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

Other: ADT, Drug: Darolutamide (BAY1841788, Nubeqa), Other: Placebo matching darolutamide

Cancer

Prostate Cancer, Recurrent Prostate Cancer, Clinics and Surgery Center (CSC)

Emmanuel Antonarakis - anton401@umn.edu
Emmanuel Antonarakis
PHASE3
SITE00001890
See this study on ClinicalTrials.gov

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