Clinical trial NCT03679260: Carbohydrate Restricted Diet Intervention for Men on Prostate Cancer Active Surveillance
Official title: Carbohydrate and Prostate Study 3: Carbohydrate Restricted Diet Intervention for Men on Prostate Cancer Active Surveillance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Prostate Adenocarcinoma
Active Surveillance
Diet
Weight Loss
low carb
Ketogenic Diet
Ketogenic
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2018-09-20
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 6 months
Secondary outcomes:
measure: Mean difference in weight loss before and after intervention between between carbohydrate restricted diet and non-restricted diet groups from baseline to 6 months.
timeFrame: 6 months
measure: Mean difference in absolute risk of progression to AUA intermediate risk from baseline to 6 months.
timeFrame: 6 months
measure: Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using EORTC-QLQ-C30.
timeFrame: 6 months
measure: Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using IPSS.
timeFrame: 6 months
measure: Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using FACT-Cog.
timeFrame: 6 months
measure: Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using PROMIS-fatigue.
timeFrame: 6 months
measure: Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using FACIT-F.
timeFrame: 6 months
measure: Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using IIEF-5.
timeFrame: 6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Stephen Freedland, MD
role: PRINCIPAL_INVESTIGATOR
References: