Participant flow

Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer · Source last updated 2025-12-04

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug. ADT administration started ≤12 weeks before randomization.

   id

   FG000

   title

   Darolutamide (BAY1841788) + Docetaxel

2. description

   Participants received matching placebo to darolutamide in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug. ADT administration started ≤12 weeks before randomization.

   id

   FG001

   title

   Placebo + Docetaxel

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Protocol Violation

   2. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         6

      type

      Physician Decision

   3. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         2

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         11

      2. group Id

         FG001

         num Subjects

         6

      type

      Additional primary malignancy

   5. reasons

      1. group Id

         FG000

         num Subjects

         14

      2. group Id

         FG001

         num Subjects

         12

      type

      Non-compliance with study drug

   6. reasons

      1. group Id

         FG000

         num Subjects

         24

      2. group Id

         FG001

         num Subjects

         26

      type

      Adverse event associated with clinical disease progression

   7. reasons

      1. group Id

         FG000

         num Subjects

         26

      2. group Id

         FG001

         num Subjects

         40

      type

      Withdrawal by Subject

   8. reasons

      1. group Id

         FG000

         num Subjects

         131

      2. group Id

         FG001

         num Subjects

         276

      type

      Progressive disease - clinical progression

   9. reasons

      1. group Id

         FG000

         num Subjects

         90

      2. group Id

         FG001

         num Subjects

         133

      type

      Progressive disease - radiological progression

   10. reasons

       1. group Id

          FG000

          num Subjects

          49

       2. group Id

          FG001

          num Subjects

          27

       type

       Adverse event not associated with clinical disease progression

   11. reasons

       1. group Id

          FG000

          num Subjects

          9

       2. group Id

          FG001

          num Subjects

          5

       type

       Death

   12. reasons

       1. group Id

          FG000

          num Subjects

          287

       2. group Id

          FG001

          num Subjects

          118

       type

       Other

   Show more (12 of 13)

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         651

      2. group Id

         FG001

         num Subjects

         654

      comment

      Randomized: 1306 patients were randomized. One patient was excluded from analysis due to a GCP violation

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         651

      2. group Id

         FG001

         num Subjects

         651

      type

      Started Treatment

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      comment

      Ongoing with treatment

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         651

      2. group Id

         FG001

         num Subjects

         654

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

1306 were randomly assigned in a 1:1 ratio to study treatment and 1305 were considered valid for efficacy analyses. A total of 1302 participants started treatment and were included to safety analyses.

recruitment Details

This multinational study was conducted between 30-Nov-2016 First Participant First Visit and 11-Apr-2023 Last Participant Last Visit, in 23 countries/regions: Australia, Belgium, Brazil, Bulgaria, Canada, China, Czech Republic, Finland, France, Germany, Israel, Italy, Japan, Mexico, Netherlands, Poland, Russian Federation, South Korea, Spain, Sweden, Taiwan, UK, US

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Preserved source evidence · Not medical advice