Sizzling flashes are some of the frequent and disruptive unwanted effects skilled by males receiving androgen-deprivation remedy (ADT) for prostate most cancers. Now, outcomes from a nationwide randomized scientific trial recommend that oxybutynin, a medicine historically used to deal with overactive bladder, could considerably scale back each the frequency and severity of those signs.
Findings from the section 2 Alliance A222001 trial, not too long ago printed within the Journal of Scientific Oncology, confirmed that males handled with oxybutynin skilled higher and sooner enhancements in sizzling flashes in contrast with those that obtained a placebo. Importantly, the therapy was nicely tolerated, providing a possible new supportive care possibility for sufferers struggling to remain on ADT as a result of unwanted effects.
“Oxybutynin demonstrated clear and clinically significant enhancements in each sizzling flash frequency and high quality of life for males present process hormone remedy for prostate most cancers,” Dr. Bradley J. Stish, lead research investigator and a radiation oncologist on the Mayo Clinic, mentioned in a information launch from the Alliance for Scientific Trials in Oncology. “These outcomes present robust help for its use as an efficient administration possibility for this difficult and sometimes ignored facet impact of prostate most cancers therapy.”
Research Exhibits Oxybutynin Improves Sizzling Flash Frequency and Severity
The randomized, double-blind, placebo-controlled research evaluated two totally different doses of oxybutynin (2.5 milligrams [mg] twice each day and 5 mg twice each day) over a six-week therapy interval. Investigators in contrast outcomes with these of a placebo in males receiving a secure routine of ADT for prostate most cancers.
Outcomes demonstrated a transparent dose-dependent profit. Males who obtained placebo reported a mean discount of two.15 sizzling flashes per day. In distinction, sufferers taking oxybutynin at 2.5 mg twice each day skilled a mean discount of 4.77 sizzling flashes per day, and people receiving 5 mg twice each day reported 6.89 fewer sizzling flashes per day.
Severity scores adopted the same sample. Every day sizzling flash severity scores decreased by 4.85 factors within the placebo group, in contrast with reductions of 9.94 factors and 13.95 factors within the lower- and higher-dose oxybutynin teams, respectively. Enhancements have been typically seen inside the first week of therapy and have been sustained all through the six-week research interval.
A clinically significant discount, outlined as at the least a 50% lower in sizzling flash scores, was achieved by 32% of males receiving placebo. This in contrast with 57% of sufferers within the 2.5-milligram group and 79% of these receiving the upper dose.
Why Sizzling Flashes Happen Throughout Prostate Most cancers Hormone Remedy
ADT stays a cornerstone of therapy for a lot of males with prostate most cancers as a result of it lowers testosterone ranges that gas most cancers development. Nevertheless, this discount in male hormones can disrupt the physique’s temperature regulation, resulting in frequent and intense sizzling flashes.
As much as 80% of males receiving ADT expertise sizzling flashes, which might intrude with sleep, each day actions and total high quality of life. For some sufferers, these signs turn into extreme sufficient to immediate dose interruptions or early discontinuation of remedy, doubtlessly affecting most cancers outcomes. Regardless of the prevalence of this facet impact, few efficient, well-studied therapies have been out there.
Trial Design and Strategies Utilized in Alliance A222001
Alliance A222001 enrolled 88 males from 15 educational and neighborhood most cancers facilities throughout the USA. To be eligible, contributors needed to be receiving ADT and report at the least 28 sizzling flashes per week. A complete of 81 sufferers have been included within the ultimate evaluation.
Contributors have been randomly assigned to obtain oxybutynin 2.5 mg twice each day, oxybutynin 5 mg twice each day, or an identical placebo for six weeks. The first finish level was the change in patient-reported sizzling flash scores from baseline to week six. Secondary outcomes included opposed occasions, adjustments within the Sizzling Flash–Associated Every day Interference Scale and different patient-reported signs.
Affected person Inhabitants and Security Findings
The common age of contributors was 68.5 years, reflecting a typical inhabitants of males handled with ADT. Remedy was typically nicely tolerated, and no treatment-related grade 3 (extreme) or greater unwanted effects have been reported. Dry mouth was the commonest facet impact related to oxybutynin, in line with its identified security profile.
Along with decreasing sizzling flashes, oxybutynin additionally improved quality-of-life measures. Scores on the Sizzling Flash–Associated Every day Interference Scale improved by 14.2 factors within the lower-dose group and 20.7 factors within the higher-dose group, in contrast with a 3.1-point enchancment within the placebo arm.
What These Findings Imply for Sufferers
These outcomes recommend that oxybutynin could supply a sensible and efficient possibility for managing ADT-associated sizzling flashes in males with prostate most cancers. By decreasing symptom burden and bettering each day functioning, this strategy might assist sufferers stay on hormone remedy longer and with higher consolation.
“These outcomes are extremely encouraging,” Stish concluded within the information launch. “Males with sizzling flashes from hormone remedy now have one other therapeutic possibility out there to assist scale back their symptom burden. Future analysis will look to additional our understanding of sizzling flash remedy choices on this affected person inhabitants.”
References
- “Randomized Trial Finds Drug Remedy Reduces Sizzling Flashes Throughout Prostate Most cancers Remedy,” by the Alliance for Scientific Trials in Oncology. Information launch; Feb. 6, 2026.
- “Alliance A222001: Oxybutynin Versus Placebo for the Remedy of Sizzling Flashes in Sufferers Receiving Androgen-Deprivation Remedy for Prostate Most cancers,” by Dr. Bradley J. Stish, et al. The Journal of Scientific Oncology.
Editor’s notice: This text is for informational functions solely and isn’t an alternative to skilled medical recommendation, as your personal expertise will likely be distinctive. Use this text to information discussions along with your oncologist. Content material was generated with AI and reviewed by a human editor.
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