LATITUDE Trial: Addition of Abiraterone to Standard Hormonal Therapy Improves Outcomes in Newly Diagnosed Metastatic Prostate Cancer
Karim Fizazi, Institut Gustave Roussy, Villejuif, France, presented the results of the LATITUDE Trial (Abstract LBA3).
Despite androgen-deprivation therapy, the adrenal glands and prostate cancer cells continue making small amounts of androgens. Abiraterone inhibits production of testosterone throughout the body by blocking an enzyme that converts other hormones to testosterone. The U.S. Food and Drug Administration previously approved abiraterone for patients with metastatic prostate cancer that worsened despite androgen-deprivation therapy. Addition of abiraterone acetate (Zytiga) plus prednisone to standard hormonal therapy for men newly diagnosed with high-risk, metastatic prostate cancer lowers the chance of death by 38%.
About the study
LATITUDE is a multinational, randomized placebo-controlled phase III clinical trial of men with newly diagnosed, high-risk metastatic prostate cancer who had not previously received androgen-deprivation therapy. All patients had at least two of three risk factors: Gleason score of 8 or more, 3 or more bone metastases, or 3 or more visceral metastases.
The patients were randomly assigned to receive androgen-deprivation therapy plus abiraterone and prednisone or androgen-deprivation therapy plus placebo. Corticosteroid prednisone is routinely given with abiraterone to manage certain side effects of abiraterone, such as low potassium or high blood pressure.
In the phase III clinical trial LATITUDE of 1,200 men with newly diagnosed, high-risk metastatic prostate cancer who had not previously received androgen-deprivation therapy, abiraterone more than doubled the median time until the cancer worsened, from 14.8 months to 33 months.