Clinical trial · Interventional
Prostate Nutrition and Exercise STudy (ProNEST)
NCT03173807CI-TRIAL-00029817ProNESTwithdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Unable to find adequate funding
Summary
Brief summary (as posted)
The purpose of this study is to test the feasibility of nutrition and exercise counseling program for reducing the incidence of metabolic syndrome in prostate cancer patients on Androgen Deprivation Therapy.
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 |
|---|---|---|---|
| Diet Modification | — | UNRESOLVED | — |
| Metabolic Syndrome | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| diet and exercise guidance and modifications | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- dietary and exercise counseling
- description
- The duration of study in Arm A will be 24 months, with study assessments and interventions (review of diet, food diary, and guidance from the dietician; review of activity journal, assessment of body composition, tests for gait, balance and muscle strength, and new assignment from the exercise trainer) done at baseline, 3 months, 6 months, 12 months and 24 months.
- interventionNames
- Behavioral: diet and exercise guidance and modifications
- type
- ACTIVE_COMPARATOR
- label
- standard of care
- description
- The duration of study in Arm B will be 24 months, with study assessments and interventions (review of diet, food diary, and guidance from the dietician; review of activity journal, assessment of body composition, tests for gait, balance and muscle strength, and new assignment from the exercise trainer) done at baseline, 12 months, 15 months, 18 months and 24 months. At 12 months, participants in Arm B will be offered the same intervention that Arm A received during months 1-12.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient has provided written, informed consent 2. 18 years of age or greater 3. Histologically or biochemically confirmed hormone-naïve prostate adenocarcinoma 4. Recently started or re-started ADT within 4 months of starting the study 5. Eastern Oncology Co-operative Group (ECOG) performance 0-1 6. Patient who is on an antihypertensive medications with a blood pressure less than 130 systolic and 85 mm Hg diastolic 7. Patient who is on an antihyperlipidemic agents with TG ≤ 150 mg/dl, serum HDL ≥40 mg/dL Exclusion Criteria: 1. Current use of taxane based chemotherapy for metastatic disease 2. Clinically significant or active cardiovascular disease: 1. No previous MI within the past 12 months 2. No uncontrolled angina within 12 months 3. History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place 4. Uncontrolled hypertension (systolic BP \> 170 mmHg or diastolic BP \> 100 mmHg at screening) 5. CHF with NYHA class 3 or 4 3. Structurally unstable bone lesions suggesting impending fracture 4. Estimated life expectancy of \< 6 months 5. Patients who meet criteria for metabolic syndrome that are uncontrolled based on the Internal Diabetes Federation.
References
Publications (0)
Data not yet available
No reference posted for this study.