OncologyPhase II Study of Nitric Oxide Donor for Men With Increasing Prostate-specific Antigen Level After Surgery or Radiotherapy for Prostate Cancer
Section snippets
Material and Methods
This study was a prospective Phase II, open-label clinical trial of men with PSA recurrence after primary treatment of prostate cancer. The patients were enrolled from May 2001 to June 2004. The institutional review board of Queen's University reviewed and approved the study, which was investigator initiated, without industry sponsorship.
The patients included in the present study were those who had undergone previous treatment with definitive radiotherapy (n = 10) or radical prostatectomy (n =
Results
Of the 29 patients enrolled in the study, 17 (58%) completed the entire 24 months of the study medication. Only 3 of the 29 patients (10%) had documented disease progression at 3, 9, and 21 months during the trial. Of these 3 patients, 2 had documented asymptomatic bony metastases on bone scan performed for suspicious PSADTs. One patient had bony metastases confirmed on magnetic resonance imaging 3 months after initiation of the study. Magnetic resonance imaging was performed for an equivocal
Comment
PSA is widely accepted as the most useful prognostic marker of prostate cancer progression, particularly after primary therapy with radical surgery or radiotherapy.17 Despite the improved cancer control rates with definitive management of early-stage prostate cancer, PSA recurrence is common (25%-50%) in most large case series.2, 3, 4 However, given the generally prolonged natural history of prostate cancer, this biochemical recurrence predates radiologic or clinical evidence of disease by a
Conclusions
The results of our study suggest that low-dose GTN has a consistent, inhibitory effect on PSA progression in men with recurrent prostate cancer after primary treatment failure. These significant effects on the slowing, and even stabilization, of the PSADT suggest a non-random drug effect of GTN. Implementation of strategies that could prolong the PSADT, thereby delaying the time to treatment with hormonal therapy and to death, would be of great benefit to patients. Our findings appear to
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