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NCT02799602 · OUTCOME

Symptomatic Skeletal Event Free Survival (SSE-FS) - Month

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.

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
From randomization of the first participant to the first occurrence of an SSE event or death from any cause, whichever occurred first up to 25 OCT 2021 cut-off date approximately 59 months

What was measured

Symptomatic skeletal event-free survival (SSE-FS) was defined as the time from randomization to the first occurrence of an SSE or death from any cause, whichever occurred first. Treatment period: until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance. Active follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data. NA = Value cannot be estimated due to censored data

Groups in this outcome

Darolutamide (BAY1841788) + Docetaxel

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.

Placebo + Docetaxel

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Darolutamide (BAY1841788) + Docetaxel651
Placebo + Docetaxel654

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Darolutamide (BAY1841788) + Docetaxel51.2Not reported47.2NANA = Value cannot be estimated due to censored data
Placebo + Docetaxel39.7Not reported36.042.3Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.516
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.718
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Hazard ratio \< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).
    non Inferiority Type
    SUPERIORITY
    other Analysis Description
    One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).
    p Value
    <0.0001
    p Value Comment
    One-sided p-value.
    param Type
    Hazard Ratio (HR)
    param Value
    0.609
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.516
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.718
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Hazard ratio \< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).
    non Inferiority Type
    SUPERIORITY
    other Analysis Description
    One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).
    p Value
    <0.0001
    p Value Comment
    One-sided p-value.
    param Type
    Hazard Ratio (HR)
    param Value
    0.609
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        NA = Value cannot be estimated due to censored data
        group Id
        OG000
        lower Limit
        47.2
        upper Limit
        NA
        value
        51.2
      2. group Id
        OG001
        lower Limit
        36.0
        upper Limit
        42.3
        value
        39.7
denoms
  1. counts
    1. group Id
      OG000
      value
      651
    2. group Id
      OG001
      value
      654
    units
    Participants
description
Symptomatic skeletal event-free survival (SSE-FS) was defined as the time from randomization to the first occurrence of an SSE or death from any cause, whichever occurred first. Treatment period: until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance. Active follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data. NA = Value cannot be estimated due to censored data
dispersion Type
95% Confidence Interval
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
    OG000
    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
    OG001
    title
    Placebo + Docetaxel
param Type
MEDIAN
reporting Status
POSTED
time Frame
From randomization of the first participant to the first occurrence of an SSE event or death from any cause, whichever occurred first up to 25 OCT 2021 cut-off date approximately 59 months
title
Symptomatic Skeletal Event Free Survival (SSE-FS) - Month
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice