Prostate Cancer
Conditions
Keywords
Prostate Cancer, Prostate Adenocarcinoma, Active Surveillance, Diet, Weight Loss, low carb, Ketogenic Diet, Ketogenic
Brief summary
This phase 2 waitlist-controlled, randomized trial is designed to compare the difference in proliferative index (Ki67) between carbohydrate restricted diet and usual care over a 6 month period in men with prostate cancer who have been placed on Active Surveillance. Eligible patients include men over 18 years old, BMI \>25, with their most recently performed biopsy pathologically confirming prostate adenocarcinoma who have been placed on AS. Arms of the trial will be randomized 1:1 in a crossover approach, with Arm A receiving a carb restricted diet over 6 months then SOC and Arm B receiving the waitlist control arm (i.e. SOC then allowed to go on diet after 6 months). Ki67 will be performed on tissue from the most recent biopsy at the beginning of the study and again on tissue obtained in the 6 month SOC biopsy. Every patient will be on the study for 12 months, and the study will continue for approximately 3.5 years.
Interventions
20 grams total carbs/day
OTHERNon-restricted diet
Subject follows normal diet
Weekly calls with dietitian
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pathologically confirmed prostate adenocarcinoma * Most recent biopsy positive for prostate cancer * Currently on or starting active surveillance * Ability to read, write, and understand English * BMI \>24 kg/m2 * Written informed consent obtained from subject and ability for subject to comply with the requirements of the study. * Scheduled to undergo a prostate biopsy in 6 months as part of standard of care for their prostate cancer * Age \> 18 years
Exclusion criteria
* Already consuming a severely carbohydrate-restricted (i.e. \<20g total carbohydrates per day) or vegetarian diet * Medical comorbidities that in the opinion of the investigator limits the patient's ability to complete this study * Anticipate needing prostate cancer therapy within the next 12 months (i.e. surgery, radiation, or hormonal therapy) * Loss of \>10% of body weight within the previous 6 months * Currently receiving any oral hormonal therapy for prostate cancer or BPH (finasteride, dutasteride, bicalutamide) * If prior oral hormonal therapy use for prostate cancer or BPH (as defined above), must not have been taking at time of prior biopsy and must be off for at least 3 months prior to study enrollment (oral medications) * Having ever received any injection hormonal therapy or investigational vaccine for prostate cancer (LHRH agonist, LHRH antagonists, ProstVax, Provenge) * Current use of weight loss medications including herbal weight loss supplements or enrolled in a diet/weight loss program
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean difference change in proliferative index in prostate cancer patients between carbohydrate restricted diet and non-restricted diet groups from pre-study biopsy (baseline) to 6 months. | 6 months | Proliferative index is measured by Ki67/apoptosis rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean difference in absolute risk of progression to AUA intermediate risk from baseline to 6 months. | 6 months | AUA intermediate risk is PSA \> 10ng/ml or grade group ≥ 2 or clinical stage ≥ T2b |
| Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using EORTC-QLQ-C30. | 6 months | — |
| Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using IPSS. | 6 months | — |
| Mean difference in weight loss before and after intervention between between carbohydrate restricted diet and non-restricted diet groups from baseline to 6 months. | 6 months | — |
| Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using PROMIS-fatigue. | 6 months | — |
| Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using FACIT-F. | 6 months | — |
| Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using IIEF-5. | 6 months | — |
| Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using FACT-Cog. | 6 months | — |
Countries
United States
Outcome results
None listed