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Phase II Study of Neoadjuvant Androgen Deprivation Followed by External-Beam Radiotherapy With 9 Months of Androgen Deprivation for Intermediate- to High-Risk Localized Prostate Cancer Show Comments PDF Print E-mail
  
Monday, 16 April 2007

BERKELEY, CA (UroToday.com) - The timing of radiotherapy (XRT) and androgen deprivation therapy (ADT) as well as the extent of ADT varies. This impacts oncologic and morbidity related outcomes. Dr. Heymann and associates from Columbia University report in the January 1, 2007 issue of the Journal of Clinical Oncology that initiating XRT based upon the response to ADT is a rational strategy that may lessen treatment related morbidity.

In a Phase II trial, 123 patients received XRT with 9 months of ADT. ADT was neoadjuvant to achieve maximal response by PSA and digital rectal examination. An undetectable or rising PSA and stable DRE defined maximal response. Patients began XRT no later than 6 months following initiation of ADT. XRT to 72.5 Gy was then given for up to a 9 month total.

The primary endpoint was biochemical disease-free survival (BDFS). Clinical disease-free survival (CDFS) was a secondary endpoint. Overall survival, cause-specific survival and toxicity were also assessed.

Patients with a baseline PSA >30ng/ml were significantly more likely to fail BDFS at 5 years than patients with initial PSA levels less than 30ng/ml. Patients who began XRT after 6 months were more likely to have a failure of BDFS at five years than those who began XRT with an undetectable, nadir or rising PSA. Interestingly, clinical stage, Gleason score, risk group, race, initial PSA, age and complete response to DRE failed to predict for PSA failure. In multivariate analysis, only the indication to begin XRT independently predicted BDFS. Multivariate analysis demonstrated that both Gleason score and indication to begin XRT predicted CDFS.

Testosterone returned to normal in 69% of patients with a median time to recovery of 9 months. Testosterone returned to it baseline level after ADT in 37% with a median recovery time of 11 months. Patients who recovered testosterone to normal levels after ADT were not more likely to fail BDFS or CDFS at 5 years. Due to the small numbers of deaths, cause of death analysis was limited but there was no difference in cause of death between those who did and did not recover testosterone to normal levels. The majority of patients lost potency during treatment, but up to 65% recovered some potency after treatment.

Jonas J. Heymann, Mitchell C. Benson, Kathleen M. O'Toole, Bozena Malyszko, Rachel Brody, Darleen Vecchio, Peter B. Schiff, Mahesh M. Mansukhani, Ronald D. Ennis

J Clin Oncol 2007; 25(1) :77-84.

UroToday.com Prostate Cancer Section

Written by Christopher P. Evans, MD, a Contributing Editor with UroToday.

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