Participant flow

A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC · Source last updated 2026-08-31

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

groups

1. description

   Participants received matching placebo (4 tablets) orally once daily (qd) along with ADT (gonadotropin releasing hormone analog \[GnRHa\] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. In the event of a positive result at interim or final analysis participants in treatment phase had opportunity to receive Apalutamide +ADT. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.

   id

   FG000

   title

   Placebo + Androgen Deprivation Therapy (ADT)

2. description

   Participants received JNJ-56021927 (apalutamide) 240 milligrams (mg) (4\*60 mg tablets) orally qd along with ADT (gonadotropin releasing hormone analog \[GnRHa\] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.

   id

   FG001

   title

   Apalutamide + ADT

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Withdrawal by Subject

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         527

      2. group Id

         FG001

         num Subjects

         525

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         527

      2. group Id

         FG001

         num Subjects

         524

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      NOT COMPLETED

   title

   Randomized

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         19

      2. group Id

         FG001

         num Subjects

         62

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         13

      2. group Id

         FG001

         num Subjects

         11

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         6

      type

      Physician Decision

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         2

      type

      Protocol Violation

   5. reasons

      1. group Id

         FG000

         num Subjects

         37

      2. group Id

         FG001

         num Subjects

         36

      type

      Withdrawal by Subject

   6. reasons

      1. group Id

         FG000

         num Subjects

         245

      2. group Id

         FG001

         num Subjects

         138

      type

      Other: Progressive Disease

   7. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      type

      Other

   8. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         267

      type

      Ongoing

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         527

      2. group Id

         FG001

         num Subjects

         524

      type

      STARTED

   2. achievements

      1. comment

         Participants crossed over from placebo to apalutamide after positive results at interim analysis.

         group Id

         FG000

         num Subjects

         208

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         319

      2. group Id

         FG001

         num Subjects

         524

      type

      NOT COMPLETED

   title

   Treated

pre Assignment Details

Per protocol, 208 participants randomized to receive placebo+ADT were switched over to receive apalutamide+ADT after interim analysis and unblinding. Randomized treatment disposition has been reported in participant flow. Response/progression that occurred during a non-randomized switch-over to apalutamide+ADT were not counted towards efficacy outcome measures.

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Preserved source evidence · Not medical advice