Carbohydrate Restricted Diet Intervention for Men on Prostate Cancer Active Surveillance

Prostate Cancer Clinical Trial

Official title:

Carbohydrate and Prostate Study 3: Carbohydrate Restricted Diet Intervention for Men on Prostate Cancer Active Surveillance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03679260
• Other study ID #: IIT2018-06-FREEDLAND-AS3
• Status: Completed
• Phase: Phase 2
• Start date: September 25, 2018
• Est. completion date: March 24, 2023

Study information

• Verified date: March 2023
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 24, 2023
• Est. primary completion date: March 24, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• Carbohydrate restricted diet
20 grams total carbs/day
• Non-restricted diet
Subject follows normal diet
• Phone counseling with dietitian
Weekly calls with dietitian

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Proliferative index is measured by Ki67/apoptosis rate	6 months
Secondary	Mean difference in weight loss before and after intervention between between carbohydrate restricted diet and non-restricted diet groups from baseline to 6 months.		6 months
Secondary	Mean difference in absolute risk of progression to AUA intermediate risk from baseline to 6 months.	AUA intermediate risk is PSA > 10ng/ml or grade group = 2 or clinical stage = T2b	6 months
Secondary	Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using EORTC-QLQ-C30.		6 months
Secondary	Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using IPSS.		6 months
Secondary	Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using FACT-Cog.		6 months
Secondary	Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using PROMIS-fatigue.		6 months
Secondary	Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using FACIT-F.		6 months
Secondary	Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using IIEF-5.		6 months