Phase 3 study of darolutamide plus ADT compared with ADT in high-risk BCR

• Research type

  Research Study

• Full title

  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

• IRAS ID

  1007282

• Contact name

  Michael Devoy

• Contact email

  clinical-trials-contact@bayer.com

• Sponsor organisation

  Bayer Consumer Care AG

• Eudract number

  2022-000793-26

• Research summary

  Up to 50% of patients with prostate cancer develop biochemical recurrence (BCR) after primary therapy defined by rising prostate-specific antigen (PSA) with no evidence of metastatic disease by conventional imaging (CI). Patients with BCR are at an increased risk of metastasis the treatment of metastatic prostate cancer is palliative. Prostate-specific membrane antigen positron emission tomography/computed tomography(PSMA PET/CT) represents a new and more sensitive imaging method compared with CI that may allow for a more effective selection of therapies. Currently, there is no evidence of an optimal treatment for patients who do not have metastatic disease by CI even if there is evidence of metastatic disease by PSMA PET/CT. This study will address this unmet need and includes high-risk patients without radiographic evidence of metastases by CI who have PSMA PET/CT positive prostate cancer lesions. The patient population of this study is a high-risk BCR population, having exhausted all options of local therapies with curative intent.
  Darolutamide is an androgen receptor inhibitor, which has demonstrated a significant clinical benefit in extending metastasis-free survival and prolonging overall survival (OS), with a favorable safety profile in patients with non-metastatic castration-resistant prostate cancer when added to ADT. Recently darolutamide plus ADT and docetaxel significantly improved OS by lowering the risk of death by 32.5% compared with placebo and docetaxel in patients with metastatic hormone-sensitive prostate cancer with a favorable safety profile and no cumulative toxicity. This randomised, double-blind, placebo-controlled Phase 3 study will evaluate if darolutamide plus ADT given for 24 months provides superior efficacy compared with 24 months of placebo plus ADT. Approx. 750 study participants will be randomly assigned in a 1:1 ratio to receive either Darolutamide 600 mg twice daily with food or Placebo darolutamide matched tablets in appearance.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  23/NW/0128

• Date of REC Opinion

  18 Aug 2023

• REC opinion

  Further Information Favourable Opinion