Trial Information

A Diet, Physical Activity, and Meditation Intervention in Men With Rising Prostate-specific Antigen

Following surgery or radiation of a primary early-stage prostate cancer (PrCA), one in three
patients will experience an elevation in serum prostate antigen (PSA) within 10 years. For
men whose primary treatment was prostatectomy, a PSA rise virtually always signals the
spread of PrCA. After such evidence of recurrence, the "standard" treatment is medical or
surgical castration. Castration results in reducing the PSA about 85% of the time, but it
makes no difference whether such treatment occurs before or after the appearance of clinical
symptoms of recurrence. This time interval between the first rise in PSA and symptom
appearance may be many years. The most salient fact, however, is that castration does not
prolong men's lives and it is not certain whether it even meaningfully delays symptom
appearance in men who receive the treatment at the first sign of biochemical recurrence.
Castration also has significant side effects including osteoporosis (bone loss), decreased
muscle mass, impotence, and urinary incontinence. Because PrCA is usually a disease of
older men, many will succumb to other diseases before they ever develop a symptom related to
metastatic PrCA. For this large fraction of men, a treatment with deleterious affects on
quality of life and no clear overall survival benefit may not be a good choice. The
protocol the investigators propose will be performed instead of medical or surgical
castration, which is not medically indicated at this point in the course of PrCA. Castration
can and will be offered to these men at the first clinical symptom or sign of metastatic
cancer, at which time those men will come off this study. It also is important to note that
if the intervention results in reductions in PSA then the investigators will offer it to all
men who had been randomized to the control condition initially. The investigators will
conduct this randomized study in 60 asymptomatic men who have undergone radical
prostatectomy (removal of the prostate gland) as their primary therapy of biopsy-confirmed
adenocarcinoma of the prostate and subsequently have been found to have rising PSA levels,
indicating an early recurrence of the cancer. Half (30) of these men will be randomized to
usual care (watchful waiting) and the other half to an intervention consisting of a
vegetable-based diet, program of physical activity timed to the natural rhythm of the day
(i.e., circadian, or "around the day" - basically to timing of their exercise to improve
their sleep cycles), and mindfulness-based stress reduction (consisting of meditation and
other stress-reducing techniques). The intervention will continue for three months,
followed by monthly booster sessions for 9 months. Data will be collected on compliance
with the intervention and other factors that could modify the intervention or confuse our
interpretation of its effect. The overall goal of the study will be to see the effect of
making these behavioral and attitudinal changes on PSA levels, an indicator of disease
progression in these men. The therapies the investigators will study are completely
non-toxic and behavioral in nature.