Clinical trial · Interventional
Effect of Weight Loss on Prostate Cancer Pathology
NCT00475982CI-TRIAL-00036842completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine if weight loss prior to radical prostatectomy effects chemical substances in the blood stream and prostate tissue that may affect prostate cancer development and progression.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Obesity | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No Weight Loss Group | Other | — | UNRESOLVED |
| Weight Loss | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1: Weight Loss
- description
- Weight Loss Group
- interventionNames
- Behavioral: Weight Loss
- type
- ACTIVE_COMPARATOR
- label
- Arm 2: No Weight Loss
- description
- No Weight Loss Group
- interventionNames
- Other: No Weight Loss Group
Primary outcomes (1)
- measure
- Apoptotic Index of the Highest Gleason Grade Malignant Epithelium in the Radical Prostatectomy Specimen Obtained After 8-weeks of the Dietary Intervention
- timeFrame
- 8 weeks
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: * Subject is overweight or obese (BMI \> 25 kg/m2) * Patient with pathologically confirmed adenocarcinoma of the prostate and has elected to undergo radical prostatectomy * Willing to delay radical prostatectomy for 5 to 8-weeks if randomized to the weight loss intervention group. * Able to adhere to physical activity intervention (able to walk for 30 minutes without rest) * Able to come to the VA for weight loss visits during the 5 to 8-wk study Exclusion Criteria: * Any one of the following: Gleason grade \> 4+4, PSA \> 20. * History of ever receiving androgen deprivation therapy, antiandrogen therapy, or finasteride * Prior prostate radiotherapy (external beam or brachytherapy) or prior cryotherapy * Diagnosis of diabetes mellitus and on insulin\*\* * Current use of weight loss medications or enrolled in a diet/weight loss program * Current use of lycopene supplements\*\*\* Significant co-morbidities (i.e. cardiac, pulmonary, liver disease, ongoing alcohol/drug abuse) Cardiac pacemaker
References
Publications (0)
Data not yet available
No reference posted for this study.