TerminatedNot Applicable

Diet and Exercise Program to Promote Weight Loss and Improve Health in Men With Low- or Low-Intermediate-Risk Prostate Cancer

Stopped: Terminated due to insufficient funding

United States117 participantsStarted 2016-05-19

Plain-language 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.

Who can participate

Age range

40 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change From Baseline in Fasting Glucose at 6 Months

Timeframe: Baseline to 6 months

Change From Baseline in Fasting C-peptide, IGF-1, IGF-BP3, and Adiponectin at 6 Months

Timeframe: Baseline to 6 months

Change in Expression of Insulin Receptor (IR), IGF-1R, and Protein Kinase B (AKT) on Prostate Cancer Epithelial Cells

Timeframe: Baseline (6 months prior to randomization) to follow-up surveillance biopsy (6 months post-randomization)

Weight at 12 Months

Timeframe: 12 months (6 months after active intervention)

Change From Baseline in Fasting Insulin at 6 Months

Timeframe: Baseline to 6 months

Trial details

NCT IDNCT02454517

SponsorFred Hutchinson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-09-30

Results submitted2022-09-28

View on ClinicalTrials.gov More Prostate Adenocarcinoma trials

Plain-language summary

Who can participate

Age range

40 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change From Baseline in Fasting Glucose at 6 Months

Timeframe: Baseline to 6 months

Change From Baseline in Fasting C-peptide, IGF-1, IGF-BP3, and Adiponectin at 6 Months

Timeframe: Baseline to 6 months

Change in Expression of Insulin Receptor (IR), IGF-1R, and Protein Kinase B (AKT) on Prostate Cancer Epithelial Cells

Timeframe: Baseline (6 months prior to randomization) to follow-up surveillance biopsy (6 months post-randomization)

Weight at 12 Months

Timeframe: 12 months (6 months after active intervention)

Change From Baseline in Fasting Insulin at 6 Months

Timeframe: Baseline to 6 months