A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Apalutamide Plus Androgen Deprivation Therapy (ADT) Versus ADT in Subjects With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

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Record identity and dates

Source

ClinicalTrials.gov

Source record ID

NCT02489318

Title field or adapter rule

{'original_value': 'A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Apalutamide Plus Androgen Deprivation Therapy (ADT) Versus ADT in Subjects With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)', 'source_field': 'protocolSection.identificationModule.officialTitle'}

Ingested At

2026-11-07T01:02:19.460394+00:00

Published At

2022-01-18T00:00:00+00:00

Record Updated At

2026-11-04

Results Posted At

2022-01-18

Source Retrieved At

2026-11-07T01:02:18.192178+00:00

Timestamp Basis

ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter

Date limitation

ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter

Fields recorded by this source

protocolSection.conditionsModule.conditions

["Prostate Cancer"]

protocolSection.statusModule.lastUpdatePostDateStruct

{"date": "2026-11-04", "type": "ACTUAL"}

protocolSection.identificationModule.nctId

"NCT02489318"

protocolSection.identificationModule.officialTitle

"A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Apalutamide Plus Androgen Deprivation Therapy (ADT) Versus ADT in Subjects With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)"

protocolSection.statusModule.overallStatus

"ACTIVE_NOT_RECRUITING"

protocolSection.designModule.phases

["PHASE3"]

protocolSection.statusModule.resultsFirstPostDateStruct

{"date": "2022-01-18", "type": "ACTUAL"}

Study condition terms

• Prostate Cancer (protocolSection.conditionsModule.conditions)

Interventions recorded in this study

• {'armGroupLabels': ['Apalutamide plus ADT'], 'description': 'Participants will receive apalutamide 240 mg (4 x 60 mg) tablets orally once daily in each 28 day treatment cycles.', 'name': 'Apalutamide', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['Placebo plus ADT'], 'description': 'Participants will receive Placebo orally once daily in each 28 day treatment cycles.', 'name': 'Placebo', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['Apalutamide plus ADT', 'Placebo plus ADT'], 'description': 'All participants will receive and remain on a stable regimen of ADT (gonadotropin releasing hormone analog \\[GnRHa\\] or surgical castration). The choice of the GnRHa (agonist or antagonist) will be at discretion of the Investigator. Dosing (dose and frequency of administration) will be consistent with the prescribing information.', 'name': 'Androgen Deprivation Therapy (ADT)', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])

An intervention appearing in a study record does not establish an effect or an approved use.

Drug names recorded in this source

• Apalutamide (protocolSection.armsInterventionsModule.interventions[].name)
• Placebo (protocolSection.armsInterventionsModule.interventions[].name)
• Androgen Deprivation Therapy (ADT) (protocolSection.armsInterventionsModule.interventions[].name)

A recorded drug name is not by itself an indication or a condition-specific relationship.

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