Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2023
Darolutamide Maintenance in Patients With Metastatic Castration-Resistant Prostate Cancer With Nonprogressive Disease After Taxane Treatment (SAKK 08/16).
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
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The trial behind it
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Who cites it
5 citing papers in PubMed, 10 citations in OpenAlex.
- Progression-Free Survival Effect Sizes in Randomized Controlled Trials of Targeted Cancer Therapies with Positive Outcomes.Acta haematologica · 2026Article
- Induction of apoptosis and growth inhibition by silodosin and abiraterone acetate in PC-3 human prostate cancer cells.Investigative and clinical urology · 2025Article
- A Bayesian Network Meta-analysis of Systemic Treatments for Metastatic Castration-Resistant Prostate Cancer in First- and Subsequent Lines.Targeted oncology · 2025Article
- Effects of decursinol angelate on viability and apoptosis in PC-3 prostate cancer cells: In vitro study.Narra J · 2024Article
- Article
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Authors and funding
20 authors at 14 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo assess the efficacy and safety of darolutamide maintenance after successful taxane chemotherapy in patients with metastatic castration-resistant prostate cancer (mCRPC). PATIENTS AND
methodsSwiss Group for Clinical Cancer Research (SAKK) 08/16 is a randomized phase II study. Patients with mCRPC who received prior androgen-receptor pathway inhibitors (ARPIs) and subsequently had nonprogressive disease on a taxane were randomly assigned to darolutamide 600 mg twice a day or placebo twice a day. The primary end point was radiographic progression-free survival (rPFS) at 12 weeks. Secondary end points were rPFS, event-free survival, overall survival (OS), prostate-specific antigen (PSA) 50% response rate, and adverse events.
resultsOverall, 92 patients were recruited by 26 centers. Prior taxane was docetaxel in 93% and cabazitaxel in 7%. Prior ARPI was abiraterone in 60%, enzalutamide in 31%, and both in 9%. rPFS at 12 weeks was significantly improved with darolutamide (64.7%
conclusionSAKK 08/16 met its primary end point, showing that switch maintenance with darolutamide after prior taxane chemotherapy and at least one ARPI resulted in a statistically significant but clinically modest rPFS prolongation with good tolerability. The median OS with darolutamide maintenance appears promising. Should these findings be confirmed in a larger trial, maintenance treatment could be a novel strategy in managing patients with mCRPC, especially those who responded well to prior ARPI.
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