Participant flow

Cabazitaxel Versus the Switch to Alternative AR-targeted Agent (Enzalutamide or Abiraterone) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Patients Previously Treated With Docetaxel and Who Rapidly Failed a Prior AR-targeted Agent · Source last updated 2022-05-27

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

groups

1. description

   Participants received Cabazitaxel 25 mg/m\^2 intravenous (IV) infusion for over 1 hour on Day 1 of each 3 week treatment cycle in combination with Prednisone 10 mg orally once daily and primary prophylactic granulocyte-colony stimulating factor (G-CSF) as per investigator decision, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 22 weeks).

   id

   FG000

   title

   Cabazitaxel

2. description

   Participants received either abiraterone acetate 1000 mg orally once daily from Day 1 to Day 21 of each 3 week treatment cycle in combination with prednisone 5 mg orally twice daily; or enzalutamide 160 mg orally once daily continuously from Day 1 to Day 21 of each 3 week treatment cycle, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration =12.5 weeks)

   id

   FG001

   title

   Abiraterone Acetate or Enzalutamide

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         25

      2. group Id

         FG001

         num Subjects

         11

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Poor compliance to protocol

   3. reasons

      1. group Id

         FG000

         num Subjects

         57

      2. group Id

         FG001

         num Subjects

         92

      type

      Disease progression

   4. reasons

      1. group Id

         FG000

         num Subjects

         23

      2. group Id

         FG001

         num Subjects

         5

      type

      Investigator's decision

   5. reasons

      1. group Id

         FG000

         num Subjects

         13

      2. group Id

         FG001

         num Subjects

         6

      type

      Participant's request

   6. reasons

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         9

      type

      Other reason

   7. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         2

      type

      Randomized and not treated

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         129

      2. group Id

         FG001

         num Subjects

         126

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         126

      2. group Id

         FG001

         num Subjects

         124

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         129

      2. group Id

         FG001

         num Subjects

         126

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Participants were randomized to receive either cabazitaxel or Androgen receptor (AR) targeted therapy (abiraterone or enzalutamide were assigned based on previous AR targeted treatment in which participants previously treated with abiraterone were treated with enzalutamide and vice versa due to resistance).

recruitment Details

The study was conducted at 66 active centers in 13 countries. A total of 255 participants were randomized between 09 November 2015 to 13 November 2018, out of which 250 participants received treatment with the study drug.

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Preserved source evidence · Not medical advice