ArticleEuropean urology open science2026
Oncologic Outcomes in a Contemporary "PROTEUS-like" Cohort of High-risk Prostate Cancer Treated with Radical Prostatectomy Without Neoadjuvant Hormonal Therapy.
Article in European urology open science, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03767244 (A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Apalutamide in Subjects With High-risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy), which is not on this map. Not yet cited in PubMed.
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A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Apalutamide in Subjects With High-risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy
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13 authors.
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Abstract
Background and objective: High-risk prostate cancer (PCa) carries substantial risks of recurrence, metastasis, and mortality. Neoadjuvant therapy before radical prostatectomy (RP) remains investigational. The PROTEUS (NCT03767244) trial evaluates perioperative apalutamide + androgen deprivation therapy (ADT) but lacks a surgery-only control cohort. The objective of this study is to characterize oncologic outcomes in patients with PROTEUS-like high-risk PCa undergoing RP without neoadjuvant therapy. Methods: We performed a retrospective, single-center cohort study of consecutive patients fulfilling PROTEUS high-risk criteria who underwent RP with lymphadenectomy without prior ADT or neoadjuvant treatment. The primary outcome was biochemical recurrence-free survival (BCR-FS). Secondary outcomes included metastasis-free survival (MFS), event-free survival (EFS), and cancer-specific survival (CSS). Key findings and limitations: Among 1392 patients, median follow-up was 60 mo (95% confidence interval [CI], 56-64); 67% received postoperative radiotherapy. BCR-FS at 36, 60, and 120 mo was 60% (95% CI, 57-64), 44% (95% CI, 40-49), and 22% (95% CI, 17-28), respectively. MFS was 79% (95% CI, 76-83), 71% (95% CI, 66-76), and 56% (95% CI, 47-65), respectively. EFS was 56% (95% CI, 52-60), 40% (95% CI, 36-45), and 18% (95% CI, 13-23), respectively. CSS remained high at 95.5% (95% CI, 94-97), 92% (95% CI, 90-94), and 86% (95% CI, 81-91), respectively. Limitations include the retrospective, single-center design, absence of centralized pathology review, and maturing follow-up. Conclusions and clinical implications: These findings demonstrate substantial rates of recurrence and metastatic progression despite contemporary management, underscoring the persistent unmet need in this population and providing a rationale for prospective evaluation of perioperative treatment intensification strategies such as PROTEUS.
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