The role of hormonal treatment for biochemical recurrence in patients following radical prostatectomy

Reviewer: Walter Sall, MD
Last Modified: May 31, 2003

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Presenter: Z. A. Dotan
Presenter's Affiliation: Memorial Sloan Kettering Cancer Center
Type of Session: Scientific


  • Biochemical failure following radical prostatectomy (RP) is common, occurring in 20-40% of patients. 1/4 to 1/3 of these patients receive secondary therapy evenly divided between local radiation and hormone therapy.
  • The benefit of hormone therapy is unclear. Therefore no consensus exists regarding the optimal timing of the initiation of hormone therapy.
  • The intention of this trial is to study the effect of timing of initiation of hormone therapy on overall survival (OS).

Materials and Methods

  • This is a retrospective review of more than 800 patients treated at Memorial Hospital who experience biochemical relapse (BCR) following RP from 1985 to 2002.
  • BCR was defined as a single post-operative PSA of 0.2ng/ml or greater.
  • 186 BCR patients were subsequently given hormone therapy. 129 were given early hormones defined as hormone therapy initiated prior to development of metastases. 57 were given late hormones defined as hormone therapy initiated after the development of metastases.
  • Timing of initiation of hormone therapy was at the discretion of the physician.
  • End points were OS calculated from the time of initiation of hormone therapy and calculated from the time of development of metastases.


  • 8 year actuarial survival was 67.6% for all study patients.
  • Survival from the time of development of metastatic disease was 51.9 months in the early hormone arms and was not calculable in the late hormone arm because too few deaths occurred. However survival was statistically significantly greater in the late hormones arm with p=0.008.
  • There was no significant difference in survival from time of initiation of hormone therapy.

Author's Conclusions

  • Patients treated with early hormone therapy had a shorter survival from the time of development of metastasis than did late hormone patients.
  • Surprisingly, no survival difference from the time of initiation of hormones was seen between the two groups.
  • As a retrospective, non-randomized study with a small patient population, conclusions may be suspect.

Clinical/Scientific Implications

    Not surprisingly, this study shows that survival from the time of development of metastases is greater in hormone naive patients than in those previously treated with hormones. The lack of a survival difference from the time of initiation of hormone therapy between the two groups would seem to indicate that delayed hormone therapy is advantagous. This contradicts previous large, prospective randomized trials which show that early hormone therapy is advantagous. These data may have resulted from the small sample size and retrospective nature of the study. Unfortunately, no data are presented regarding survival from the time of BCR in these patients. This is really the most clinically important figure in these patients. Further prospective randomized trials are necessary to resolve the issue of early vs. late hormones in this patient group.

Oncolink's ASCO Coverage made possible by an unrestricted Educational Grant from Bristol-Myers Squibb Oncology.

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