SWOG-9921 is another study addressing whether adjuvant hormonal therapy alone is sufficient to prevent relapse or whether combined chemotherapy and hormonal therapy is more effective. The trial, which recently stopped enrolling patients, randomized patients with cT1-T2b disease treated locally with radical retropubic prostatectomy (RRP) into one of two treatment arms: hormonal therapy consisting of subcutaneous goserelin once every 13 weeks and oral bicalutamide once daily for two years, or the same hormonal regimen plus IV mitoxantrone once every three weeks for six cycles and oral prednisone twice daily.
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In a separate randomized phase III trial, the VA Cooperative Study #553, adjuvant chemotherapy with docetaxel and prednisone will be compared with active surveillance for recurrence in a cohort of high-risk post-RRP patients. If PSA progression is detected, patients will receive treatment with radiation therapy or ADT.
Conclusion
Many questions regarding the management of locally advanced prostate cancer remain unanswered. Further research is needed to determine the best candidates for treatment, optimal types of combinations, and durations of treatment. Adjuvant therapy has many valid theoretical benefits to patients and early research supports its feasibility in post-prostatectomy patients who are at high risk for relapse.
The clinical paradigms in prostate cancer have shifted considerably to earlier phases of the disease over the past several years. Most patients have no evidence of metastasis today and consequently the role of our systemic modalities of treatment, hormonal therapy and chemotherapy, is much less well defined. Clinical trials represent the appropriate way of defining new standards of care and provide the opportunity to evaluate new approaches that may enhance the quality and quantity of life of our patients.
Clearly the benefits from treatment in the early disease (non-metastatic) paradigm are most likely much more consequential to our patients than the primarily palliative effects in the end-stage metastatic stage of the disease. As a medical community, we need to encourage more patients to participate in clinical trials. Of the 20,000 high-risk patients who undergo prostatectomy annually, a mere 1% are en-rolled, a clear sign that greater awareness and recruitment is needed.
Dr. Eisenberger is the R. Dale Hughes professor of oncology and urology at Johns Hopkins Univer-sity in Baltimore.
