Trial · NCT02799602
Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer
NCT02799602, Phase 3, Completed, Bayer; results first posted 2023-02-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer. Trials, record NCT02799602. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02799602
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer
- NCT number
- NCT02799602
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,306 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Metastatic Hormone-sensitive Prostate Cancer
- Interventions
- BAY1841788 / darolutamide (ODM-201), Standard ADT (androgen deprivation therapy), Docetaxel, Placebo
- First posted
- 2016-06-15
- Last updated
- 2025-12-04
- Other registries' IDs
- eudract:2015-002590-38
- Results first posted
- 2023-02-24
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | OS From Date of Randomization Until Death From Any Cause - Number of Events | From randomization of the first participant until death from any cause up to 25 OCT 2021 cut-off date 533 OS events were reached (approximate 59 months) | Overall survival (OS) was defined as the time from the date of randomization until death from any cause. Treatment period: treatment was provided for all patients, twice daily, 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. Long-term (Survival) follow-up period: After Active follow-up, patients continued to be contacted approximately every 12 weeks by phone. The end of the Survival follow-up period was defined as when the patient died, was lost to follow-up, withdrew consent, or at the end-of-study. |
| Primary | OS From Date of Randomization Until Death From Any Cause - Month | From randomization of the first participant until death from any cause up to 25 OCT 2021 cut-off date 533 OS events were reached (approximate 59 months) | Treatment period: treatment was provided for all patients, twice daily, 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. Long-term (Survival) follow-up period: After Active follow-up, patients continued to be contacted approximately every 12 weeks by phone. The end of the Survival follow-up period was defined as when the patient died, was lost to follow-up, withdrew consent, or at the end-of-study. Median, percentile and other 95% CIs were computed using Kaplan-Meier estimates. NA = Value cannot be estimated due to censored data |
| Secondary | Number of Participants With TEAEs | From the first dose of darolutamide or placebo until 30 days after the last dose of darolutamide or placebo administration up to cut-off date for the final completion analysis 11 APR 2023 (approximately 77 months) | TEAEs = Treatment-emergent adverse events, were defined as any event(s) arising or worsening after the first dose of darolutamide or placebo, until 30 days after the last dose of darolutamide or placebo administration. |
| Secondary | Time to Castration-Resistant Prostate Cancer (CRPC) - Number of Events | From randomization of the first participant to the first occurrence of an CRPC event up to 25 OCT 2021 cut-off date approximately 59 months | Time to castration-resistant prostate cancer was defined as the time from randomization to the first occurrence of one of the following events: PSA progression, Radiological progression by bone lesions, or Radiological progression by soft tissue and visceral lesions. 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. |
| Secondary | Time to Castration-Resistant Prostate Cancer (CRPC) - Month | From randomization of the first participant to the first occurrence of an CRPC event up to 25 OCT 2021 cut-off date approximately 59 months | Time to castration-resistant prostate cancer was defined as the time from randomization to the first occurrence of one of the following events: PSA progression, Radiological progression by bone lesions, or Radiological progression by soft tissue and visceral lesions. 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 |
| Secondary | Time to Pain Progression - Number of Events | From randomization of the first participant to the first occurrence of a pain progression event up to 25 OCT 2021 cut-off date approximately 59 months | Time to pain progression was defined as the time from randomization to the first date a patient experienced pain progression. Treatment period: treatment was provided for all patients, twice daily, 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. |
| Secondary | Time to Pain Progression - Month | From randomization of the first participant to the first occurrence of a pain progression event up to 25 OCT 2021 cut-off date approximately 59 months | Time to pain progression was defined as the time from randomization to the first date a patient experienced pain progression. Treatment period: treatment was provided for all patients, twice daily, 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 |
| Secondary | Symptomatic Skeletal Event Free Survival (SSE-FS) - Number of Events | 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 | 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: treatment was provided for all patients, twice daily, 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. |
| Secondary | Symptomatic Skeletal Event Free Survival (SSE-FS) - Month | 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 | 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 |
| Secondary | Time to First Symptomatic Skeletal Event (SSE) - Number of Events | From randomization of the first participant to the first occurrence of an SSE event up to 25 OCT 2021 cut-off date approximately 59 months | Time to the first SSE was defined as the time from randomization to the first occurrence of an SSE. Identical to the definition used for SSE-FS. Death was not considered as an event in this endpoint. Treatment period: treatment was provided for all patients, twice daily, 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. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | OS From Date of Randomization Until Death From Any Cause - Number of Events | From randomization of the first participant until death from any cause up to 25 OCT 2021 cut-off date 533 OS events were reached (approximate 59 months) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With TEAEs | From the first dose of darolutamide or placebo until 30 days after the last dose of darolutamide or placebo administration up to cut-off date for the final completion analysis 11 APR 2023 (approximately 77 months) | The number of patients who started treatment is presented based on the randomized treatment assignment. One patient was randomized to the placebo+docetaxel arm but received at least one dose of darolutamide. This patient was included in the darolutamide+docetaxel arm in the analysis of all safety variables. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Castration-Resistant Prostate Cancer (CRPC) - Number of Events | From randomization of the first participant to the first occurrence of an CRPC event up to 25 OCT 2021 cut-off date approximately 59 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time to Castration-Resistant Prostate Cancer (CRPC) - Month | From randomization of the first participant to the first occurrence of an CRPC event up to 25 OCT 2021 cut-off date approximately 59 months | Months | MEDIAN | |
| SECONDARY | Time to Pain Progression - Number of Events | From randomization of the first participant to the first occurrence of a pain progression event up to 25 OCT 2021 cut-off date approximately 59 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time to Pain Progression - Month | From randomization of the first participant to the first occurrence of a pain progression event up to 25 OCT 2021 cut-off date approximately 59 months | Months | MEDIAN | |
| SECONDARY | Symptomatic Skeletal Event Free Survival (SSE-FS) - Number of Events | 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 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Symptomatic Skeletal Event Free Survival (SSE-FS) - Month | 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 | Months | MEDIAN | |
| SECONDARY | Time to First Symptomatic Skeletal Event (SSE) - Number of Events | From randomization of the first participant to the first occurrence of an SSE event up to 25 OCT 2021 cut-off date approximately 59 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time to First Symptomatic Skeletal Event (SSE) - Month | From randomization of the first participant to the first occurrence of an SSE event up to 25 OCT 2021 cut-off date approximately 59 months | Months | MEDIAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group70
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| OS From Date of Randomization Until Death From Any Cause - Number of Events | Darolutamide (BAY1841788) + Docetaxel | Number of patients with event | 229 | Participants | |
| OS From Date of Randomization Until Death From Any Cause - Number of Events | Placebo + Docetaxel | Number of patients with event | 304 | Participants | |
| OS From Date of Randomization Until Death From Any Cause - Number of Events | Darolutamide (BAY1841788) + Docetaxel | Number of patients censored | 422 | Participants | |
| OS From Date of Randomization Until Death From Any Cause - Number of Events | Placebo + Docetaxel | Number of patients censored | 350 | Participants | |
| Number of Participants With TEAEs | Darolutamide (BAY1841788) + Docetaxel | Any TEAE | 649 | Participants | |
| Number of Participants With TEAEs | Placebo + Docetaxel | Any TEAE | 643 | Participants | |
| Number of Participants With TEAEs | Darolutamide (BAY1841788) + Docetaxel | TESAE | 306 | Participants | |
| Number of Participants With TEAEs | Placebo + Docetaxel | TESAE | 276 | Participants | |
| Number of Participants With TEAEs | Darolutamide (BAY1841788) + Docetaxel | TEAE leading to study drug dose modification | 172 | Participants | |
| Number of Participants With TEAEs | Placebo + Docetaxel | TEAE leading to study drug dose modification | 112 | Participants |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Darolutamide (BAY1841788) + Docetaxel | 651 | |
| Overall Study | STARTED | Placebo + Docetaxel | 654 | |
| Overall Study | Started Treatment | Darolutamide (BAY1841788) + Docetaxel | 651 | |
| Overall Study | Started Treatment | Placebo + Docetaxel | 651 | |
| Overall Study | COMPLETED | Darolutamide (BAY1841788) + Docetaxel | 0 | |
| Overall Study | COMPLETED | Placebo + Docetaxel | 0 | |
| Overall Study | NOT COMPLETED | Darolutamide (BAY1841788) + Docetaxel | 651 | |
| Overall Study | NOT COMPLETED | Placebo + Docetaxel | 654 |
Source ClinicalTrials.gov
Adverse events840
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Darolutamide (BAY1841788) + Docetaxel | 185 | 652 | 276 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo + Docetaxel | 164 | 650 | 227 |
| other | Neutropenia | Blood and lymphatic system disorders | Darolutamide (BAY1841788) + Docetaxel | 62 | 652 | 108 |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo + Docetaxel | 67 | 650 | 103 |
| other | Lacrimation increased | Eye disorders | Darolutamide (BAY1841788) + Docetaxel | 38 | 652 | 40 |
| other | Lacrimation increased | Eye disorders | Placebo + Docetaxel | 43 | 650 | 47 |
| other | Abdominal pain | Gastrointestinal disorders | Darolutamide (BAY1841788) + Docetaxel | 36 | 652 | 40 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo + Docetaxel | 37 | 650 | 40 |
| other | Constipation | Gastrointestinal disorders | Darolutamide (BAY1841788) + Docetaxel | 149 | 652 | 202 |
| other | Constipation | Gastrointestinal disorders | Placebo + Docetaxel | 132 | 650 | 162 |
1 to 10 of 840Source ClinicalTrials.gov
See all 840 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Darolutamide (BAY1841788) + Docetaxel | 231 | 652 |
| Total, all-cause mortality | Placebo + Docetaxel | 305 | 650 |
| Total, other adverse events | Darolutamide (BAY1841788) + Docetaxel | 636 | 652 |
| Total, other adverse events | Placebo + Docetaxel | 634 | 650 |
| Total, serious adverse events | Darolutamide (BAY1841788) + Docetaxel | 306 | 652 |
| Total, serious adverse events | Placebo + Docetaxel | 276 | 650 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Darolutamide (BAY1841788) + Docetaxel vs Placebo + Docetaxel: deaths from any cause | Trial comparisons |
| Darolutamide (BAY1841788) + Docetaxel vs Placebo + Docetaxel: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02799602
GET https://conductscience.org/api/trials/v1/NCT02799602/results?page=2