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Diet in Altering Disease Prog...

Diet in Altering Disease Progression in Patients With Prostate Cancer on Active Surveillance

Last Updated: 2023-03-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

478 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2019-01-15

Brief Summary

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RATIONALE: Eating a diet high in vegetables may slow down disease progression in patients with prostate cancer.

PURPOSE: This randomized clinical trial is studying how well diet works in altering disease progression in patients with prostate cancer on active surveillance.

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Detailed Description

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CALGB 70807 is a randomized, phase III clinical trial designed to test this practical, diet-based intervention for prostate cancer in a broader clinical setting. Patients on AS will be randomized either to an intervention of centralized, telephone-based dietary counseling and structured dietary education or to a comparison control condition in which they receive the Prostate Cancer Foundation booklet. Study endpoints will include disease progression, incidence of treatment, and health-related quality of life.

OBJECTIVES:

Primary

* To determine if a telephone-based dietary intervention compared to no intervention will decrease clinical progression in AS patients.

Secondary

* To compare the incidence of active treatment (surgery, irradiation, local ablation, or androgen deprivation) in AS patients receiving dietary intervention compared to no intervention.
* To compare prostate cancer-related anxiety in AS patients receiving dietary intervention compared to no intervention.
* To compare health-related quality of life in AS patients receiving dietary intervention compared to no intervention.

OUTLINE: This is a multicenter study. Patients are stratified according to age (≤ 70 years vs \> 70 years), race (black or african american vs other), and baseline prostate biopsy (0-12 months before registration vs \> 12-24 months before registration). Patients are randomized to 1 of 2 treatment arms. Please see the arms section for more information.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A - MEAL Program Intervention

Patients will receive dietary education and telephone counseling sessions over 24 months.

Group Type EXPERIMENTAL

dietary education and counseling

Intervention Type OTHER

Arm B - Prostate Cancer Foundation Booklet

Patients receive information about diet, nutrition, exercise and cancer. Patients also receive regularly scheduled newsletters.

Group Type EXPERIMENTAL

prostate cancer foundation booklet

Intervention Type OTHER

Interventions

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dietary education and counseling

Intervention Type OTHER

prostate cancer foundation booklet

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Eligible patients must meet all of the following criteria:

* Biopsy-proven (consisting of ≥ 10 tissue cores) adenocarcinoma of the prostate diagnosed within 24 months prior to pre-registration
* \< 25% of biopsy tissue cores positive for cancer
* ≤ 50% of any one biopsy tissue core positive for cancer
* Clinical stage ≤ T2a
* Patients who have prostate cancer with distant metastases are not eligible
* NOTE: If a patient undergoes a transurethral resection of the prostate (TURP) for benign prostatic hyperplasia (BPH), and prostate cancer is diagnosed incidentally from the TURP specimen, eligibility for CALGB 70807 cannot be determined from the TURP specimen. However, if the patient subsequently undergoes a minimum 10-core prostate biopsy within 2 years of prostate cancer diagnosis from the TURP, and prostate cancer is detected in the biopsy specimen and meets the requirements above, the patient is eligible for this study. If prostate cancer is not detected in the biopsy specimen, the patient is not eligible.
2. Prior Treatment: Patients who have had prior treatment for prostate cancer by surgery, irradiation, local ablative (i.e. cryosurgery or high-intensity focused ultrasound) or androgen deprivation therapy are not eligible.
3. Patients who have had a history of non-cutaneous malignancy (other than nonmelanoma skin cancer) in the previous 5 years are not eligible.
4. Language: Patients must be able to read and comprehend English language text and be able to understand spoken English over the phone.
5. Life expectancy of at least 3 years
6. Patients who are currently taking vitamin supplements including lycopene and beta-carotene are eligible.
7. Patients receiving treatment with 5-alpha reductase inhibitors (e.g., finasteride, dutasteride) within 90 days prior to preregistration are not eligible. Treatment with these agents during the protocol intervention is not permitted.
8. Patients who are currently taking coumadin are not eligible.
9. Participants will be men aged 50 to 80 years.
10. For men ≤ 70 years, biopsy Gleason score ≤ 6; for men \> 70 years, biopsy Gleason score ≤ (3 + 4) = 7.
11. Required Initial Laboratory Values:

* Serum PSA \< 10 ng/mL
* NOTE: Baseline PSA for determination of eligibility must be measured after discontinuation of any 5-alpha reductase inhibitors.

Registration Eligibility:

1. Successful completion of three 24-hour dietary recalls during the run-in period.
2. Patients consuming ≥ 6 servings per day of fruits and vegetables (not including juices), as determined by the run-in dietary recalls are not eligible.

Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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J. Kellogg Parsons, MD, MHS

Role: STUDY_CHAIR

University of California, San Diego

Locations

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Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital

Fairbanks, Alaska, United States

Site Status

Mayo Clinic Scottsdale

Scottsdale, Arizona, United States

Site Status

Kaiser Permanente Medical Center - Bellflower

Bellflower, California, United States

Site Status

California Cancer Care, Incorporated - Greenbrae

Greenbrae, California, United States

Site Status

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, United States

Site Status

Loma Linda University Cancer Institute at Loma Linda University Medical Center

Loma Linda, California, United States

Site Status

Kaiser Permanente Medical Center - Los Angeles

Los Angeles, California, United States

Site Status

Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status

Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego

San Diego, California, United States

Site Status

Naval Medical Center - San Diego

San Diego, California, United States

Site Status

Veterans Affairs Medical Center - San Diego

San Diego, California, United States

Site Status

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Site Status

Saint Helena Hospital

St. Helena, California, United States

Site Status

University of Colorado Cancer Center at UC Health Sciences Center

Aurora, Colorado, United States

Site Status

Poudre Valley Hospital

Fort Collins, Colorado, United States

Site Status

Front Range Cancer Specialists

Fort Collins, Colorado, United States

Site Status

Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

Hartford, Connecticut, United States

Site Status

Middlesex Hospital Cancer Center

Middletown, Connecticut, United States

Site Status

Tunnell Cancer Center at Beebe Medical Center

Lewes, Delaware, United States

Site Status

CCOP - Christiana Care Health Services

Newark, Delaware, United States

Site Status

Lakeland Regional Cancer Center at Lakeland Regional Medical Center

Lakeland, Florida, United States

Site Status

Florida Hospital Cancer Institute at Florida Hospital Orlando

Orlando, Florida, United States

Site Status