Clinical trial · Interventional
Diet and Exercise Program to Promote Weight Loss and Improve Health in Men With Low- or Low-Intermediate-Risk Prostate Cancer
PALS: Prostate Cancer Active Lifestyle Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Terminated due to insufficient funding
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Stage IIA Prostate Cancer AJCC v7 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Prostate Cancer AJCC V7 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Behavioral Dietary Intervention | Behavioral | — | UNRESOLVED |
| Exercise Intervention | Behavioral | — | UNRESOLVED |
| Informational Intervention | Other | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (diet and exercise lifestyle intervention)
- description
- 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.
- interventionNames
- Behavioral: Behavioral Dietary Intervention
- Behavioral: Exercise Intervention
- Other: Laboratory Biomarker Analysis
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- type
- ACTIVE_COMPARATOR
- label
- Arm II (control)
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available