Clinical trial · Interventional
A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC
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)
NCT02489318CI-TRIAL-00124713TITANactive not recruitingPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 29, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260929-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine if the addition of apalutamide to ADT provides superior efficacy in improving radiographic progression-free survival (rPFS) or overall survival (OS) for participants with mHSPC.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Androgen Deprivation Therapy (ADT) | Drug | — | UNRESOLVED |
| Apalutamide | Drug | Apalutamide | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Apalutamide plus ADT
- description
- Participants will receive apalutamide 240 milligram (mg) (4X 60 mg tablets) with ADT.
- interventionNames
- Drug: Apalutamide
- Drug: Androgen Deprivation Therapy (ADT)
- type
- EXPERIMENTAL
- label
- Placebo plus ADT
- description
- Participants will receive matching Placebo with ADT.
- interventionNames
- Drug: Placebo
- Drug: Androgen Deprivation Therapy (ADT)
Primary outcomes (2)
- measure
- Radiographic Progression-free Survival (rPFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of prostate adenocarcinoma as confirmed by the investigator * Metastatic disease documented by greater than or equal to (\>=) 1 bone lesions on 99mTc bone scan. Participants with a single bone lesion must have confirmation of bone metastasis by computed tomography (CT) or magnetic resonance imaging (MRI) * Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade of 0 or 1 * Participants who received docetaxel treatment must meet the following criteria: a) Received a maximum of 6 cycles of docetaxel therapy for mHSPC; b) Received the last dose of docetaxel \<=2 months prior to randomization; c) Maintained a response to docetaxel of stable disease or better, by investigator assessment of imaging and PSA, prior to randomization * Other allowed prior treatment for mHSPC: a) Maximum of 1 course of radiation or surgical intervention; radiation therapy for metastatic lesions must be completed prior to randomization; b) Less than or equal to (\<=) 6 months of ADT prior to randomization * Allowed prior treatments for localized prostate cancer (all treatments must have been completed \>= 1 year prior to randomization) a) \<= 3 years total of ADT; b) All other forms of prior therapies including radiation therapy, prostatectomy,lymph node dissection, and systemic therapies Exclusion Criteria: * Pathological finding consistent with small cell, ductal or neuroendocrine carcinoma of the prostate * Known brain metastases * Lymph nodes as only sites of metastases * Visceral (ie, liver or lung) metastases as only sites of metastases * Other prior malignancy less than or equal to 5 years prior to randomization with the exception of squamous or basal cell skin carcinoma or non-invasive superficial bladder cancer * Prior treatment with other next generation anti-androgens or other CYP17 inhibitors, immunotherapy or radiopharmaceutical agents for prostate cancer * History of seizures or medications known to lower seizure threshold
References
Publications (1)
pubmedProvenance
- Source
- PubMed (NLM)
- Dataset
- PubMed E-utilities
- Retrieved
- Sep 13, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
Tomohiro Hori, Hiroaki Iwamoto, Takahiro Inaba et al. · Eur Urol Focus · Sep 11, 2026 · PMID 42728112 pubmed
- DERIVEDHori T, Iwamoto H, Inaba T, Nakagawa R, Kamijima T, Kano H, Makino T, Naito R, Yaegashi H, Shigehara K, Nohara T, Izumi K, Mizokami A. Association Between Castration-resistant Prostate Cancer Progression Patterns and Survival Outcomes in Metastatic Castration-sensitive Prostate Cancer: A Post Hoc Analysis of the TITAN Trial. Eur Urol Focus. 2026 Sep 11:S2405-4569(26)00149-5. doi: 10.1016/j.euf.2026.07.003. Online ahead of print. PMID 42728112
- DERIVEDHori T, Iwamoto H, Inaba T, Nakagawa R, Kamijima T, Makino T, Naito R, Kadomoto S, Yaegashi H, Shigehara K, Nohara T, Izumi K, Mizokami A. Integrating NCCN and LATITUDE in metastatic castration-sensitive prostate cancer: a TITAN analysis. World J Urol. 2026 Aug 19;44(1):585. doi: 10.1007/s00345-026-06695-5.