Trial reportBMC urology2020
Skin rash following Administration of Apalutamide in Japanese patients with Advanced Prostate Cancer: an integrated analysis of the phase 3 SPARTAN and TITAN studies and a phase 1 open-label study.
Trial report in BMC urology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 3 registered trials, which are not on this map. Cited by 33 papers.
What it found
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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.
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men With Non-Metastatic (M0) Castration-Resistant Prostate Cancer
A Phase 1 Study of Androgen Receptor (AR) Antagonist JNJ-56021927 in Subjects With Metastatic Castration-Resistant Prostate Cancer
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)
Who cites it
33 citing papers in PubMed, 64 citations in OpenAlex.
- Impact of a rash management guide in patients receiving apalutamide for high-risk localized prostate cancer in the Apa-RP study.Prostate cancer and prostatic diseases · 2025Trial
- Dermatological Adverse Events in Prostate Cancer Patients Treated with the Androgen Receptor Inhibitor Apalutamide.The Journal of urology · 2022Trial
- Pharmacovigilance of Androgen Receptor Pathway Inhibitors in Prostate Cancer: The Impact of Docetaxel Co-Reporting.Cancers · 2026Article
- Lichenoid dermatosis after apalutamide treatment: Two case reports and literature review.JAAD case reports · 2026Article
- Effect of apalutamide dosage on the incidence of cutaneous adverse events and prostate-specific antigen reduction in patients with prostate cancer.Oncology letters · 2026Article
- Severe exfoliative dermatitis induced by apalutamide in a mHSPC patient: A case report.Medicine · 2026Article
- Apalutamide-induced severe cutaneous adverse reactions in prostate cancer: a comprehensive review of reported cases and clinical strategies.Frontiers in pharmacology · 2026Review
- A Systematic Review of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis: Epidemiology and Treatment Strategies.International journal of general medicine · 2026Review
- Apalutamide-induced rash and relative dose intensity in metastatic castration-sensitive prostate cancer: a multicenter Japanese cohort study.Translational andrology and urology · 2025Article
- Recent advances in drug treatment for prostate cancer.Japanese journal of radiology · 2025Review
- Simultaneous measurement of apalutamide and N-desmethylapalutamide in human plasma using high-performance liquid chromatography with ultraviolet detection.Journal of pharmaceutical health care and sciences · 2025Article
- Comparative real-world study of apalutamide and darolutamide in Japanese patients with non-metastatic castration-resistant prostate cancer.BMC urology · 2025Article
- A randomized study of apalutamide in Chinese patients with non-metastatic castration-resistant prostate cancer.iScience · 2025Article
- Real-world clinical usage and efficacy of apalutamide in men with nonmetastatic castration-resistant prostate cancer: a multi-institutional study in the CsJUC.Japanese journal of clinical oncology · 2025Article
- Incidence and risk factors for dermatologic adverse events following apalutamide use: a real-world data analysis in the Korean population.Prostate international · 2025Article
- Skin rash in metastatic hormone sensitive prostate cancer patients treated with apalutamide: a retrospective multicenter study in Korea.Prostate international · 2025Article
- Apalutamide-associated rash combined with severe neutropenia and eosinophilia: a case report.AME case reports · 2025Article
- A high eosinophil proportion increases the risk of skin-related adverse events induced by apalutamide in patients with prostate cancer.Frontiers in immunology · 2025Article
- Dermatological adverse events in Chinese prostate cancer patients treated with the androgen receptor inhibitor apalutamide.Frontiers in immunology · 2025Article
- Cutaneous Adverse Reactions to Apalutamide: Case Series with Clinical and Pathological Correlations.Acta dermato-venereologica · 2024Article
Corrections and comments
- Erratum issued
Authors and funding
8 authors at 3 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundA higher incidence of apalutamide-related skin rash has been observed in Japanese patients with prostate cancer (PC).
methodsThis integrated analysis of data of Japanese patients from 2 global Phase 3 studies, SPARTAN ( NCT01946204 ; patients with non-metastatic castration-resistant PC [nmCRPC]) and TITAN ( NCT02489318 ; patients with metastatic castration-sensitive PC [mCSPC]), and the Phase 1 study 56021927PCR1008 ( NCT02162836 ; patients with metastatic CRPC [mCRPC]), assessed clinical risk factors of apalutamide-related skin rash as well as the potential correlation with plasma exposure to apalutamide. Kaplan-Meier method was used for time-to-event analyses. Clinical risk factors for skin rash were assessed using odds ratio.
resultsData from 68 patients (SPARTAN: n = 34, TITAN: n = 28, 56021927PCR1008: n = 6) receiving apalutamide 240 mg orally once-daily were analyzed. Rash (13 [19.1%]) and maculo-papular rash (11 [16.2%]) were the most frequently reported skin rash. All Grade and Grade 3 skin rash occurred in 35 (51.5%) and 10 (14.7%) patients, respectively. Most (85.7%) skin rash occurred within 4 months of apalutamide initiation and resolved in a median time of 1 month following the use of antihistamines, topical or systemic corticosteroids, with/without apalutamide dose interruptions/reductions. Median time-to-remission of first incidence of rash and maximum grade incidence of rash were 1.0 month (IQR: 0.36-1.81) and 1.0 month (IQR: 0.30-2.43), respectively. No significant clinical risk factors for the incidence of skin rash were observed. Areas under the curve (0-24 h) (AUC
conclusionsNo clinical risk factors for rash could be detected. There is a potential correlation between incidence of skin rash and plasma exposure to apalutamide. In general, apalutamide-related skin rash is easily managed, with appropriate treatment with or without dose adjustment.
trial registrationRetrospective pooled analysis of NCT01946204 , NCT02489318 , and NCT02162836 .
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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.