Oxybutynin significantly decreases frequency and severity of hot flashes in men on ADT

Oxybutynin was superior to placebo for managing hot flashes associated with androgen deprivation therapy (ADT), results from the phase 2 Alliance 222011 trial showed.

Hot flashes are among the most common adverse events affecting quality-of-life in patients receiving ADT for prostate cancer treatment. Oxybutynin effectively reduces the frequency and severity of hot flashes in women [1]. The phase 2 Alliance 222001 trial (NCT04600336) evaluated the benefit of oxybutynin in men receiving ADT. Dr Brad Stish (Mayo Clinic, MN, USA) presented the results [2].

Participants with prostate cancer receiving a stable regimen of ADT who reported at least 28 hot flashes per week were randomised (1:1:2) to receive oral oxybutynin 2.5 mg twice daily, oxybutynin 5 mg twice daily, or a placebo for 6 weeks.

Oxybutynin significantly decreased the hot flash frequency and score (frequency x severity; see Figure). The percentage of participants achieving at least a 50% reduction in the hot flash score was significantly higher in both oxybutynin arms compared with placebo (P=0.0031 and P=0.0009 for low- and high-dose oxybutynin, respectively). Both doses of oxybutynin improved quality-of-life scores, measured on the Hot Flash Related Daily Interference Scale. Oxybutynin was well tolerated without substantial toxicity.

Figure: Mean percentage of baseline hot flash frequency by week [2]



Based on these results, Dr Stish concluded that “oxybutynin is superior to a placebo for the management of hot flashes associated with ADT in men.”

1. Leon-Ferre RA, et al. JNCI Cancer Spectr. 2019;4:pkz088.
2. Stish BJ, et al. Alliance A222001: A randomized, double-blind, placebo controlled phase II study of oxybutynin versus placebo for the treatment of hot flashes in men receiving androgen deprivation therapy. Abstract 12004, ASCO Annual Meeting 2024, 31 May–4 June, Chicago, IL, USA.

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Posted on 18 July 202419 July 2024