Journal article
Deep and Durable Prostate-specific Antigen Response to Darolutamide with Androgen Deprivation Therapy and Docetaxel, and Association with Clinical Outcomes for Patients with High- or Low-volume Metastatic Hormone-sensitive Prostate Cancer: Analyses of the Randomized Phase 3 ARASENS Study
European urology, v 86(4), pp 329-339
01 Oct 2024
PMID: 38644146
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
Darolutamide led to deep and durable prostate-specific antigen (PSA) responses and a higher proportion of patients with undetectable PSA in comparison to placebo when combined with androgen deprivation therapy and docetaxel, regardless of disease volume. Achievement of undetectable PSA was associated with longer survival and longer times to castration-resistant prostate cancer and PSA progression.
Addition of darolutamide to androgen deprivation therapy (ADT) and docetaxel significantly improved overall survival (OS) in ARASENS (NCT02799602). Here we report on prostate-specific antigen (PSA) responses and their association with outcomes.
ARASENS is an international, double-blind, phase 3 study in patients with metastatic hormone-sensitive prostate cancer (mHSPC) randomized to darolutamide 600 mg orally twice daily (n = 651) or placebo (n = 654), both with ADT + docetaxel. The proportion of patients with undetectable PSA (<0.2 ng/ml) and time to PSA progression (≥25% relative and ≥2 ng/ml absolute increase from nadir) were compared between groups in prespecified exploratory analyses. PSA outcomes by disease volume and the association of undetectable PSA with OS and times to castration-resistant prostate cancer (CRPC) and PSA progression were assessed in post hoc analyses.
The proportion of patients with undetectable PSA at any time was more than doubled with darolutamide versus placebo, at 67% versus 29% in the overall population, 62% versus 26% in the high-volume subgroup, and 84% versus 38% in the low-volume subgroup. Darolutamide delayed time to PSA progression versus placebo, with hazard ratios of 0.26 (95% confidence interval [CI] 0.21–0.31) in the overall population, 0.30 (95% CI 0.24–0.37) in the high-volume subgroup, and 0.093 (95% CI 0.047–0.18) in the low-volume subgroup. Undetectable PSA at 24 wk was associated with longer OS, with a hazard ratio of 0.49 (95% CI 0.37–0.65) in the darolutamide group, as well as longer times to CRPC and PSA progression, with similar findings in the disease volume subgroups.
Darolutamide + ADT + docetaxel led to deep and durable PSA responses in patients with high- or low-volume mHSPC. Achievement of undetectable PSA (<0.2 ng/ml) was correlated with better clinical outcomes.
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Details
- Title
- Deep and Durable Prostate-specific Antigen Response to Darolutamide with Androgen Deprivation Therapy and Docetaxel, and Association with Clinical Outcomes for Patients with High- or Low-volume Metastatic Hormone-sensitive Prostate Cancer: Analyses of the Randomized Phase 3 ARASENS Study
- Creators
- Fred Saad - Université de MontréalMaha H.A. Hussain - Feinberg School of Medicine, Northwestern University, Chicago, IL, USABertrand Tombal - Cliniques Universitaires Saint-LucKarim Fizazi - Institut Gustave RoussyCora N. Sternberg - Presbyterian HospitalE. David Crawford - University of California, San DiegoLuke T. Nordquist - XCancer, Omaha, NE, USAMartin Bögemann - University Hospital MünsterRonald Tutrone - United Urology Group, Towson, MD, USANeal D. Shore - Carolina Urologic Research CenterLaurence Belkoff - MidLantic Urology, LLC, Bala Cynwyd, PA, USATodd Fralich - BayerJay Jhaveri - BayerShankar Srinivasan - BayerRui Li - BayerFrank Verholen - BayerIris Kuss - BayerMatthew R. Smith - Massachusetts General Hospital
- Publication Details
- European urology, v 86(4), pp 329-339
- Publisher
- Elsevier
- Number of pages
- 11
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Surgery
- Web of Science ID
- WOS:001321378400001
- Scopus ID
- 2-s2.0-85190819178
- Other Identifier
- 991021916907304721
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- Collaboration types
- Industry collaboration
- Domestic collaboration
- International collaboration
- Web of Science research areas
- Urology & Nephrology