Alternative TherapyClinical Events in Prostate Cancer Lifestyle Trial: Results From Two Years of Follow-Up
Section snippets
Participants
The PCLT consisted of 93 men (mean age 66 ± 8 years) with biopsy-proven prostate cancer (Gleason score <7, PSA 4-10 ng/mL) who had chosen active surveillance and had been randomly assigned to either an experimental or a control group. The experimental group had been prescribed an intensive lifestyle program that included a vegan diet (supplemented with soy,14 fish oil, vitamin E, selenium, and vitamin C), moderate aerobic exercise (walking 30 minutes 6 days weekly), stress management techniques
Clinical Events
Information on clinical events was obtained for 92 of the 93 patients (99%). Event data were missing for 1 experimental patient. For 86 of the 92 patients (93%), the event information was obtained from review of both the study chart and the Health Events questionnaire. For the remaining 6 patients (7%), information was obtained from the study chart review only. Medical records were obtained when possible (93% obtained). Very strong agreement was found between the self-reported and
Comment
The purpose of this study was to assess the clinical events in the PCLT at 2 years after study entry. At 1 year, 0 experimental patients and 6 control patients had undergone conventional prostate cancer therapy.11 The present analyses revealed that this group difference in treatment was still maintained (if not enhanced) at the 2-year mark. Specifically, significantly fewer men in the experimental group had undergone conventional prostate cancer treatment (eg, radical prostatectomy,
Conclusions
The results of our study have shown that participating in an intensive lifestyle program might allow patients choosing active surveillance to delay conventional treatment. Because prostate cancer is often associated with a variable or prolonged natural history, longer follow-up is necessary to determine whether the apparent benefits of the lifestyle change program are maintained beyond 24 months and whether such an approach is safe with regard to cancer control.
Acknowledgment
To Damien McKnight and Caren Raisin for their assistance with data collection, Nancy Mendell for statistical advice, and Bryce Williams for his helpful comments; and to Speaker Nancy Pelosi, Representative John Murtha, and Senators Arlen Specter and Ted Stevens.
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This research was supported in part by a grant from the Department of the Army (U.S. Army Medical Research Acquisition Activity W81XWH-05-1-0375), the Department of Health and Human Services (Health Resources and Services Administration grant C76HF00803), Department of Defense Uniformed Services University (USU grant MDA905-99-1-0003) by way of the Henry M. Jackson Foundation (grant 600-06971000-236), Prostate Cancer Foundation, and National Institutes of Health grant 5P50CA089520-02 University of California, San Francisco, Prostate Cancer Specialized Program of Research Excellence) and in part by grants from Safeway, Incorporated, and the following foundations: Walton Family, Ellison, Fisher, Gallin, Highmark Blue Cross Blue Shield, Koch, Resnick, Wachner, and Wynn.
This research does not reflect the position or policy of the U.S. government. None of these agencies were involved in the design or conduct of the study, in the collection, analysis, or interpretation of the data, or in the preparation, review, or approval of the manuscript.