An interventional study of Behavioral Dietary Intervention and Exercise Intervention in Prostate Adenocarcinoma, Stage I Prostate Cancer AJCC V7 and Stage IIA Prostate Cancer AJCC v7, sponsored by Fred Hutchinson Cancer Center. Terminated at 1 site in United States. Open to male participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2023-01-04.
Sponsored by Fred Hutchinson Cancer Center · Not applicable, Interventional, and Supportive care
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.
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 117 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Fred Hutchinson Cancer Center is the lead sponsor of 537 studies on the registry; 79 are open to participants now.
Of its 57 completed or terminated interventional studies of FDA-regulated products, 45 (79%) have results posted.
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Exclusion Criteria:
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: Behavioral Dietary Intervention · Behavioral: Exercise Intervention · Other: Laboratory Biomarker Analysis · Other: Quality-of-Life Assessment · Other: Questionnaire Administration
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.
Other: Informational Intervention · Other: Laboratory Biomarker Analysis · Other: Quality-of-Life Assessment · Other: Questionnaire Administration
Undergo DPP lifestyle intervention
Undergo DPP lifestyle intervention
Receive oral and written guidelines and meet with dietician
Correlative studies
Ancillary studies
Also known as: Quality of Life Assessment
Ancillary studies
Change From Baseline in Fasting Glucose at 6 Months
Mean and standard deviation of change from baseline.
Time frame: Baseline to 6 months
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
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)
Weight at 12 Months
Mean and standard deviation of weight at 12 months
Time frame: 12 months (6 months after active intervention)
Change From Baseline in Fasting Insulin at 6 Months
Mean and standard deviation of change from baseline.
Time frame: Baseline to 6 months
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
| Milestone | Arm I (Diet and Exercise Lifestyle Intervention) | Arm II (Control) |
|---|---|---|
| Started | 58 | 59 |
| Completed | 50 | 50 |
| Not completed | 8 | 9 |
| Withdrew: Withdrawal by subject | 3 | 0 |
| Withdrew: Lost to follow-up | 4 | 7 |
| Withdrew: Discontinued active surveillance and underwent treatment | 1 | 2 |
Mean and standard deviation of change from baseline.
| mg/dL | Arm I (Diet and Exercise Lifestyle Intervention) | Arm II (Control) |
|---|---|---|
| Change From Baseline in Fasting Glucose at 6 Months | -3.65 ± 21 | 4.5 ± 47 |
Mean and standard deviation of change from baseline.
| ng/ml | Arm I (Diet and Exercise Lifestyle Intervention) | Arm II (Control) |
|---|---|---|
| C-peptide (ng/mL) | -0.55 ± 0.72 | 0.06 ± 0.65 |
| IGF-BP3 (ng/mL) | -363 ± 818 | -297 ± 881 |
| IGF-1 (ng/mL) | 6.2 ± 54 | -4.7 ± 51 |
| Adiponectin (ng/mL) | 696 ± 3124 | 4.2 ± 1652 |
Mean and standard deviation of change from baseline.
No measurements were reported for this outcome.
Mean and standard deviation of weight at 12 months
| kilograms | Arm I (Diet and Exercise Lifestyle Intervention) | Arm II (Control) |
|---|---|---|
| Weight at 12 Months | 90.0 ± 14.3 | 99.2 ± 20.1 |
Mean and standard deviation of change from baseline.
| mUI/L | Arm I (Diet and Exercise Lifestyle Intervention) | Arm II (Control) |
|---|---|---|
| Change From Baseline in Fasting Insulin at 6 Months | -2.3 ± 4.9 | -0.19 ± 4.6 |
Mean and standard deviation of Quality of Life measures at 6 months.
| score on a scale | Arm I (Diet and Exercise Lifestyle Intervention) | Arm II (Control) |
|---|---|---|
| Overall Anxiety (MAX-PC); range 0-54, higher score indicates more anxiety | 16.9 ± 7.5 | 16.6 ± 6.3 |
| Urinary Quality of Life (EPIC-26); range 0-100, higher score indicates better urinary QOL | 88.1 ± 11.6 | 82.9 ± 12.7 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm I (Diet and Exercise Lifestyle Intervention) | 0/58 (0%) | 0/58 (0%) | 17/58 (29.3%) |
| Arm II (Control) | 0/59 (0%) | 0/59 (0%) | 6/59 (10.2%) |
| Event | Arm I (Diet and Exercise Lifestyle Intervention) | Arm II (Control) |
|---|---|---|
| ArthralgiaInjury, poisoning and procedural complications | 7/58 | 0/59 |
| Back painMusculoskeletal and connective tissue disorders | 3/58 | 0/59 |
| FallInjury, poisoning and procedural complications | 1/58 | 0/59 |
| Wound dehiscenceInjury, poisoning and procedural complications | 1/58 | 0/59 |
| Back surgeryMusculoskeletal and connective tissue disorders | 1/58 | 0/59 |
| Transurethral resection of the prostateSurgical and medical procedures | 1/58 | 0/59 |
| Rectal hemorrhageInjury, poisoning and procedural complications | 1/58 | 1/59 |
| Cystitis, non-infectiveInjury, poisoning and procedural complications | 1/58 | 1/59 |
| Shin splintsMusculoskeletal and connective tissue disorders | 1/58 | 0/59 |
| Atrioventricular block, 2nd degreeCardiac disorders | 1/58 | 0/59 |
| Age, Categorical(Participants) | Arm I (Diet and Exercise Lifestyle Intervention) | Arm II (Control) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 23 | 23 | 46 |
| >=65 years | 35 | 36 | 71 |
| Age, Continuous(years) | Arm I (Diet and Exercise Lifestyle Intervention) | Arm II (Control) | Total |
|---|---|---|---|
| Median | 66.6 (61.7 to 71.2) | 67.0 (61.8 to 69.9) | 66.6 (61.7 to 70.7) |
| Sex: Female, Male(Participants) | Arm I (Diet and Exercise Lifestyle Intervention) | Arm II (Control) | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 58 | 59 | 117 |
| Race (NIH/OMB)(Participants) | Arm I (Diet and Exercise Lifestyle Intervention) | Arm II (Control) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 5 | 2 | 7 |
| White | 48 | 51 | 99 |
| More than one race | 1 | 3 | 4 |
| Unknown or Not Reported | 2 | 2 | 4 |
| Region of Enrollment(participants) | Arm I (Diet and Exercise Lifestyle Intervention) | Arm II (Control) | Total |
|---|---|---|---|
| United States | 58 | 59 | 117 |
| Glucose(mg/dL) | Arm I (Diet and Exercise Lifestyle Intervention) | Arm II (Control) | Total |
|---|---|---|---|
| Mean | 73.5 ± 19.1 | 76.0 ± 24.3 | 74.8 ± 21.8 |
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