Clinical trial · Interventional
Carbohydrate Restricted Diet Intervention for Men on Prostate Cancer Active Surveillance
Carbohydrate and Prostate Study 3: Carbohydrate Restricted Diet Intervention for Men on Prostate Cancer Active Surveillance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carbohydrate restricted diet | Other | — | UNRESOLVED |
| Non-restricted diet | Other | — | UNRESOLVED |
| Phone counseling with dietitian | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- Carbohydrate restricted diet and phone counseling with dietitian. After 6 months, patients will crossover to a non-restricted diet.
- interventionNames
- Other: Carbohydrate restricted diet
- Other: Non-restricted diet
- Other: Phone counseling with dietitian
- type
- EXPERIMENTAL
- label
- Arm B
- description
- Non-restricted diet and after 6 months, patients will crossover to a carbohydrate restricted diet and phone counseling with dietitian
- interventionNames
- Other: Carbohydrate restricted diet
- Other: Non-restricted diet
- Other: Phone counseling with dietitian
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available