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

  • Condition: Biochemically Recurrent Prostate Cancer
  • Study ID: NCT05794906
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Conference Coverage
Conference Highlights Written by Physician Scientists
Presented by Alicia K. Morgans, MD, MPH
 The 2025 ASCO annual meeting featured a prostate cancer trials in progress session and a presentation by Dr. Alicia Morgans discussing ARASTEP, a phase 3, randomized, double-blind, placebo-controlled study assessing darolutamide + ADT in patients with high-risk biochemical recurrent prostate cancer.
Reno, Nevada (UroToday.com) -- Bayer will present new data for NUBEQA® (darolutamide) in prostate cancer at the upcoming American Urological Association (AUA) Annual Meeting taking place in Las Vegas from April 26-29, 2025. These data support the potential of NUBEQA as a treatment option across the prostate cancer disease spectrum and in diverse patient populations. NUBEQA is indicated in the U.S. for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel and for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC).
Presented by Alicia K. Morgans, MD, MPH
 Alicia K. Morgans, MD, MPH, discussed ARASTEP, a phase 3, randomized, double-blind, placebo-controlled study assessing darolutamide + ADT in patients with high-risk biochemical recurrence of prostate cancer. Patients with prostate cancer treated with radiotherapy or radical prostatectomy as primary therapy may develop biochemical recurrence of prostate cancer, defined by a PSA increase with no evidence of metastases on conventional imaging.
Presented by Alex Chehrazi-Raffle, MD
Alex Chehrazi-Raffle, MD, discussing the trial design of ARASTEP, a phase 3, randomized, double-blind, placebo-controlled study assessing darolutamide + ADT in patients with high-risk biochemical recurrence of prostate cancer.
Presented by Alex Chehrazi-Raffle, MD
Alex Chehrazi-Raffle, MD, discussing the trial design of ARASTEP, a phase 3, randomized, double-blind, placebo-controlled study of darolutamide + ADT in patients with high-risk biochemical recurrence of prostate cancer. Patients with prostate cancer treated with radiotherapy or radical prostatectomy as primary therapy may develop biochemical recurrence, defined as a PSA increase without evidence of metastases on conventional imaging.
Presented by Alicia Morgans, MD, MPH
The 2023 ESMO annual meeting included a trial in progress session on prostate cancer, featuring a presentation by Dr. Alicia Morgans discussing ARASTEP, a phase 3, randomized, double-blind, placebo-controlled study assessing darolutamide + ADT in patients with high-risk biochemical recurrence of prostate cancer.