Aaron Berger, MD, discusses considerations for ARPI treatment breaks

In this interview, Aaron D. Berger, MD, discusses clinical considerations for treatment interruptions among patients receiving androgen receptor pathway inhibitors (ARPIs) for prostate cancer. Berger is the chief medical officer and director of clinical research at Associated Urological Specialists.

Berger identifies patients with high-risk biochemical recurrence who meet the criteria evaluated in the phase 3 EMBARK trial (NCT02319837) as the most common candidates for planned treatment holidays.¹ Specifically, patients who achieve an undetectable prostate-specific antigen (PSA) level may be considered for a temporary interruption, with the goal of allowing testosterone recovery and improving treatment-related quality of life. Berger also discusses other reasons for de-intensifying therapy, including financial toxicity and adverse effects, while emphasizing the importance of maintaining combination therapy when clinically appropriate in advanced prostate cancer.

Berger explains that monitoring during a treatment interruption generally follows the same approach used for patients receiving active therapy. In his practice, this typically involves checking PSA and testosterone levels every 3 months, with imaging performed approximately annually. He does not routinely recommend more frequent laboratory monitoring after stopping treatment, given that testosterone recovery can take time and rapid clinical deterioration is unlikely in appropriately selected patients. However, earlier reassessment or additional imaging may be warranted if PSA increases significantly or clinical concerns arise.

Finally, Berger emphasizes the importance of evaluating testosterone levels alongside PSA kinetics when interpreting results during a treatment holiday. A persistently low PSA may initially be reassuring, but it does not necessarily indicate a sustained treatment response if testosterone remains at castrate levels. Clinicians should counsel patients that testosterone recovery may take time and that PSA trends become more informative as testosterone increases. He notes that the primary goal of a treatment interruption is to improve quality of life and help patients regain some of the physical benefits associated with testosterone recovery, while recognizing that treatment will likely need to be restarted if PSA begins to rise.

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REFERENCE

1. Shore ND, Seiber PR, De Giorgi U, et al. DURATION OF TREATMENT SUSPENSION AMONG ALL RANDOMIZED PATIENTS IN EMBARK. J Urol. 2026;215(5S):e1337. doi:10.1097/01.JU.0001191680.76138.83.05