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CSR Summary
Not Yet Available
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NCT02489318
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Primary Citation
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Trial Information
Generic NameApalutamideProduct NameERLEADA®Therapeutic AreaAntineoplastic and Immunomodulating AgentsProduct ClassEndocrine TherapyPharmacological SubgroupHormone Antagonists and Related AgentsChemical SubgroupAnti-AndrogensCondition StudiedNeoplasms, Prostatic
Sponsor Protocol Number56021927PCR3002Enrollment1052Data PartnerJohnson & Johnson% FemaleN/AMean/Median Age (Years)68.4% White68.3%
Supporting Documentation
- Collected Datasets Available
- Data Definition Specification Available
- Protocol with Amendments Available
- Statistical Analysis Plan Available
- Clinical Study Report Available
Approved Data Requests Associated with this Trial
- 2026-0916 : Blood pressure during androgen-pathway inhibition in prostate cancer: components, mechanism, and a test of the ESC withholding rule
- 2026-0888 : Individual Patient Data Meta-analysis of Abiraterone Acetate and Apalutamide in Randomized Trials of Prostate Cancer
- 2026-0864 : Early PSA Response, Prognosis, and Treatment Effect Heterogeneity in mHSPC: Individual Participant Data Analysis of TITAN and LATITUDE
- 2026-0820 : Re-evaluating Lung Metastasis in CHAARTED Volume Classification for Overall Survival in mHSPC: An External Validation Study
- 2026-0676 : First Radiographic Progression Phenotypes After Apalutamide in Metastatic Castration-Sensitive Prostate Cancer: A TITAN Secondary Analysis
- 2026-0640 : Understanding Heterogeneity and Improving the Precision of Prostate Cancer Clinical Outcomes in the Modern Era
- 2026-0632 : mHSPC — Phase 3 — Doublet versus Triplet: Early PSA-Response Benchmarks, Kinetics, and Prognostic Associations under Standard of Care
- 2026-0628 : An Open, Tool-Agnostic Benchmark for Evaluating Trial-Design Efficiency Methods Using Completed Oncology Trials
- 2026-0360 : Development of PSA-based tumor growth rate (g-rate) as an early surrogate endpoint in metastatic prostate cancer clinical trials
- 2026-0340 : Radiographic Progression Without PSA Rise in Apalutamide-Treated Advanced Prostate Cancer: An IPD Analysis of TITAN and SPARTAN
- 2026-0328 : A Multi-Trial, Multi-Condition Study of Machine Learning Generalizability in Clinical Outcome Prediction
- 2026-0208 : Impact of Body Mass Index on Survival Outcomes in Patients With castration sensitive prostate cancer and castration resistant prostate cancer
- 2026-0196 : DEFINE: Deep Early Prostate-Specific Antigen (PSA) response Failure: Identifying Nonresponders in Early Metastatic Hormone-Sensitive Prostate Cancer
- 2026-0084 : Optimizing the therapeutic index of AR pathway inhibition in men with advanced prostate cancer (Optima-AR)
- 2025-0928 : Continuation of androgen receptor pathway inhibitors beyond radiographic progression in metastatic hormone-sensitive prostate cancer
- 2025-0920 : Impact of skin adverse events on survival outcomes in metastatic CSPC and non-metastatic CRPC treated with apalutamide
- 2025-0704 : Impact of Age as a Continuous Variable on Outcome in Metastatic Hormone-Sensitive Patients
- 2025-0608 : The impact of metastatic sites on prognosis in Metastatic Prostate Cancer Receiving Androgen Receptor Pathway Inhibitors
- 2025-0600 : Bellmunt Risk Score in mHSPC
- 2025-0508 : The Use of QSAR Machine Learning Methods in Predicting Ultra-Low PSA Responses in Patients treated with Abiraterone and Apalutamide
- 2025-0436 : Prognostic Impact of Low Initial PSA in mHSPC Patients with Extensive Bone Metastases: A Post Hoc Analysis of the TITAN Trial
- 2025-0396 : Heterogeneity in treatment effect of androgen receptor pathway inhibitors in metastatic hormone-sensitive prostate cancer
- 2025-0340 : Bayesian Reanalysis of Prostate Cancer trial
- 2025-0320 : ANDRO-HEME (Androgen Deprivation and Hematologic Effects in Men): An Individual Participant-Level Meta-Analysis of Clinical Trials
- 2025-0268 : Detection of Subgroup Treatment Effects with Missing Patient-Reported Outcomes Data
- 2025-0188 : Deconstructing Patient-Reported Outcomes Using Bayesian Transition Models in Metastatic Prostate Cancer Receiving Androgen Receptor Pathway Inhibitors
- 2025-0172 : Leveraging Data Science Methods to Deliver Individualized Treatment Effects in Metastatic Hormone-Sensitive Prostate Cancer
- 2025-0136 : A novel risk stratification system of metastatic castration-sensitive prostate cancer using CHAARTED and LATITUDE criteria
- 2025-0044 : Machine Learning-Driven Identification of Clinical Subgroups with Heterogeneous Responses to Apalutamide in mCSPC
- 2024-0836 : Patterns of metastasis appearance and prognostic differences based on the type of metastasis in metastatic, castration-sensitive prostate cancer
- 2024-0784 : Investigating the Canonical Polycomb Repressive Complex 1 (cPRC1) as an Intrinsic Mechanism of Resistance to Apalutamide in Advanced Prostate Cancer
- 2024-0652 : IPD meta-analyses of the effects of ADT, docetaxel and androgen receptor pathway inhibitors for hormone-sensitive metastatic prostate cancer
- 2024-0584 : Initial ADT or ADT plus novel androgen receptor signaling inhibitors for patients with metastatic castration-sensitive prostate cancer
- 2024-0392 : Missing data considerations for patient reported outcome measures in randomized controlled trials
- 2024-0384 : Causal Mediation by PSA and pain in metastatic hormone sensitive prostate cancer: a pooled analysis of 5 randomized controlled trials
- 2024-0136 : Volume of bone metastasis and outcomes of apalutamide in patients with metastatic castration-sensitive prostate cancer
- 2023-5534 : Quality tolerance limit and duplicated patient investigation in clinical trials
- 2023-5274 : Statin use and outcomes in patients treated in the SPARTAN, TITAN and ACIS trial
- 2023-5242 : Patterns of disease progression in patients with metastatic, castration-sensitive prostate cancer
- 2023-5187 : The association between antibiotics exposure and outcomes in men with prostate cancer
- 2023-5173 : Improving Outcome in Advanced Prostate Cancer: a Pooled Analysis of Randomized Controlled Trials
