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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-01092 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| I-2980822 | Other Identifier | Roswell Park Cancer Institute |
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This clinical trial examines weight loss interventions in reducing cancer progression in prostate cancer patients under active surveillance. Intensive lifestyle interventions that recommend modest reductions in daily caloric intake (i.e. continuous calorie energy reduction [CER]) are the gold-standard for weight loss, and have been tested in cancer survivors, including prostate cancer patients. However, few interventions have been developed for low-risk prostate cancer patients on active surveillance. Intermittent fasting (IF) may be superior to CER in the context of prostate cancer progression given its dual role in weight loss and metabolic switching from the use of glucose as a fuel source to the use of fatty acids and ketone bodies. This study may help researchers determine which weight loss strategies can reduce their risk of prostate cancer recurrence, and other negative health effects of being overweight or obese.
PRIMARY OBJECTIVES:
I. Develop two evidence-based behavioral weight loss intervention programs (IF and CER) with a goal to cause weight loss in prostate cancer (PCa) patients on active surveillance (AS).
II. Determine the initial comparative effectiveness of two intervention programs (IF and CER) on weight loss and PCa progression outcomes.
SECONDARY OBJECTIVE:
I. Compare the effects of the interventions on biomarkers underlying obesity and PCa to provide mechanistic insights and potential surrogate biomarkers for PCa prognosis.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo the CER intervention consisting of remote lessons containing information and behavioral strategies about weight loss, session with study interventionist to review lessons, and self-monitoring of body weight, physical activity and dietary intake. Patients also undergo collection of blood samples throughout the trial.
ARM II: Patients undergo IF intervention consisting of remote lesson containing information and behavioral strategies about fasting, session with study interventionist to review lessons, and self-monitoring of fasting. Patients will undergo fasting 2 days per week and eat according to the National Cancer Institute (NCI) guidelines the remaining 5 days. Patients also undergo collection of blood samples throughout the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (CER) | Active Comparator | Patients undergo CER intervention consisting of remote lesson containing information and behavioral strategies about weight loss, session with study interventionist to review lessons, and self-monitoring of body weight. Patients also undergo collection of blood samples throughout the trial. |
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| Arm II (IF) | Experimental | Patients undergo IF intervention consisting of remote lesson containing information and behavioral strategies about fasting, session with study interventionist to review lessons, and self-monitoring of body weight. Patients also undergo fasting 2 days per week and eat according to the NCI guidelines the remaining 5 days. Patients also undergo collection of blood samples throughout the trial. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo collection of blood samples |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Body weight | Weight will be measured using a body composition monitor. | Up to 6 months |
| Changes in prostate cancer (PCa) progression | Will assess changes in PCa progression indicated by serum prostate specific antigen (PSA) doubling time, and biopsy tumor upgrading and/or upstaging if required clinically, between the timepoints prior and post to the intervention. The timing of the intervention and data collection visits will be scheduled to correspond with the PCa patient's regular management check-up with their physician to allow their scheduled PSA test fall within at least a 6-month time window. For patients if prostate biopsy per clinical guidance is scheduled within 6 months after the intervention, the results from the biopsy post to the intervention as well as the nearest biopsy prior to the intervention will be requested. PSA test results (level and doubling time) and pathology reports on biopsies tissues (stage and grade) will be requested from the Biomedical Research Informatics Shared Resource for both baseline and follow-up visits and defined based on clinical criteria. | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Dietary intake | Will confirm the extent changes in body weight are due to changes in caloric intake. Dietary intake will be assessed by the interview administered Nutrition Data System for Research. | Up to 6 months |
| Physical activity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen Yeary | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D004035 | Diet Therapy |
| C407088 | Angptl4 protein, mouse |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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| Dietary Intervention | Other | Undergo CER intervention |
|
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| Dietary Intervention | Other | Undergo IF intervention |
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| Fasting | Behavioral | Undergo fasting |
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Will be assessed using the Paffenbarger Physical Activity Questionnaire (PAQ). The PAQ provides an estimate of calories expended per week in overall leisure time activity and in activities of light (5 kcal/min), medium (7.5 kcal/min) and high (19 kcal/min) intensity.
| Up to 6 months |
| Change from baseline in Prostate Cancer related biomarkers | Correlation of weight loss and PCa biomarkers. | Up to 6 months |
| Change in Urinary functions | urinary function changes will be tracked using a validated questionnaire, the International Prostate Symptom Score | Up to 6 months |
| Improvement of Quality of life | Self-reported outcomes routinely collected at each follow up clinic visit using validated questionnaire - UCLA PCI for quality of life.The UCLA PCI domain is scored on a scale of 0-100 points with higher values representing better outcomes. | Up to 6 months |
| Change in Sexual functions | Sexual health inventory for men (SHIM). The total score is obtained by adding all five item scores, and can range from 5 to 25. Higher scores indicate higher level of sexual function and less erectile dysfunction. | Up to 6 months |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |