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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-00686 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| RG1001233 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| R01CA184075 | U.S. NIH Grant/Contract | View source |
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Terminated due to insufficient funding
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (diet and exercise lifestyle intervention) | Experimental | 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. |
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| Arm II (control) | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Dietary Intervention | Behavioral | Undergo DPP lifestyle intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Fasting Glucose at 6 Months | Mean and standard deviation of change from baseline. | 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. | 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. | 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 | 12 months (6 months after active intervention) |
| Change From Baseline in Fasting Insulin at 6 Months | Mean and standard deviation of change from baseline. | Baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Health Related Quality of Life (HRQOL) at 6 Months | Mean and standard deviation of Quality of Life measures at 6 months. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Wright | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 dietitian11 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 20, 2020 |
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| Exercise Intervention | Behavioral | Undergo DPP lifestyle intervention |
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| Informational Intervention | Other | Receive oral and written guidelines and meet with dietician |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| FG001 | 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 dietitian. Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Glucose | Fasting Glucose | Mean | Standard Deviation | mg/dL |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Fasting Glucose at 6 Months | Mean and standard deviation of change from baseline. | Participants that completed the 6 month visit | Posted | Mean | Standard Deviation | mg/dL | Baseline to 6 months |
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| 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. | Participants who completed the 6 month study visit | Posted | Mean | Standard Deviation | ng/ml | Baseline to 6 months |
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| 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. | Data were not collected due to lack of funding. | Posted | Baseline (6 months prior to randomization) to follow-up surveillance biopsy (6 months post-randomization) |
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| Primary | Weight at 12 Months | Mean and standard deviation of weight at 12 months | Participants who completed the month 12 study visit | Posted | Mean | Standard Deviation | kilograms | 12 months (6 months after active intervention) |
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| Primary | Change From Baseline in Fasting Insulin at 6 Months | Mean and standard deviation of change from baseline. | Participants who completed the 6 month study visit | Posted | Mean | Standard Deviation | mUI/L | Baseline to 6 months |
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| Secondary | Health Related Quality of Life (HRQOL) at 6 Months | Mean and standard deviation of Quality of Life measures at 6 months. | Participants who completed the 6 month study visit | Posted | Mean | Standard Deviation | score on a scale | 6 months |
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6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I (Diet and Exercise Lifestyle Intervention) | Intervention based on the Diabetes Prevention Program for weight loss. Patients meet with a dietitian11 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. | 0 | 58 | 0 | 58 | 17 | 58 |
| EG001 | Arm II (Control) | General guidance on weight loss, healthy diet and physical activity provided in a single session (20 - 30 minutes). | 0 | 59 | 0 | 59 | 6 | 59 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Injury, poisoning and procedural complications | Non-systematic Assessment | Pain in joint |
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| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Wound dehiscence | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Back surgery | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Transurethral resection of the prostate | Surgical and medical procedures | Non-systematic Assessment |
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| Rectal hemorrhage | Injury, poisoning and procedural complications | Non-systematic Assessment | post prostate biopsy |
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| Cystitis, non-infective | Injury, poisoning and procedural complications | Non-systematic Assessment | post prostate biopsy |
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| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Rib |
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| Shin splints | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | Non-systematic Assessment | Asymptomatic, discovered on ECG |
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| Conduction disorder | Cardiac disorders | Non-systematic Assessment | Right bundle branch block; symptomatic, discovered on ECG |
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| Premature Ventricular Complex | Cardiac disorders | Non-systematic Assessment | Asymptomatic, discovered on ECG |
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| Atrioventricular block, 2nd degree | Cardiac disorders | Non-systematic Assessment | Asymptomatic, discovered on ECG |
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| Acute arrhythmia | Cardiac disorders | Non-systematic Assessment | Asymptomatic, discovered on ECG |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeannette M. Schenk, PhD | Fred Hutchinson Cancer Center | 206-667-6860 | jschenk@fredhutch.org |
| Sep 27, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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