Intermittent Androgen Suppression for Rising PSA Level after Radiotherapy Academic Article uri icon

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abstract

  • BACKGROUND: Intermittent androgen deprivation for prostate-specific antigen (PSA) elevation after radiotherapy may improve quality of life and delay hormone resistance. We assessed overall survival with intermittent versus continuous androgen deprivation in a noninferiority randomized trial. METHODS: We enrolled patients with a PSA level greater than 3 ng per milliliter more than 1 year after primary or salvage radiotherapy for localized prostate cancer. Intermittent treatment was provided in 8-month cycles, with nontreatment periods determined according to the PSA level. The primary end point was overall survival. Secondary end points included quality of life, time to castration-resistant disease, and duration of nontreatment intervals. RESULTS: Of 1386 enrolled patients, 690 were randomly assigned to intermittent therapy and 696 to continuous therapy. Median follow-up was 6.9 years. There were no significant between-group differences in adverse events. In the intermittent-therapy group, full testosterone recovery occurred in 35% of patients, and testosterone recovery to the trial-entry threshold occurred in 79%. Intermittent therapy provided potential benefits with respect to physical function, fatigue, urinary problems, hot flashes, libido, and erectile function. There were 268 deaths in the intermittent-therapy group and 256 in the continuous-therapy group. Median overall survival was 8.8 years in the intermittent-therapy group versus 9.1 years in the continuous-therapy group (hazard ratio for death, 1.02; 95% confidence interval, 0.86 to 1.21). The estimated 7-year cumulative rates of disease-related death were 18% and 15% in the two groups, respectively (P=0.24). CONCLUSIONS: Intermittent androgen deprivation was noninferior to continuous therapy with respect to overall survival. Some quality-of-life factors improved with intermittent therapy. (Funded by the Canadian Cancer Society Research Institute and others; ClinicalTrials.gov number, NCT00003653.).

authors

  • Crook, Juanita M
  • O'Callaghan, Christopher J
  • Duncan, Graeme
  • Dearnaley, David P
  • Higano, Celestia S
  • Horwitz, Eric M
  • Frymire, Eliot
  • Malone, Shawn
  • Chin, Joseph
  • Nabid, Abdenour
  • Warde, Padraig
  • Corbett, Tom
  • Angyalfi, Steve
  • Goldenberg, S Larry
  • Gospodarowicz, Mary K
  • Saad, Fred
  • Logue, John P
  • Hall, Emma
  • Schellhammer, Paul F
  • Ding, Keyue
  • Klotz, Laurence

publication date

  • September 6, 2012