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| Title: | 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 |
| Author(s): | Jonas J. Heymann, Mitchell C. Benson, Kathleen
M. O’Toole, Bozena Malyszko, Rachel Brody, Darleen Vecchio,
Peter B. Schiff, Mahesh M. Mansukhani, and Ronald D. Ennis |
| Lay Summary: | In this study, the authors report the results of a novel combination of hormone therapy, and external beam radiotherapy. In this approach, patients are treated with 9 months of hormone therapy. Radiation treatments began after the maximum tumor shrinkage is achieved with the use of hormone therapy. The authors report results similar to approaches which use longer courses of hormone therapy. Importantly, nearly two thirds of patients treated in this way recover their sexual function after hormone therapy is discontinued. This approach may also allow physicians to determine which patients need long-term hormone therapy. |
| Purpose: | To evaluate the toxicity and efficacy of individualized
neoadjuvant androgen deprivation (AD) to maximal response followed
by external beam radiotherapy (RT) with continued AD for a total
of 9 months in a prospective phase II trial. |
| Patients & Methods: | One hundred twenty-three patients received a
total of 9 months of flutamide and luprolide combined with RT. RT
initiation was individualized to begin after maximum response to
AD as assessed by monthly digital rectal examination and prostate-specific
antigen (PSA). The neoadjuvant phase was restricted to no more than
6 months. |
| Results: | Median time to initiation of RT was 4.7 months.
Indications to begin RT (and their rates) were undetectable PSA
(28%), PSA unchanged from one month to the next (46%), PSA rising
from one month to the next (10%), 6 months of AD (14%), and other
(2%). Five-year outcomes were biochemical disease-free survival,
(DFS) 63% 7%; clinical DFS, 75% 5%; cancer-specific survival, 99%
1%; and overall survival, 89% 3%. Patients initiating RT after 6
months of AD had significantly lower biochemical and clinical DFS.
Those patients whose testosterone recovered to normal after completion of AD had a significantly superior survival rate. Of those patients potent before treatment, 65% remained so at last follow-up. |
| Conclusion: | The combination of 9 months of AD and RT, with
initiation of RT individualized on the basis of maximum response
to AD, achieves disease control rates comparable with past studies,
while preserving potency in many patients. Further studies are warranted
to determine the optimal combination of AD and RT in this patient
population. |
Copyright © 2006