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Impact of Dietary Intervention in Men With Hormone Refractory Prostate Cancer


Phase 1
N/A
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

Impact of Dietary Intervention in Men With Hormone Refractory Prostate Cancer


OBJECTIVES:

- Determine whether a behavior-based dietary intervention can motivate patients with
hormone-refractory prostate cancer to adopt and maintain a dietary pattern that
includes < 20% of energy from fat, > 25 g of fiber, and 80 g of soy protein powder.

- Compare bioavailable levels of testosterone in patients treated with a behavior-based
dietary intervention vs observation only.

- Determine whether this dietary intervention decreases or stabilizes a rising serum
prostate-specific antigen level in these patients.

- Determine whether this dietary intervention improves disease-specific survival,
mediated by reduced bioavailable levels of testosterone, in these patients.

- Determine the impact of a positive intervention outcome on androgen receptors in
patients treated with this dietary intervention.

OUTLINE: This is a randomized, controlled, pilot, multicenter study. Patients are randomized
to 1 of 2 treatment arms.

All patients receive nutritional counseling on a healthy diet. Patients also keep a food
diary during study participation.

- Arm I (dietary intervention): Patients receive dietary intervention comprising
nutritional counseling on a low-fat, high-fiber, soy supplemented diet and
behavior-based activities, such as goal-setting, contracting, and stimulus control,
once weekly for 6 weeks, every 3 weeks for 33 weeks, and then at weeks 44, 48, and 52.
Treatment continues in the absence of disease progression or unacceptable toxicity.

- Arm II (observation): Patients undergo observation every 6 weeks for 36 weeks and then
every 8 weeks for 18 weeks.

PROJECTED ACCRUAL: A total of 92 patients (46 per treatment arm) will be accrued for this
study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma of the prostate

- No small cell component

- No histologically confirmed and/or demonstrable metastatic or locally recurrent
disease by bone scan, chest x-ray, computed tomography (CT) scan, or transrectal
ultrasound

- No clinical symptoms within the past 90 days

- Documented biochemical failure after radical prostatectomy

- Prostate-specific antigen must have initially nadired to an undetectable level
(< 0.1 ng/mL) after prostatectomy AND is currently rising (0.3-40.0 ng/mL)

- Serum testosterone > 100 ng/dL

PATIENT CHARACTERISTICS:

Age

- Any age

Performance status

- Zubrod 0-1

Life expectancy

- At least 1 year

Hematopoietic

- Not specified

Hepatic

- Not specified

Renal

- Not specified

Other

- No known allergic reactions to milk or soy products

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- More than 1 year since prior chemotherapy

Endocrine therapy

- More than 1 year since prior hormonal therapy

Radiotherapy

- Not specified

Surgery

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

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

Principal Investigator

Richard J. Babaian, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

CDR0000355833

NCT ID:

NCT00082732

Start Date:

July 2002

Completion Date:

February 2006

Related Keywords:

  • Prostate Cancer
  • stage I prostate cancer
  • stage II prostate cancer
  • adenocarcinoma of the prostate
  • Prostatic Neoplasms

Name

Location

University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009