Tracks 1-8
DR MOUL: The dilemma we were facing with this patient was that although
he had high-grade disease and extracapsular extension, his margins were
negative. Theoretically, we had eliminated the primary tumor and had
negative margins, and there was some uncertainty as to whether we would
benefit from postoperative radiation therapy with negative margins.
The thinking was, because he had Gleason 5 + 3 disease with negative
margins, if he failed, we would be more likely to be dealing with a systemic
failure than a local failure. So we offered him the CALGB-99904 study, which
was a Phase III trial that randomly assigned patients to hormonal therapy with
mitoxantrone/prednisone versus hormonal therapy alone. We talked to him
about the trial either late June or July of 2005.
DR LOVE: It’s interesting historically because that’s when the docetaxel data
were just being presented (Petrylak 2004; Tannock 2004; [1.8]). They led to
adjuvant trials that continue to evaluate docetaxel. But at that point, CALGB-
99904 was the only adjuvant chemotherapy trial occurring in the United States.
DR MOUL: Exactly. He enrolled in the trial and was randomly assigned to the
hormonal therapy with chemotherapy arm.
DR LOVE: If this man had not been eligible for the study, would you have administered
hormone therapy, or would you have waited for his PSA level to rise?
DR MOUL: I’ve treated patients both ways. I would have counseled him that
the hormone therapy in the control arm of this study lasted two years, and it
would therefore have been reasonable off protocol to consider two years of
hormonal therapy.
DR LOVE: What do you think about the next generation of adjuvant trials
evaluating docetaxel?
DR MOUL: At Duke, we have recently started a trial with Dana-Farber using
docetaxel with bevacizumab neoadjuvantly prior to radical prostatectomy. We have a second trial in the adjuvant setting for patients who have already been
through surgery — the ASCENT trial.
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