- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03679260
Carbohydrate Restricted Diet Intervention for Men on Prostate Cancer Active Surveillance
March 28, 2023 updated by: Stephen Freedland, Cedars-Sinai Medical Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yunhee Choi-Kuaea, MSW
- Phone Number: 310-423-0333
- Email: Yunhee.Choi-Kuaea@cshs.org
Study Locations
-
-
California
-
Los Angeles, California, United States, 90048
- Cedars-Sinai Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
20 grams total carbs/day
Subject follows normal diet
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
|
20 grams total carbs/day
Subject follows normal diet
Weekly calls with dietitian
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
6 months
|
|
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
|
6 months
|
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
|
6 months
|
|
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
|
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.
Time Frame: 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.
Time Frame: 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 FACIT-F.
Time Frame: 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 IIEF-5.
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Stephen Freedland, MD, Cedars-Sinai Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 25, 2018
Primary Completion (Actual)
March 24, 2023
Study Completion (Actual)
March 24, 2023
Study Registration Dates
First Submitted
September 11, 2018
First Submitted That Met QC Criteria
September 18, 2018
First Posted (Actual)
September 20, 2018
Study Record Updates
Last Update Posted (Actual)
March 30, 2023
Last Update Submitted That Met QC Criteria
March 28, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIT2018-06-FREEDLAND-AS3
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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