In a groundbreaking national clinical trial spearheaded by the Alliance for Clinical Trials in Oncology, researchers have made a significant discovery: oxybutynin, a medication typically prescribed for overactive bladder issues, has shown promise in alleviating hot flashes in men undergoing hormone therapy for prostate cancer. The primary findings of this study, known as Alliance A222001, are published in the prestigious Journal of Clinical Oncology (https://ascopubs.org/doi/10.1200/JCO-25-01486).
Dr. Bradley J. Stish, the lead investigator and a radiation oncologist at the Mayo Clinic, remarked, "Oxybutynin has clearly demonstrated substantial improvements not only in the frequency of hot flashes but also in the overall quality of life for men receiving hormone therapy for prostate cancer." He emphasized that these findings strongly endorse the drug's potential as an effective strategy to manage this challenging and often neglected side effect associated with prostate cancer treatment.
Androgen-deprivation therapy (ADT) is a widely recognized and effective approach to combating prostate cancer. It works by significantly lowering male hormones, particularly testosterone, which cancer cells rely on for growth. However, a staggering 80% of men undergoing ADT report experiencing hot flashes, which can lead to fatigue, sleep disturbances, and a decline in overall quality of life. These debilitating side effects often result in patients choosing to discontinue their hormone therapy altogether.
This Phase II study was rigorously designed as a randomized, double-blind, placebo-controlled trial aimed at determining whether two different doses of oxybutynin (2.5 mg taken twice daily and 5 mg taken twice daily) could effectively mitigate hot flash symptoms over a six-week period. A total of 88 men from 15 different academic and community cancer centers participated in the study, with 81 individuals qualifying for the final analysis. The average age of participants was 68.5 years.
The results were striking: both doses of oxybutynin led to significant improvements in hot flash symptoms compared to those who received a placebo during the six-week treatment phase. Participants on placebo experienced an average decline of 2.15 hot flashes per day and saw a reduction of 4.85 points in their daily severity scores. In contrast, men taking 2.5 mg of oxybutynin twice daily reported a remarkable decrease of 4.77 hot flashes per day along with a 9.94-point drop in severity scores. Those on the higher dosage of 5 mg twice daily noted the most pronounced benefits, with an impressive reduction of 6.89 hot flashes daily and a 13.95-point improvement in severity.
Notably, the improvements began to manifest quickly, often within the first week of treatment, and persisted throughout the duration of the study. A higher percentage of patients achieved at least a 50% reduction in their hot flash scores with oxybutynin: 57% in the 2.5 mg group and 79% in the 5 mg group, compared to just 32% of those taking the placebo. Overall, the treatment was well-tolerated, with dry mouth being the most frequently reported side effect.
Dr. Stish added, "These findings are incredibly promising. Men suffering from hot flashes due to hormone therapy now have a new therapeutic option that can help alleviate their symptom burden. Future studies will aim to deepen our understanding of treatment options for managing hot flashes in this patient demographic."
Alongside the Mayo Clinic in Rochester, MN, the research team included experts from various institutions such as the Alliance Protocol Operations in Chicago, IL; the Alliance Statistics and Data Management Center at the Mayo Clinic in Scottsdale, AZ; Aspirus Regional Cancer Center in Wausau, WI; Ellis Fischel Cancer Center in Columbia, MO; Georgetown-Lombardi Comprehensive Cancer Center in Washington, DC; Gibbs Cancer Center in Spartanburg, SC; Mayo Clinic Division of Nursing in Jacksonville, FL; Sandra and Edward Meyer Cancer Center at Weill Cornell Medicine in New York, NY; SCOR-Messino Cancer Centers in Ashville, NC; Sidney Kimmel Cancer Center in Baltimore, MD; The Ohio State University in Columbus, OH; and Yale University School of Medicine in New Haven, CT.
This study received funding from the National Cancer Institute, part of the National Institutes of Health, under several award numbers including UG1CA189823 (Alliance for Clinical Trials in Oncology NCORP Grant), UG1CA239762, UG1CA189858, UG1CA239758, and UG1CA239769.
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