Men with high-risk prostate cancer who underwent treatment with radiotherapy plus 18 months of androgen deprivation therapy demonstrated improved testosterone recovery compared with those who underwent radiotherapy plus 36 months of androgen deprivation, according to results of a randomized phase 3 study presented at the ASTRO Annual Meeting.
“Those who recover normal testosterone value have better quality of life,” Abdenour Nabid, MD, radiation oncologist at Centre Hospitalier Universitaire de Sherbrooke and associate professor at the University of Sherbrooke in Quebec, Canada, said during a press conference. “A higher proportion of patients [assigned 18 months of androgen deprivation therapy] recovered normal testosterone value, and they did so in a much shorter time. This was done without any apparent detriment to long-term outcomes.”
Initial results from the multicenter trial, presented at the Genitourinary Cancers Symposium last year, showed comparable OS between those assigned 18 months of androgen deprivation therapy [ADT] and those assigned a 36-month ADT regimen.
In the current analysis, Nabid and colleagues evaluated quality of life after testosterone recovery.
The trial included 561 patients with high-risk prostate cancer. Researchers randomly assigned 289 patients to 18 months of ADT plus radiotherapy. The other 272 underwent 36 months of ADT plus radiotherapy. Radiotherapy for all patients began 4 months after initiation of ADT.
After a median follow-up of 84 months, 161 (55.7%) of patients in the 18-month ADT group had recovered normal testosterone levels, compared with 122 (44.9%) of those assigned 36 months of ADT. Patients in the 18-month ADT group experienced shorter median time to testosterone recovery (47.2 months; range, 40.1-54.3) than those in the 36-month ADT group (73.2 months; range, 58.3-88.2).
Nabid and colleagues measured quality of life by the validated EORTC30 and PR25 questionnaires. The two questionnaires included a combined 55 items, which were grouped into 21 scales.
Patients completed questionnaires prior to treatment, every 6 months during ADT, 4 months after completion of ADT, and again once per year for 5 years post-treatment. More than 9,300 questionnaires were included in the final analysis.
Results showed men who recovered normal testosterone reported better quality of life than those who did not. The differences on 26 of the 55 questionnaire items, as well as 12 of the 21 scales, were statistically significant, researchers wrote.
“In high-risk prostate cancer, the current guideline for ADT duration is between 2 and 3 years,” Nabid said in a press release. “Because of improvement in testosterone recovery and quality of life, a good first step could be to choose ADT for 2 years.”
For more information:
Nabid A. Abstract #24. Presented at: ASTRO Annual Meeting; Sept. 14-17, 2014; San Francisco.
Disclosure: The study was funded by AstraZeneca. The researchers report a research grant from AstraZeneca, as well as honoraria and travel expenses from Sanofi.