NCT03679260

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_2 prostate-cancer

Timeline
Completed

Started Sep 2018

Typical duration for phase_2 prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 20, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

September 25, 2018

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2023

Completed
Last Updated

March 30, 2023

Status Verified

March 1, 2023

Enrollment Period

4.5 years

First QC Date

September 11, 2018

Last Update Submit

March 28, 2023

Conditions

Prostate Cancer

Keywords

Prostate CancerProstate AdenocarcinomaActive SurveillanceDietWeight Losslow carbKetogenic DietKetogenic

Outcome Measures

Primary Outcomes (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.

    Proliferative index is measured by Ki67/apoptosis rate

    6 months

Secondary Outcomes (8)

  • 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

  • Mean difference in absolute risk of progression to AUA intermediate risk from baseline to 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 EORTC-QLQ-C30.

    6 months

  • Mean difference in quality of life between carbohydrate restricted diet and non-restricted diet from baseline to 6 months; measured using IPSS.

    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.

    6 months

  • +3 more secondary outcomes

Study Arms (2)

Arm A

EXPERIMENTAL

Carbohydrate restricted diet and phone counseling with dietitian. After 6 months, patients will crossover to a non-restricted diet.

Other: Carbohydrate restricted dietOther: Non-restricted dietOther: Phone counseling with dietitian

Arm B

EXPERIMENTAL

Non-restricted diet and after 6 months, patients will crossover to a carbohydrate restricted diet and phone counseling with dietitian

Other: Carbohydrate restricted dietOther: Non-restricted dietOther: Phone counseling with dietitian

Interventions

Carbohydrate restricted dietOTHER

20 grams total carbs/day

Arm AArm B
Non-restricted dietOTHER

Subject follows normal diet

Arm AArm B
Phone counseling with dietitianOTHER

Weekly calls with dietitian

Arm AArm B

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Prostatic NeoplasmsWeight Loss

Interventions

Diet, Carbohydrate-RestrictedNutritionists

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth PersonnelHealth Care Facilities Workforce and Services

Study Officials

  • Stephen Freedland, MD

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Center for Integrated Research in Cancer and Lifestyle; Co-Director, Cancer Genetics and Prevention Program; Professor, Surgery

Study Record Dates

First Submitted

September 11, 2018

First Posted

September 20, 2018

Study Start

September 25, 2018

Primary Completion

March 24, 2023

Study Completion

March 24, 2023

Last Updated

March 30, 2023

Record last verified: 2023-03

Locations

US(1)