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Alicia Morgans, MD, MPH, discusses data from the ARAMIS trial showing the association between PSA levels and radiological progression in nmCRPC.
Alicia Morgans, MD, MPH, genitourinary medical oncologist, medical director, Survivorship Program, Dana-Farber Cancer Institute; associate professor, medicine, Harvard Medical School, discusses findings from the follow-up analysis of the phase 3 ARAMIS trial (NCT02200614) in nonmetastatic castration-resistant prostate cancer (nmCRPC).
ARAMIS evaluated the association between prostate-specific antigen (PSA) levels and the risk of radiological progression in patients with nmCRPC who received androgen deprivation therapy (ADT) in combination with either darolutamide (Nubeqa) or placebo.
When evaluating the types of progression that patients in this study developed, investigators found that a subgroup of patients exhibited evidence of radiographic progression per CT scans or bone scans before developing PSA progression, Morgans begins. These instances of radiographic progression acted as warning signs for eventual PSA progression, Morgans notes. In total, 4.2% of patients in the darolutamide arm and 5% of those in the ADT plus placebo arm had radiographic progression.
Traditionally, oncologists are often concerned that treatment intensification, particularly in the hormonal activity pathway, might cause patients with nmCRPC to develop increasingly aggressive disease that behaves like neuroendocrine disease and may lead to radiographic progression prior to PSA progression, Morgans explains. However, the ARAMIS trial did not demonstrate high levels of initial radiographic progression with the darolutamide-based regimen, Morgans emphasizes. A numerically lower percentage of patients experienced radiographic progression in the darolutamide arm vs the placebo arm.
Notably, some patients had progression that was detected by CT or bone scans before they developed PSA progression. This indicates the importance of repeating scans at regular intervals to catch more instances of disease progression that occur before the manifestation of clinical symptoms or PSA progression, according to Morgans. Patients who have painful clinical progression will always have a poorer prognosis and more difficult-to-treat disease than those whose disease progression is caught before symptoms develop, Morgans says. Therefore, conducting scans at routine time points, such as every 6 months or every year, is crucial in clinical practice, Morgans concludes.