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Carbohydrate Restricted Diet Intervention for Men on Prostate Cancer Active Surveillance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03679260
Recruitment Status : Recruiting
First Posted : September 20, 2018
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Stephen Freedland, Cedars-Sinai Medical Center

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 Intervention/treatment Phase
Prostate Cancer Other: Carbohydrate restricted diet Other: Non-restricted diet Other: Phone counseling with dietitian Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Carbohydrate and Prostate Study 3: Carbohydrate Restricted Diet Intervention for Men on Prostate Cancer Active Surveillance
Actual Study Start Date : September 25, 2018
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Arm A
Carbohydrate restricted diet and phone counseling with dietitian. After 6 months, patients will crossover to a non-restricted diet.
Other: Carbohydrate restricted diet
20 grams total carbs/day

Other: Non-restricted diet
Subject follows normal diet

Other: Phone counseling with dietitian
Weekly calls with dietitian

Experimental: Arm B
Non-restricted diet and after 6 months, patients will crossover to a carbohydrate restricted diet and phone counseling with dietitian
Other: Carbohydrate restricted diet
20 grams total carbs/day

Other: Non-restricted diet
Subject follows normal diet

Other: Phone counseling with dietitian
Weekly calls with dietitian




Primary Outcome Measures :
  1. 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. [ Time Frame: 6 months ]
    Proliferative index is measured by Ki67/apoptosis rate


Secondary Outcome Measures :
  1. Mean difference in weight loss before and after intervention between between carbohydrate restricted diet and non-restricted diet groups from baseline to 6 months. [ Time Frame: 6 months ]
  2. Mean difference in absolute risk of progression to AUA intermediate risk from baseline to 6 months. [ Time Frame: 6 months ]
    AUA intermediate risk is PSA > 10ng/ml or grade group ≥ 2 or clinical stage ≥ T2b

  3. Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using EORTC-QLQ-C30. [ Time Frame: 6 months ]
  4. Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using IPSS. [ Time Frame: 6 months ]
  5. Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using FACT-Cog. [ Time Frame: 6 months ]
  6. Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using PROMIS-fatigue. [ Time Frame: 6 months ]
  7. Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using FACIT-F. [ Time Frame: 6 months ]
  8. Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using IIEF-5. [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03679260


Contacts
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Contact: Dana Levin, MPH 310-423-0333 Dana.Levin@cshs.org
Contact: Laura Lockshon 424-315-2219 Laura.Lockshon@cshs.org

Locations
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United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Dana Levin, MPH    310-423-0333    Dana.Levin@cshs.org   
Principal Investigator: Stephen Freedland, MD         
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
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Principal Investigator: Stephen Freedland, MD Cedars-Sinai Medical Center

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Responsible Party: Stephen Freedland, Director, Center for Integrated Research in Cancer and Lifestyle; Co-Director, Cancer Genetics and Prevention Program; Professor, Surgery, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT03679260    
Other Study ID Numbers: IIT2018-06-FREEDLAND-AS3
First Posted: September 20, 2018    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stephen Freedland, Cedars-Sinai Medical Center:
Prostate Cancer
Prostate Adenocarcinoma
Active Surveillance
Diet
Weight Loss
low carb
Ketogenic Diet
Ketogenic
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases