Trial reportInternational journal of urology : official journal of the Japanese Urological Association2022
Safety and efficacy of apalutamide in Japanese patients with metastatic castration-sensitive prostate cancer receiving androgen deprivation therapy: Final report for the Japanese subpopulation analysis of the randomized, placebo-controlled, phase III TITAN study.
Trial report in International journal of urology : official journal of the Japanese Urological Association, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
12 citing papers in PubMed, 23 citations in OpenAlex.
- Genetic Predictors of Progression and Skin Rash in Japanese mCSPC Patients Treated With Apalutamide: CUARTET Study.Cancer science · 2026Trial
- Darolutamide in Japanese patients with metastatic hormone-sensitive prostate cancer: Phase 3 ARASENS subgroup analysis.Cancer medicine · 2024Trial
- Skin Rash Management Based on Early Elevation in the Eosinophil Proportion Within 3 Months of Initiating Apalutamide for Prostate Cancer.Cancer reports (Hoboken, N.J.) · 2026Article
- Androgen Receptor Signaling Inhibitors for Metastatic Hormone Sensitive Prostate Cancer in Asians: Indirect Comparison.Cancer reports (Hoboken, N.J.) · 2026Article
- Apalutamide-induced severe cutaneous adverse reactions in prostate cancer: a comprehensive review of reported cases and clinical strategies.Frontiers in pharmacology · 2026Review
- Efficacy and Safety of Combination Androgen-Receptor Signaling Inhibitors, Denosumab, and Local Radiotherapy for Poly-Metastatic Prostate Cancer.Cancer reports (Hoboken, N.J.) · 2025Article
- A Case of Drug-Induced Hypersensitivity Syndrome Caused by Apalutamide.IJU case reports · 2025Article
- Efficacy of androgen receptor signaling inhibitors in combination with androgen deprivation therapy for castration-sensitive metastatic prostate cancer: a retrospective analysis in a Japanese cohort.International journal of clinical oncology · 2025Article
- Cutaneous Adverse Reactions to Apalutamide: Case Series with Clinical and Pathological Correlations.Acta dermato-venereologica · 2024Article
- Editorial Comment to Safety and efficacy of apalutamide in Japanese patients with metastatic castration-sensitive prostate cancer receiving androgen deprivation therapy: Final report for the Japanese subpopulation analysis of the randomized, placebo-controlled, phase III TITAN study.International journal of urology : official journal of the Japanese Urological Association · 2022Article
- Drug Resistance and Cardiovascular Safety of Second-Generation Anti-Androgens in Patients with Advanced Prostate Cancer : Second-Generation Antiandrogen Use in Advanced Prostate Cancer.Galen medical journal · 2022Review
- Oligometastatic carcinoma prostate - An overview of the last decade.Indian journal of urology : IJU : journal of the Urological Society of IndiaReview
Corrections and comments
- Commented on by
Authors and funding
12 authors at 5 institutions in 4 countries.
Funding
Abstract
objectivesThe TITAN study is a randomized, double-blind, placebo-controlled, multinational trial that evaluated apalutamide with androgen deprivation therapy in patients with metastatic castration-sensitive prostate cancer. At the first interim analysis in the Japanese subpopulation (median follow-up 25.7 months), there was an improvement in overall survival and radiological progression-free survival with apalutamide versus placebo. Here, we report the final analysis results for the Japanese subpopulation.
methodsPatients were randomized 1:1 to receive apalutamide 240 mg or placebo. After the first interim analysis, protocol treatment was unblinded, and crossover was allowed. Efficacy and safety were evaluated in the preplanned, event-driven final analysis.
resultsFifty-one patients were Japanese (apalutamide n = 28; placebo n = 23). After a median follow-up of 46.0 months, the median overall survival was not reached neither in the apalutamide nor the placebo group; the hazard ratio was 0.45, favoring apalutamide, which was consistent with the overall population. Hazard ratios for time to cytotoxic chemotherapy (0.39), time to pain progression (0.87), and time to chronic opioid use (0.82) also favored apalutamide and were comparable with those of the overall population. Time to prostate-specific antigen progression and progression-free survival 2, respectively, was favored in the apalutamide group (0.21 and 0.44). Apalutamide was associated with higher incidences of rash and fracture in the Japanese subpopulation compared with the overall population.
conclusionsThe efficacy of apalutamide with androgen deprivation therapy in Japanese patients was consistent with efficacy demonstrated in the overall population. No new safety concerns emerged with long-term follow-up.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.