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NCT03679260 | COMPLETED | Prostate Cancer

Carbohydrate Restricted Diet Intervention for Men on Prostate Cancer Active Surveillance
Sponsor:

Cedars-Sinai Medical Center

Information provided by (Responsible Party):

Stephen Freedland

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.

Condition or disease

Prostate Cancer

Intervention/treatment

Carbohydrate restricted diet

Non-restricted diet

Phone counseling with dietitian

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 22 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Carbohydrate and Prostate Study 3: Carbohydrate Restricted Diet Intervention for Men on Prostate Cancer Active Surveillance
Actual Study Start Date : 2018-09-25
Estimated Primary Completion Date : 2023-03-24
Estimated Study Completion Date : 2023-03-24

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers:
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
Carbohydrate Restricted Diet Intervention for Men on Prostate Cancer Active Surveillance

Location Details

NCT03679260

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, California

Cedars-Sinai Medical Center

Los Angeles, California, United States, 90048