Prostate Adenocarcinoma, Stage IIA Prostate Cancer AJCC v7, Stage I Prostate Cancer AJCC V7
Conditions
Brief summary
This randomized phase III trial studies a diet and exercise program based on the Diabetes Prevention Program to promote weight loss and improve health in men with low-risk or low-intermediate-risk prostate cancer on active surveillance. A lifestyle intervention that promotes weight loss may influence prostate health. A combined diet and exercise program that is based on the Diabetes Prevention Program may affect markers (or biomarkers) of prostate cancer progression. Gathering this information may help doctors understand how obesity affects prostate cancer progression and may help lead to a program that can reduce the risk of prostate cancer progression.
Detailed description
PRIMARY OBJECTIVES: I. To test whether the Diabetes Prevention Program (DPP) lifestyle intervention (versus \[vs.\] control) improves serum fasting glucose. II. To test whether the DPP lifestyle intervention (vs. control) improves serum biomarkers of glucose regulation (insulin, C-peptide, insulin-like growth factor-1 \[IGF-1\], IGF binding protein 3 \[IGF-BP3\] and adiponectin). III. To test whether the DPP lifestyle intervention decreases the levels of insulin receptor or insulin-like growth factor-1 receptor (IGF-1R) in prostate cancer (PCa) tissue epithelium on follow-up prostate biopsy. IV. To test whether PCa patients randomized to the DPP lifestyle intervention sustain the lifestyle changes for at least 6 months after the end of the intervention period. SECONDARY OBJECTIVES: I. To evaluate whether the DPP lifestyle intervention improves health-related quality of life. II. To evaluate whether the DPP lifestyle intervention effects on pathologic features of follow-up prostate biopsies. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients meet with a nutritionist 11 times during the first 6 months to receive the structured diet and exercise instruction. Participants complete exercise sessions supervised by an exercise specialist, and will wear a heart rate monitor periodically during the study. ARM II: Patients receive oral and written information based on general U.S. dietary and physical activity guidelines along with a 20-30 minute individual session with a dietitian and a goal of 30 minutes of physical activity 5 days a week. After completion of study, patients are followed up at 3, 6, and 12 months.
Interventions
BEHAVIORALBehavioral Dietary Intervention
Undergo DPP lifestyle intervention
BEHAVIORALExercise Intervention
Undergo DPP lifestyle intervention
OTHERInformational Intervention
Receive oral and written guidelines and meet with dietician
OTHERLaboratory Biomarker Analysis
Correlative studies
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
National Cancer Institute (NCI)
Fred Hutchinson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed adenocarcinoma of the prostate, clinically localized, low or low-intermediate risk disease (T1C/T2a, Gleason =\< 7 \[3+4\], prostate-specific antigen \[PSA\] \< 20) * Primary treatment is active surveillance (AS) with planned annual surveillance biopsies * Body mass index (BMI) \>= 25 kg/m\^2; and * Physically able to undertake a diet and exercise program
Exclusion criteria
* Current, recent (\< 1 year), or planning to join a weight loss program or take appetite suppressants * Steroid hormone use (antiandrogen therapy \[ADT\]) within the past 12 months * Significant cardiovascular disease precluding an exercise program, including recent (within 6 months) myocardial infarction or stroke, pulmonary edema, myocarditis, pericarditis, unstable angina, pulmonary embolism/deep venous thrombosis (PE/DVT), uncontrolled hypertension (systolic blood pressure \[SBP\] \> 200; diastolic blood pressure \[DBP\] \> 110), uncontrolled arrhythmia, heart failure; or * Insulin dependent diabetes mellitus (DM) and/or metformin use * Doctor of medicine (MD) confirmed cognitive impairment * Current alcohol or narcotic abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Fasting Glucose at 6 Months | Baseline to 6 months | Mean and standard deviation of change from baseline. |
| Change From Baseline in Fasting C-peptide, IGF-1, IGF-BP3, and Adiponectin at 6 Months | Baseline to 6 months | Mean and standard deviation of change from baseline. |
| Change in Expression of Insulin Receptor (IR), IGF-1R, and Protein Kinase B (AKT) on Prostate Cancer Epithelial Cells | Baseline (6 months prior to randomization) to follow-up surveillance biopsy (6 months post-randomization) | Mean and standard deviation of change from baseline. |
| Weight at 12 Months | 12 months (6 months after active intervention) | Mean and standard deviation of weight at 12 months |
| Change From Baseline in Fasting Insulin at 6 Months | Baseline to 6 months | Mean and standard deviation of change from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health Related Quality of Life (HRQOL) at 6 Months | 6 months | Mean and standard deviation of Quality of Life measures at 6 months. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm I (Diet and Exercise Lifestyle Intervention) The goals of the diet and exercise lifestyle intervention is for patients to lose 7% total body weight. Patients meet with a nutritionist 11 times during the first 6 months to receive the structured diet and exercise instruction. Participants complete exercise sessions supervised by an exercise specialist, and will wear a heart rate monitor periodically during the study.
Behavioral Dietary Intervention: Undergo DPP lifestyle intervention
Exercise Intervention: Undergo DPP lifestyle intervention
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies | 58 |
| Arm II (Control) Patients receive an informational intervention along with a 20-30 minute individual session with a dietitian and a goal of 30 minutes of physical activity 5 days a week.
Informational Intervention: Receive oral and written guidelines and meet with dietician
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies | 59 |
| Total | 117 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Discontinued Active surveillance and underwent treatment | 1 | 2 |
| Overall Study | Lost to Follow-up | 4 | 7 |
| Overall Study | Withdrawal by Subject | 3 | 0 |
Baseline characteristics
| Characteristic | Arm I (Diet and Exercise Lifestyle Intervention) | Arm II (Control) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 35 Participants | 36 Participants | 71 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants | 23 Participants | 46 Participants |
| Age, Continuous | 66.6 years | 67.0 years | 66.6 years |
| Glucose | 73.5 mg/dL STANDARD_DEVIATION 19.1 | 76.0 mg/dL STANDARD_DEVIATION 24.3 | 74.8 mg/dL STANDARD_DEVIATION 21.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) White | 48 Participants | 51 Participants | 99 Participants |
| Region of Enrollment United States | 58 participants | 59 participants | 117 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 58 Participants | 59 Participants | 117 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 58 | 0 / 59 |
| other Total, other adverse events | 17 / 58 | 6 / 59 |
| serious Total, serious adverse events | 0 / 58 | 0 / 59 |
Outcome results
Primary
Change From Baseline in Fasting C-peptide, IGF-1, IGF-BP3, and Adiponectin at 6 Months
Mean and standard deviation of change from baseline.
Time frame: Baseline to 6 months
Population: Participants who completed the 6 month study visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I (Diet and Exercise Lifestyle Intervention) | Change From Baseline in Fasting C-peptide, IGF-1, IGF-BP3, and Adiponectin at 6 Months | C-peptide (ng/mL) | -0.55 ng/ml | Standard Deviation 0.72 |
| Arm I (Diet and Exercise Lifestyle Intervention) | Change From Baseline in Fasting C-peptide, IGF-1, IGF-BP3, and Adiponectin at 6 Months | IGF-1 (ng/mL) | 6.2 ng/ml | Standard Deviation 54 |
| Arm I (Diet and Exercise Lifestyle Intervention) | Change From Baseline in Fasting C-peptide, IGF-1, IGF-BP3, and Adiponectin at 6 Months | IGF-BP3 (ng/mL) | -363 ng/ml | Standard Deviation 818 |
| Arm I (Diet and Exercise Lifestyle Intervention) | Change From Baseline in Fasting C-peptide, IGF-1, IGF-BP3, and Adiponectin at 6 Months | Adiponectin (ng/mL) | 696 ng/ml | Standard Deviation 3124 |
| Arm II (Control) | Change From Baseline in Fasting C-peptide, IGF-1, IGF-BP3, and Adiponectin at 6 Months | Adiponectin (ng/mL) | 4.2 ng/ml | Standard Deviation 1652 |
| Arm II (Control) | Change From Baseline in Fasting C-peptide, IGF-1, IGF-BP3, and Adiponectin at 6 Months | C-peptide (ng/mL) | 0.06 ng/ml | Standard Deviation 0.65 |
| Arm II (Control) | Change From Baseline in Fasting C-peptide, IGF-1, IGF-BP3, and Adiponectin at 6 Months | IGF-BP3 (ng/mL) | -297 ng/ml | Standard Deviation 881 |
| Arm II (Control) | Change From Baseline in Fasting C-peptide, IGF-1, IGF-BP3, and Adiponectin at 6 Months | IGF-1 (ng/mL) | -4.7 ng/ml | Standard Deviation 51 |
Primary
Change From Baseline in Fasting Glucose at 6 Months
Mean and standard deviation of change from baseline.
Time frame: Baseline to 6 months
Population: Participants that completed the 6 month visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm I (Diet and Exercise Lifestyle Intervention) | Change From Baseline in Fasting Glucose at 6 Months | -3.65 mg/dL | Standard Deviation 21 |
| Arm II (Control) | Change From Baseline in Fasting Glucose at 6 Months | 4.5 mg/dL | Standard Deviation 47 |
Primary
Change From Baseline in Fasting Insulin at 6 Months
Mean and standard deviation of change from baseline.
Time frame: Baseline to 6 months
Population: Participants who completed the 6 month study visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm I (Diet and Exercise Lifestyle Intervention) | Change From Baseline in Fasting Insulin at 6 Months | -2.3 mUI/L | Standard Deviation 4.9 |
| Arm II (Control) | Change From Baseline in Fasting Insulin at 6 Months | -0.19 mUI/L | Standard Deviation 4.6 |
Primary
Change in Expression of Insulin Receptor (IR), IGF-1R, and Protein Kinase B (AKT) on Prostate Cancer Epithelial Cells
Mean and standard deviation of change from baseline.
Time frame: Baseline (6 months prior to randomization) to follow-up surveillance biopsy (6 months post-randomization)
Population: Data were not collected due to lack of funding.
Primary
Weight at 12 Months
Mean and standard deviation of weight at 12 months
Time frame: 12 months (6 months after active intervention)
Population: Participants who completed the month 12 study visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm I (Diet and Exercise Lifestyle Intervention) | Weight at 12 Months | 90.0 kilograms | Standard Deviation 14.3 |
| Arm II (Control) | Weight at 12 Months | 99.2 kilograms | Standard Deviation 20.1 |
Secondary
Health Related Quality of Life (HRQOL) at 6 Months
Mean and standard deviation of Quality of Life measures at 6 months.
Time frame: 6 months
Population: Participants who completed the 6 month study visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I (Diet and Exercise Lifestyle Intervention) | Health Related Quality of Life (HRQOL) at 6 Months | Overall Anxiety (MAX-PC); range 0-54, higher score indicates more anxiety | 16.9 score on a scale | Standard Deviation 7.5 |
| Arm I (Diet and Exercise Lifestyle Intervention) | Health Related Quality of Life (HRQOL) at 6 Months | Urinary Quality of Life (EPIC-26); range 0-100, higher score indicates better urinary QOL | 88.1 score on a scale | Standard Deviation 11.6 |
| Arm II (Control) | Health Related Quality of Life (HRQOL) at 6 Months | Urinary Quality of Life (EPIC-26); range 0-100, higher score indicates better urinary QOL | 82.9 score on a scale | Standard Deviation 12.7 |
| Arm II (Control) | Health Related Quality of Life (HRQOL) at 6 Months | Overall Anxiety (MAX-PC); range 0-54, higher score indicates more anxiety | 16.6 score on a scale | Standard Deviation 6.3 |