Trial reportJapanese journal of clinical oncology2018
Efficacy and safety of abiraterone acetate plus prednisone in Japanese patients with newly diagnosed, metastatic hormone-naïve prostate cancer: a subgroup analysis of LATITUDE, a randomized, double-blind, placebo-controlled, Phase 3 study.
Trial report in Japanese journal of clinical oncology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 2 of them syntheses that pooled it.
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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
15 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Pan-Asian adapted ESMO Clinical Practice Guidelines for the diagnosis, treatment and follow-up of patients with prostate cancer.ESMO open · 2022Guideline
- Abiraterone acetate in combination with androgen deprivation therapy compared to androgen deprivation therapy only for metastatic hormone-sensitive prostate cancer.The Cochrane database of systematic reviews · 2020Pooled it
- Efficacy and safety of abiraterone acetate plus prednisone in Japanese patients with newly diagnosed, metastatic hormone-naive prostate cancer: final subgroup analysis of LATITUDE, a randomized, double-blind, placebo-controlled, phase 3 study.Japanese journal of clinical oncology · 2020Trial
- A randomized, double-blind, comparison of radium-223 and placebo, in combination with abiraterone acetate and prednisolone, in castration-resistant metastatic prostate cancer: subgroup analysis of Japanese patients in the ERA 223 study.International journal of clinical oncology · 2020Trial
- Cancer-Control Outcomes of Japanese Vs. German Metastatic Hormone-Sensitive Prostate Cancer Patients: A Real-World Cross-Country Comparison of Patients Undergoing Combination Therapies.International journal of urology : official journal of the Japanese Urological Association · 2026Article
- Novel hormonal therapies in the management of advanced prostate cancer: extrapolating Asian findings to Southeast Asia.BMC urology · 2023Review
- Comparison of clinical outcomes between androgen deprivation therapy with up-front abiraterone and bicalutamide for Japanese patients with LATITUDE high-risk prostate cancer in a real-world retrospective analysis.International journal of clinical oncology · 2022Article
- Time trends of drug-specific actionable adverse events among patients on androgen receptor antagonists: Implications for remote monitoring.Canadian Urological Association journal = Journal de l'Association des urologues du Canada · 2022Article
- Efficacy and safety of therapies for advanced prostate cancer in Asia: Evidence from a systematic literature review.Therapeutic advances in medical oncology · 2022Review
- Revision of CHAARTED and LATITUDE criteria among Japanese de novo metastatic prostate cancer patients.Prostate international · 2021Article
- Prognostic impact of bone metastatic volume beyond vertebrae and pelvis in patients with metastatic hormone-sensitive prostate cancer.International journal of clinical oncology · 2021Article
- Comparison of Abiraterone and Combined Androgen Blockade Therapy for High-Risk Metastatic Hormone-Sensitive Prostate Cancer: A Propensity Score-Matched Analysis.Frontiers in oncology · 2021Article
- Efficacy of abiraterone combined with flutamide on prostate cancer patients and its effect on serum miR-493-5p and miR-195-5p.Oncology letters · 2020Article
- Prognostic Value of the LATITUDE and CHAARTED Risk Criteria for Predicting the Survival of Men with Bone Metastatic Hormone-Naïve Prostate Cancer Treated with Combined Androgen Blockade Therapy: Real-World Data from a Japanese Multi-Institutional Study.BioMed research international · 2020Article
- Three-month Prostate-specific Antigen Level After Androgen Deprivation Therapy Predicts Survival in Patients With Metastatic Castration-sensitive Prostate Cancer.In vivo (Athens, Greece)Article
Corrections and comments
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Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo evaluate the efficacy and safety of abiraterone acetate plus prednisone (AAP) plus androgen-deprivation therapy (ADT) in Japanese subgroup with newly diagnosed, metastatic hormone-naïve prostate cancer (mHNPC) from Phase 3, randomized, global LATITUDE study.
methodsMen with mHNPC having ≥2 of 3 high-risk factors (Gleason score ≥8, ≥3 bone lesions or measurable visceral metastases) randomly received abiraterone acetate 1000-mg+ prednisone 5-mg+ADT (AAP group) or ADT+Placebos (Placebo group). Coprimary endpoints were overall survival (OS) and radiographic progression-free survival (rPFS).
resultsOf total 1199 patients in the LATITUDE study, 70 (5.8%) were Japanese (n = 35 each in the AAP and placebo group). After a median follow-up of 35.02 months (range: 2.5-42.3), median OS was not reached in both AAP group and placebo group (HR: 0.635; 95% CI, 0.152-2.659) and the median length of rPFS was not reached in the AAP group and was 22 months in the placebo group (HR:0.219; 95% CI, 0.086-0.560). The most frequently reported adverse events (>20% in either group) in the Japanese subgroup were hypertension, nasopharyngitis, weight increased, hypokalemia, hot flush, back pain, hyperglycemia, ALT and AST elevation. The incidence of Grade 3 or 4 adverse events was 65.7% (23/35) in the AAP group and 20% (7/35) in the placebo group. The efficacy and safety findings of Japanese subgroup were consistent with that of the overall study population.
conclusionTreatment with AAP plus ADT has shown a positive risk-benefit balance and may serve as a new treatment option to improve the prognosis of Japanese mHNPC patients with high-risk features.
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