Trial Outcomes & Findings for Diet in Altering Disease Progression in Patients With Prostate Cancer on Active Surveillance (NCT NCT01238172)
NCT ID: NCT01238172
Last Updated: 2023-03-21
Results Overview
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).
COMPLETED
PHASE3
478 participants
Up to 2 years
2023-03-21
Participant Flow
Of 602 total patients were pre-registered, only 478 patients were deemed eligible and randomized.
Participant milestones
| Measure |
Arm A - MEAL Program Intervention
Patients will receive dietary education and telephone counseling sessions over 24 months.
|
Arm B - Prostate Cancer Foundation Booklet
Patients receive education material about diet, nutrition, exercise and cancer.
|
|---|---|---|
|
Overall Study
STARTED
|
237
|
241
|
|
Overall Study
COMPLETED
|
226
|
217
|
|
Overall Study
NOT COMPLETED
|
11
|
24
|
Reasons for withdrawal
| Measure |
Arm A - MEAL Program Intervention
Patients will receive dietary education and telephone counseling sessions over 24 months.
|
Arm B - Prostate Cancer Foundation Booklet
Patients receive education material about diet, nutrition, exercise and cancer.
|
|---|---|---|
|
Overall Study
Ineligible: based on Eligibility Review
|
2
|
5
|
|
Overall Study
Ineligible: based on Central Path Review
|
9
|
19
|
Baseline Characteristics
Diet in Altering Disease Progression in Patients With Prostate Cancer on Active Surveillance
Baseline characteristics by cohort
| Measure |
Arm A - MEAL Program Intervention
n=226 Participants
Patients will receive dietary education and telephone counseling sessions over 24 months.
|
Arm B - Prostate Cancer Foundation Booklet
n=217 Participants
Patients receive education material about diet, nutrition, exercise and cancer.
|
Total
n=443 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.7 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
63.5 years
STANDARD_DEVIATION 6.6 • n=7 Participants
|
63.6 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
226 Participants
n=5 Participants
|
217 Participants
n=7 Participants
|
443 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
24 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
186 Participants
n=5 Participants
|
171 Participants
n=7 Participants
|
357 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
226 Participants
n=5 Participants
|
217 Participants
n=7 Participants
|
443 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
28.7 kg/m2
STANDARD_DEVIATION 5.9 • n=5 Participants
|
28.3 kg/m2
STANDARD_DEVIATION 3.7 • n=7 Participants
|
28.5 kg/m2
STANDARD_DEVIATION 4.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: 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.
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).
Outcome measures
| Measure |
Arm A - MEAL Program Intervention
n=226 Participants
Patients will receive dietary education and telephone counseling sessions over 24 months.
|
Arm B - Prostate Cancer Foundation Booklet
n=217 Participants
Patients receive education material about diet, nutrition, exercise and cancer.
|
|---|---|---|
|
Time to Progression
|
683.0 days
Interval 471.0 to 733.0
|
549.0 days
Interval 418.0 to 728.0
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: 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.
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.
Outcome measures
| Measure |
Arm A - MEAL Program Intervention
n=226 Participants
Patients will receive dietary education and telephone counseling sessions over 24 months.
|
Arm B - Prostate Cancer Foundation Booklet
n=217 Participants
Patients receive education material about diet, nutrition, exercise and cancer.
|
|---|---|---|
|
Time to Treatment: Censoring Death, Progression or Last Follow-up as Measured by Number of Events Observed
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: modified ITT population: Only participants with available data on the individual study measure at baseline and 24 months were included in the analysis.
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
Outcome measures
| Measure |
Arm A - MEAL Program Intervention
n=150 Participants
Patients will receive dietary education and telephone counseling sessions over 24 months.
|
Arm B - Prostate Cancer Foundation Booklet
n=140 Participants
Patients receive education material about diet, nutrition, exercise and cancer.
|
|---|---|---|
|
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
Interval -39.5 to 41.9
|
2.8 score on a scale
Interval -42.3 to 34.3
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Participants with available data on the individual study measure at baseline and 24 months were included in the analysis
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.
Outcome measures
| Measure |
Arm A - MEAL Program Intervention
n=233 Participants
Patients will receive dietary education and telephone counseling sessions over 24 months.
|
Arm B - Prostate Cancer Foundation Booklet
n=240 Participants
Patients receive education material about diet, nutrition, exercise and cancer.
|
|---|---|---|
|
Total Vegetables (Servings Per Day) Evaluated at Baseline and Month 24 Based on Dietary Recall
|
2.01 servings per day
Interval 1.75 to 2.28
|
0.37 servings per day
Interval 0.11 to 0.62
|
Adverse Events
Arm A - MEAL Program Intervention
Arm B - Prostate Cancer Foundation Booklet
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place