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

18 Years
Not Enrolling
Prostate Cancer

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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.

Inclusion Criteria:

- have a histologically confirmed diagnosis of adenocarcinoma of the prostate

- have been treated by radical prostatectomy or radiation therapy

- have had no malignancy in the past 5 years (except the primary prostate cancer for
which initial treatment was sought and non malignant melanoma of the skin)

- not be taking thyroid medication, antibiotics, diuretics or steroids

- be able to read at a sixth grade level

- speak English as their first language

- be of sound mind, memory, and understanding as evaluated by recruitment staff

- have experienced a rise in serum PSA concentration after achieving a post surgery
nadir, after achieving a post radiation nadir, or having had both a radical
prostatectomy and subsequent radiotherapy

Exclusion Criteria:

- has received high dose radiotherapy or brachytherapy in place of surgery as a primary

- has received post-operative hormone therapy for prostate cancer

- received treatment of prostate cancer with an LH-RH analog

- has a diagnosis of cardiovascular, pulmonary, or metabolic disease or major symptoms
of these diseases, including pain or discomfort in the chest, neck, jaw, arms or
other areas that may be due to ischemia; shortness of breath or unusual fatigue at
rest or with mild exertion; dizziness; dyspnea while sleeping; ankle edema or
intermittent claudication; palpitations, tachycardia, or a known heart murmur

- has experienced a weight loss in excess of five pounds in the previous 3 months

- regularly consumes more than two alcoholic drinks per day

- plans on taking hormone supplements such as melatonin, or fish oil or other;
supplements rich in omega-3 fatty acids

- has been diagnosed with Crohn's disease or has active ulcerative colitis

- has been diagnosed with Post Traumatic Stress Disorder (PTSD)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

Change in prostate-specific antigen from baseline

Outcome Description:

PSA is measured at baseline, 3 months and 6 months. Change in PSA is the primary outcome measure.

Outcome Time Frame:

baseline, 3 months, 6 months

Safety Issue:


Principal Investigator

James R Hebert, Sc.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of South Carolina


United States: Institutional Review Board

Study ID:




Start Date:

January 2003

Completion Date:

July 2007

Related Keywords:

  • Prostate Cancer
  • prostate cancer
  • Prostatic Neoplasms



Palmetto Richland Memorial HospitalColumbia, South Carolina  29203
Palmetto Baptist Medical CenterColumbia, South Carolina  29201