Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Behavior-Based Dietary Intervention in Treating Patients With Hormone-Refractory Prostate Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Behavioral study, Treatment Closed Any age NCI MDA-DM-98054 NCT00082732

Special Category: SPORE trial

Objectives

1. 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.
2. Compare bioavailable levels of testosterone in patients treated with a behavior-based dietary intervention vs observation only.
3. Determine whether this dietary intervention decreases or stabilizes a rising serum prostate-specific antigen level in these patients.
4. Determine whether this dietary intervention improves disease-specific survival, mediated by reduced bioavailable levels of testosterone, in these patients.
5. Determine the impact of a positive intervention outcome on androgen receptors in patients treated with this dietary intervention.

Entry 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, 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

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

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Richard Babaian, MD, Principal investigator		Ph: 713-745-2645; 800-392-1611 Email: rbabaian@mdanderson.org

Registry Information
Official Title		Impact of Dietary Intervention in Men with Hormone Refractory Prostate Cancer
Trial Start Date		2002-07-28
Registered in ClinicalTrials.gov		NCT00082732
Date Submitted to PDQ		2003-11-11
Information Last Verified		2004-05-11
NCI Grant/Contract Number		P30-CA16672, P50-CA90270

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