Disease progression patterns and association of prostate-specific antigen level with risk of progression in nonmetastatic castration-resistant prostate cancer.
[BACKGROUND] In ARAMIS, darolutamide statistically significantly prolonged metastasis-free survival by 2 years and reduced the risk of death by 31% in patients with nonmetastatic castration-resistant
- 표본수 (n) 955
APA
Morgans AK, Wallis CJD, et al. (2026). Disease progression patterns and association of prostate-specific antigen level with risk of progression in nonmetastatic castration-resistant prostate cancer.. Prostate cancer and prostatic diseases. https://doi.org/10.1038/s41391-026-01076-w
MLA
Morgans AK, et al.. "Disease progression patterns and association of prostate-specific antigen level with risk of progression in nonmetastatic castration-resistant prostate cancer.." Prostate cancer and prostatic diseases, 2026.
PMID
41680329
Abstract
[BACKGROUND] In ARAMIS, darolutamide statistically significantly prolonged metastasis-free survival by 2 years and reduced the risk of death by 31% in patients with nonmetastatic castration-resistant prostate cancer (nmCRPC). We report post hoc analyses of ARAMIS evaluating patterns of disease progression overall and by prostate-specific antigen (PSA) response.
[METHODS] Patients were randomized 2:1 to darolutamide (n = 955) or placebo (n = 554), with androgen-deprivation therapy (ADT). Progression included metastases on conventional imaging, PSA progression based on Prostate Cancer Working Group 2 criteria or any rise in PSA, and pain progression. Radiological progression was compared between patients who reached undetectable PSA < 0.2 ng/ml at any time and those who did not.
[RESULTS] Metastatic progression occurred in 14% of patients receiving darolutamide versus 29% of patients receiving placebo, with a consistent pattern mostly isolated to bone (46%; 39%) or lymph nodes (32%; 40%). At 12 months, fewer patients receiving darolutamide versus placebo had PSA progression alone (7.8% vs. 35.9%) or both PSA and radiological progression (5.4% vs. 21.4%). Radiological progression without PSA progression occurred in 35% of metastatic events in the darolutamide group and 23% of metastatic events in the placebo group. Darolutamide led to deep PSA response (< 0.2 ng/ml) versus placebo (25.1% vs. 0.5%), and patients receiving darolutamide who reached PSA < 0.2 ng/ml experienced less radiological progression than those who did not (24 months: 8.7% vs. 33%; 36 months: 8.7% vs. 50%).
[CONCLUSIONS] Darolutamide plus ADT reduced the risk of metastatic progression and improved overall survival versus placebo plus ADT without changing patterns of disease progression through Month 24. Metastasis occurred without PSA progression in approximately 30% of metastatic events overall. Undetectable PSA with darolutamide was associated with reduced radiological progression that was maintained over time. These results highlight the importance of both imaging and PSA monitoring to identify disease progression in patients with nmCRPC.
[METHODS] Patients were randomized 2:1 to darolutamide (n = 955) or placebo (n = 554), with androgen-deprivation therapy (ADT). Progression included metastases on conventional imaging, PSA progression based on Prostate Cancer Working Group 2 criteria or any rise in PSA, and pain progression. Radiological progression was compared between patients who reached undetectable PSA < 0.2 ng/ml at any time and those who did not.
[RESULTS] Metastatic progression occurred in 14% of patients receiving darolutamide versus 29% of patients receiving placebo, with a consistent pattern mostly isolated to bone (46%; 39%) or lymph nodes (32%; 40%). At 12 months, fewer patients receiving darolutamide versus placebo had PSA progression alone (7.8% vs. 35.9%) or both PSA and radiological progression (5.4% vs. 21.4%). Radiological progression without PSA progression occurred in 35% of metastatic events in the darolutamide group and 23% of metastatic events in the placebo group. Darolutamide led to deep PSA response (< 0.2 ng/ml) versus placebo (25.1% vs. 0.5%), and patients receiving darolutamide who reached PSA < 0.2 ng/ml experienced less radiological progression than those who did not (24 months: 8.7% vs. 33%; 36 months: 8.7% vs. 50%).
[CONCLUSIONS] Darolutamide plus ADT reduced the risk of metastatic progression and improved overall survival versus placebo plus ADT without changing patterns of disease progression through Month 24. Metastasis occurred without PSA progression in approximately 30% of metastatic events overall. Undetectable PSA with darolutamide was associated with reduced radiological progression that was maintained over time. These results highlight the importance of both imaging and PSA monitoring to identify disease progression in patients with nmCRPC.
같은 제1저자의 인용 많은 논문 (5)
- Managing Drug Interactions with Enzalutamide in Patients with Prostate Cancer: A Podcast.
- Advances in Androgen Deprivation Therapy-Sparing Strategies: Ongoing Studies in Metastatic Castration-Sensitive Prostate Cancer.
- Does Physician Documentation of Patients' Prostate-Specific Antigen Doubling Time Affect Treatment Decisions in High-Risk Biochemically Recurrent Prostate Cancer?
- Pain and health-related quality-of-life outcomes with darolutamide in metastatic hormone-sensitive prostate cancer (ARANOTE): secondary and exploratory analyses of a multicentre, randomised, placebo-controlled, phase 3 trial.
- Associations Between Quality of Life and Disease Progression in Metastatic Hormone-sensitive Prostate Cancer: Insights from ARASENS and ARANOTE Trials.