Prostate Cancer
Conditions
Keywords
stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, adenocarcinoma of the prostate
Brief summary
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.
Detailed description
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.
Interventions
OTHERdietary education and counseling
OTHERprostate cancer foundation booklet
Sponsors
National Cancer Institute (NCI)
Alliance for Clinical Trials in Oncology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Preregistration Eligibility: 1. Histologic Documentation: * The initial biopsy showing diagnosis of prostate cancer should be used for the purposes of determining eligibility. * However, if a subsequent biopsy performed before patient enrollment shows that the patient is ineligible, he may not be enrolled to the study. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Progression | Up to 2 years | Time to progression (TTP) was defined as the length of time from the date of random assignment to progression; patients who died from any cause without experiencing disease progression were censored at the time of death. Disease progression is defined by (a) PSA doubling time (PSADT) less than 3 years, (b) PSA above 10 at any time, or (c) Gleason score on repeat biopsy ≥ 7 for men 70 years or younger and ≥ 4+3 = 7 for men older than 70 years. For the primary analysis, TTP was analyzed using the Kaplan-Meier method; the log-rank test was used to determine superiority of the intervention arm (Arm A: MEAL Program Intervention) compared with the control arm (Arm B: Prostate Cancer Foundation Booklet). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Treatment: Censoring Death, Progression or Last Follow-up as Measured by Number of Events Observed | Up to 2 years | Time to treatment was analyzed by the Kaplan-Meier method. For this analysis, patients who did not withdrawal from the study to pursue treatment were censored at the time of clinical progression, death, or their last follow-up visit, whichever occurred first. The number of patients who observed an event (treatment) are summarized below. |
| Quality of Life (QOL) Was Measured Using Change From Baseline in Total Summary Score of Memorial Anxiety Scale for Prostate Cancer (MAX-PC) at Month 24 | Up to 2 years | Quality of Life (QOL) was measured using Observed Total Summary Score of Memorial Anxiety Scale for Prostate Cancer \[MAX-PC\] at Month 24 on a 0-108 scale, with lower scores corresponding to worse overall QOL and higher scores corresponding to better overall QOL. MAX-PC is a prostate cancer-specific measure to assess patient anxiety due to prostate cancer, PSA tests and fears of recurrence. Change from baseline to month-24 was calculated by subtracting the baseline scores from the scores at month-24. Higher scores on MAX-PC indicate better QOL |
| Total Vegetables (Servings Per Day) Evaluated at Baseline and Month 24 Based on Dietary Recall | Up to 2 years | At baseline and 24 months, participant diet including total vegetables (servings/day) was measured with a series of three separate interviews at each time point, on three-randomly selected days in a single week, using the Nutrition Data Systems for Research (NDS-R, current version 2010, University of Minnesota Nutrition Coordinating Center, University of Minnesota, Minneapolis, MN) software and nutrient database. Total vegetables were measured as the number of servings per day (range: ≥ 0), where higher values correspond to more servings per day. The within-participant change from baseline at 24 months was calculated by subtracting the baseline number of servings per day from the number of servings per day at month 24; positive values correspond to increased consumption of total vegetables. |
Countries
United States
Participant flow
Pre-assignment details
Of 602 total patients were pre-registered, only 478 patients were deemed eligible and randomized.
Participants by arm
| Arm | Count |
|---|---|
| Arm A - MEAL Program Intervention Patients will receive dietary education and telephone counseling sessions over 24 months. | 226 |
| Arm B - Prostate Cancer Foundation Booklet Patients receive education material about diet, nutrition, exercise and cancer. | 217 |
| Total | 443 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Ineligible: based on Central Path Review | 9 | 19 |
| Overall Study | Ineligible: based on Eligibility Review | 2 | 5 |
Baseline characteristics
| Characteristic | Arm A - MEAL Program Intervention | Arm B - Prostate Cancer Foundation Booklet | Total |
|---|---|---|---|
| Age, Continuous | 63.7 years STANDARD_DEVIATION 6.5 | 63.5 years STANDARD_DEVIATION 6.6 | 63.6 years STANDARD_DEVIATION 6.5 |
| Body Mass Index (BMI) | 28.7 kg/m2 STANDARD_DEVIATION 5.9 | 28.3 kg/m2 STANDARD_DEVIATION 3.7 | 28.5 kg/m2 STANDARD_DEVIATION 4.9 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 6 Participants | 9 Participants | 15 Participants |
| Race/Ethnicity, Customized Black or African American | 24 Participants | 26 Participants | 50 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 9 Participants | 7 Participants | 16 Participants |
| Race/Ethnicity, Customized More than one race | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 186 Participants | 171 Participants | 357 Participants |
| Region of Enrollment United States | 226 Participants | 217 Participants | 443 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 226 Participants | 217 Participants | 443 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Time to Progression
Time to progression (TTP) was defined as the length of time from the date of random assignment to progression; patients who died from any cause without experiencing disease progression were censored at the time of death. Disease progression is defined by (a) PSA doubling time (PSADT) less than 3 years, (b) PSA above 10 at any time, or (c) Gleason score on repeat biopsy ≥ 7 for men 70 years or younger and ≥ 4+3 = 7 for men older than 70 years. For the primary analysis, TTP was analyzed using the Kaplan-Meier method; the log-rank test was used to determine superiority of the intervention arm (Arm A: MEAL Program Intervention) compared with the control arm (Arm B: Prostate Cancer Foundation Booklet).
Time frame: Up to 2 years
Population: The primary analysis was based on the modified intention-to-treat (m-ITT) analysis population. The m-ITT population included all randomized patients; however, patients who later became ineligible by eligibility review or centralized pathology review of their baseline tissue specimens were excluded.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A - MEAL Program Intervention | Time to Progression | 683.0 days |
| Arm B - Prostate Cancer Foundation Booklet | Time to Progression | 549.0 days |
p-value: 0.7695% CI: [0.75, 1.24]Log Rank
Secondary
Quality of Life (QOL) Was Measured Using Change From Baseline in Total Summary Score of Memorial Anxiety Scale for Prostate Cancer (MAX-PC) at Month 24
Quality of Life (QOL) was measured using Observed Total Summary Score of Memorial Anxiety Scale for Prostate Cancer \[MAX-PC\] at Month 24 on a 0-108 scale, with lower scores corresponding to worse overall QOL and higher scores corresponding to better overall QOL. MAX-PC is a prostate cancer-specific measure to assess patient anxiety due to prostate cancer, PSA tests and fears of recurrence. Change from baseline to month-24 was calculated by subtracting the baseline scores from the scores at month-24. Higher scores on MAX-PC indicate better QOL
Time frame: Up to 2 years
Population: modified ITT population: Only participants with available data on the individual study measure at baseline and 24 months were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm A - MEAL Program Intervention | Quality of Life (QOL) Was Measured Using Change From Baseline in Total Summary Score of Memorial Anxiety Scale for Prostate Cancer (MAX-PC) at Month 24 | 2.0 score on a scale |
| Arm B - Prostate Cancer Foundation Booklet | Quality of Life (QOL) Was Measured Using Change From Baseline in Total Summary Score of Memorial Anxiety Scale for Prostate Cancer (MAX-PC) at Month 24 | 2.8 score on a scale |
p-value: 0.995Wilcoxon (Mann-Whitney)
Secondary
Time to Treatment: Censoring Death, Progression or Last Follow-up as Measured by Number of Events Observed
Time to treatment was analyzed by the Kaplan-Meier method. For this analysis, patients who did not withdrawal from the study to pursue treatment were censored at the time of clinical progression, death, or their last follow-up visit, whichever occurred first. The number of patients who observed an event (treatment) are summarized below.
Time frame: Up to 2 years
Population: The m-ITT population included all randomized patients; however, patients who later became ineligible by eligibility review or centralized pathology review of their baseline tissue specimens were excluded.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A - MEAL Program Intervention | Time to Treatment: Censoring Death, Progression or Last Follow-up as Measured by Number of Events Observed | 3 Participants |
| Arm B - Prostate Cancer Foundation Booklet | Time to Treatment: Censoring Death, Progression or Last Follow-up as Measured by Number of Events Observed | 2 Participants |
p-value: 0.7195% CI: [0.23, 8.41]Log Rank
Secondary
Total Vegetables (Servings Per Day) Evaluated at Baseline and Month 24 Based on Dietary Recall
At baseline and 24 months, participant diet including total vegetables (servings/day) was measured with a series of three separate interviews at each time point, on three-randomly selected days in a single week, using the Nutrition Data Systems for Research (NDS-R, current version 2010, University of Minnesota Nutrition Coordinating Center, University of Minnesota, Minneapolis, MN) software and nutrient database. Total vegetables were measured as the number of servings per day (range: ≥ 0), where higher values correspond to more servings per day. The within-participant change from baseline at 24 months was calculated by subtracting the baseline number of servings per day from the number of servings per day at month 24; positive values correspond to increased consumption of total vegetables.
Time frame: Up to 2 years
Population: Participants with available data on the individual study measure at baseline and 24 months were included in the analysis
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm A - MEAL Program Intervention | Total Vegetables (Servings Per Day) Evaluated at Baseline and Month 24 Based on Dietary Recall | 2.01 servings per day |
| Arm B - Prostate Cancer Foundation Booklet | Total Vegetables (Servings Per Day) Evaluated at Baseline and Month 24 Based on Dietary Recall | 0.37 servings per day |
p-value: <0.001t-test, 2 sided