External Validation of a Prognostic Model of Overall Survival in Men With Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer
Open accessAbstract
PURPOSE: We have previously developed and externally validated a prognostic model of overall survival (OS) in men with metastatic, castration-resistant prostate cancer (mCRPC) treated with docetaxel. We sought to externally validate this model in a broader group of men with docetaxel-naïve mCRPC and in specific subgroups (White, Black, Asian patients, different age groups, and specific treatments) and to classify patients into validated two and three prognostic risk groupings on the basis of the model. METHODS: Data from 8,083 docetaxel-naïve mCRPC men randomly assigned on seven phase III trials were used to validate the prognostic model of OS. We assessed the predictive performance of the model by computing the time-dependent area under the receiver operating characteristic curve (tAUC) and validated the two-risk (low and high) and three-risk prognostic groups (low, intermediate, and high). RESULTS: The tAUC was 0.74 (95% CI, 0.73 to 0.75), and when adjusting for the first-line androgen receptor (AR) inhibitor trial status, the tAUC was 0.75 (95% CI, 0.74 to 0.76). Similar results were observed by the different racial, age, and treatment subgroups. In patients enrolled on first-line AR inhibitor trials, the median OS (months) in the low-, intermediate-, and high-prognostic risk groups were 43.3 (95% CI, 40.7 to 45.8), 27.7 (95% CI, 25.8 to 31.3), and 15.4 (95% CI, 14.0 to 17.9), respectively. Compared with the low-risk prognostic group, the hazard ratios for the high- and intermediate-risk groups were 4.3 (95% CI, 3.6 to 5.1; P < .0001) and 1.9 (95% CI, 1.7 to 2.1; P < .0001). CONCLUSION: This prognostic model for OS in docetaxel-naïve men with mCRPC has been validated using data from seven trials and yields similar results overall and across race, age, and different treatment classes. The prognostic risk groups are robust and can be used to identify groups of patients for enrichment designs and for stratification in randomized clinical trials. [Media: see text]
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Multiple clinical factors, including PSA, alkaline phosphatase, hemoglobin, albumin, and lactate dehydrogenase, have demonstrated an association with varying prognoses in mCRPC.
“In addition to visceral metastases, multiple clinical factors have demonstrated an association with varying prognoses, including PSA, alkaline phosphatase, hemoglobin, albumin, and lactate dehydrogenase [48–50].”
From Navigating therapeutic sequencing in the metastatic castration-resistant prostate cancer patient journey (2025) · cites this paper as [50]
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Fadlullah, M. Z. H., Haaland, B., Wang, L., Tan, A. C., & Kohli, M. (2026) · The Journal of Liquid Biopsy · doi:10.1016/j.jlb.2026.100495
- Authors
- Halabi, S., Yang, Q., Roy, A., Luo, B., Araujo, J. C., Logothetis, C., Sternberg, C. N., Armstrong, A. J., Carducci, M. A., Chi, K. N., de Bono, J. S., Petrylak, D. P., Fizazi, K., Higano, C. S., Morris, M. J., Rathkopf, D. E., Saad, F., Ryan, C. J., Small, E. J., & Kelly, W. K.
- Affiliations
- Duke University (US)
- The University of Texas MD Anderson Cancer Center (US)
- NewYork–Presbyterian Hospital (US)
- Johns Hopkins University (US)
- BC Cancer Agency (CA)
- The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, Sutton, United Kingdom
- Yale University (US)
- Université Paris-Sud (FR)
- University of British Columbia (CA)
- Memorial Sloan Kettering Cancer Center (US)
- University of Montreal Hospital Center, Montreal, QC, Canada
- University of Minnesota (US)
- University of California, San Francisco (US)
- Thomas Jefferson University (US)
- ORCID
- Halabi, Susan
- Yang, Qian
- Roy, Akash
- Luo, Bin
- Araujo, John C.
- Logothetis, Christopher
- Sternberg, Cora N.
- Armstrong, Andrew J.
- Carducci, Michael A.
- Chi, Kim N.
- de Bono, Johann S.
- Petrylak, Daniel P.
- Fizazi, Karim
- Higano, Celestia S.
- Morris, Michael J.
- Rathkopf, Dana E.
- Saad, Fred
- Ryan, Charles J.
- Small, Eric J.
- Kelly, William Kevin
- Venue
- Journal of Clinical Oncology
- Published
- 2023-05-20
- Volume
- 41
- Issue
- 15
- Pages
- 2736-2746
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- PMC
- PMC10414709
- OpenAlex
- W4364374948
- Cited by
- 30
- References
- 41
- Citations by year
- 2026: 8 · 2025: 8 · 2024: 11 · 2023: 3
- FWCI
- 5.50
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Licence
- other-oa
- Locations
- Journal of Clinical Oncology (publishedVersion)
- PubMed Central (publishedVersion, other-oa)
- PubMed (publishedVersion)
- Funders
- Prostate Cancer Foundation
- Bristol-Myers Squibb
- AstraZeneca
- Yale University
- Celgene
- Active Biotech
- National Institutes of Health (W81XWH, UL1TR001863)
- National Cancer Institute (R01CA249279, P30CA008748, R01CA256157)
- National Center for Advancing Translational Sciences
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Prostate Cancer Treatment and Research
- Health Sciences › Medicine › Oncology › Bone health and treatments
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Prostate Cancer Diagnosis and Treatment
- Keywords
- metastatic castration-resistant prostate cancer, prognostic model, overall survival, external validation, prognostic subgroups, androgen receptor antagonists, first-line therapy, racial differences, age differences, time-dependent AUC, risk stratification, treatment response prediction
- MeSH terms
- Docetaxel, Antineoplastic Combined Chemotherapy Protocols, Humans, Male, Prognosis, Proportional Hazards Models, Treatment Outcome, Prostatic Neoplasms, Castration-Resistant
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