Adult urologyPhase II trial of neoadjuvant docetaxel before radical prostatectomy for locally advanced prostate cancer☆
Section snippets
Material and methods
Twenty-nine patients were enrolled in the study between May 2001 and April 2003. The eligibility criteria included histologically documented locally advanced prostate cancer defined by a serum PSA level of greater than 15 ng/mL (any grade or stage), clinical Stage T2b, T2c, or T3 (any PSA level or grade), or biopsy Gleason sum of 8 or greater (any stage or PSA level). Clinical stage was assigned on the basis of the digital rectal examination findings, according to the 1992 American Joint
Results
The pretreatment characteristics of the study population are outlined in Table I. The pretreatment serum PSA level ranged from 2.5 to 43.3 ng/mL (mean 12.0 ± 1.86, 95% confidence interval 8.20 to 15.8), Gleason sum from 6 to 9 (median 8), and clinical stage from T2b to T3c. The predicted likelihood of organ-confined disease for the 29 enrolled patients ranged from 3% to 34% (median 13%), as determined by the most recent Kattan nomogram.20
Treatment was generally well tolerated, with 22 patients
Comment
The need for innovative, multimodal approaches to locally advanced prostate cancer is illustrated by the results among large contemporary RP series.1, 2, 3 Although patients with favorable preoperative parameters, organ-confined disease, and negative surgical margins can expect an 8-year biochemical disease-free survival rate of 96%,3 patients with locally advanced disease fare much worse. For example, patients with a Gleason sum of 8 or greater have an actuarial 7 to 10-year biochemical
Conclusions
The results of this trial confirmed the feasibility of RP with acceptable surgical morbidity after neoadjuvant therapy with docetaxel in patients with locally advanced prostate cancer. The ultimate utility of this approach remains undefined; however, additional study of this paradigm with docetaxel in combination with agents that may augment its activity such as calcitriol and velcade or other novel single agents seems warranted.25, 26
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This study was supported in part by a grant from Aventis Pharmaceuticals.
R. Dreicer is a study investigator funded by Aventis, Millenium, Berlex, and Celgene and is a member of the speaker's bureau for Aventis. E. A. Klein is a paid consultant to Aventis.