Carbohydrate Restricted Diet Intervention for Men on Prostate Cancer Active Surveillance
| Status: | Recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/8/2018 |
| Start Date: | December 2018 |
| End Date: | March 2023 |
| Contact: | Dana Levin, MPH |
| Email: | Dana.Levin@cshs.org |
| Phone: | 310-423-0333 |
Carbohydrate and Prostate Study 3: Carbohydrate Restricted Diet Intervention for Men on Prostate Cancer Active Surveillance
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.
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.
Inclusion Criteria:
- Pathologically confirmed prostate adenocarcinoma
- Most recent biopsy positive for prostate cancer (Most recent biopsy tissue available
for analysis)
- Currently on or starting active surveillance
- Ability to read, write, and understand English
- BMI >25 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
We found this trial at
1
site
8700 Beverly Blvd # 8211
Los Angeles, California 90048
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Stephen Freedland, MD
Phone: 310-423-0333
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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