Clinical Trial Detail

Clinical Trials

Clinical Trial Detail

Diet and Exercise Program in Promoting Weight Loss and Improving Health in Patients With Low- or Low-Intermediate-Risk Prostate Cancer (PALS)

Complete title: PALS: Prostate Cancer Active Lifestyle Study

Research Study Number 9369
 
Principal Investigator Jonathan Wright
 
Phase NA

Research Study Description

This randomized phase III trial studies a diet and exercise program based on the Diabetes Prevention Program in promoting weight loss and improving health compared to active surveillance in patients with low-risk or low-intermediate-risk prostate cancer. 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.

Eligibility Criteria (must meet the following to participate in this study)

Ages Eligible for Study: 40 Years and older (Adult, Senior)

Sexes Eligible for Study: Male

- 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

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

- 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

Other exclusion criteria may apply.

Research Study Number 9369
 
Contact Seattle Cancer Care Alliance Intake Office
 
Telephone 800-804-8824 / 206-606-1024
 

Keywords: Prostate Cancer; Solid Tumors; Neoplasms; Urogenital Neoplasms; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Genital Neoplasms, Male

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Please remember:

  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.

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