(HealthDay News) – For men with localized high-risk prostate cancer, neoadjuvant androgen deprivation therapy with abiraterone acetate (AA) plus leuprolide acetate (LHRHa) is well tolerated and has good pathological complete/near complete response (pCR/near pCR) rates, according to a study released May 16 in advance of presentation at the annual meeting of the American Society of Clinical Oncology, held from June 1–5 in Chicago.
Mary-Ellen Taplin, MD, from Harvard Medical School and the Dana-Farber Cancer Institute in Boston, and colleagues conducted a randomized Phase 2 trial for neoadjuvant AA/LHRHa in 58 men (median age, 58 years) with localized high-risk prostate cancer. Participants were randomly allocated to receive LHRHa (28 men) or AA/LHRHa/prednisone (30 men) for 12 weeks. After 12 weeks, all men received AA/LHRHa/prednisone for a further 12 weeks, followed by radical prostatectomy.
The researchers found that the pCR/near pCR was 25% overall, and was 34% for those treated with AA for 24 weeks and 15 percent for those treated with AA for 12 weeks. Grade 3 elevated aspartate aminotransferase/alanine aminotransferase and hypokalemia were seen in 9% and 5% of patients, respectively, and no Grade 4 mineralocorticoid-related adverse events were observed.
“For this proportion of patients with high-risk disease to have very little to no detectable cancer in the prostate after six months of therapy is dramatic,” Taplin said in a statement. “Our findings suggest that this combination therapy approach could improve outcomes for a substantial number of men, but larger, long-term trials are needed to confirm this approach.”
Several authors disclosed financial ties to pharmaceutical companies, including Johnson & Johnson, which manufactures abiraterone acetate.