Clinical trial · Interventional
Carbohydrate Restriction and Prostate Cancer Growth
A Randomized Controlled Clinical Trial of Carbohydrate Restriction Among Men With A Rising PSA After Failed Primary Therapy for Prostate Cancer
- 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)
No treatments have been shown to slow prostate cancer progression after radical prostatectomy. We hypothesize that a carbohydrate restricted diet will slow prostate cancer growth. A total of 60 men with a rising prostate-specific antigen (PSA) after failed primary treatment will be recruited and randomized to either a low-carbohydrate diet (\<20 grams carbohydrates/day) or a no-diet control (standard of care) for 6 months. The primary outcome is PSA doubling time.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Low carbohydrate diet | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Low carbohydrate, lifestyle counseling
- description
- The Low carbohydrate arm will receive counseling to follow a carbohydrate restriction diet (\<20 grams per day) for 6 months.
- interventionNames
- Behavioral: Low carbohydrate diet
- type
- NO_INTERVENTION
- label
- Control
- description
- The control arm will receive no dietary intervention.
Primary outcomes (1)
- measure
- PSA doubling time (change in PSA over time)
- timeFrame
- Baseline, 3 and 6 months
- description
- PSA doubling time will be estimated from PSA measured at baseline, 3 and 6 months post randomization.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Received prior radical prostatectomy or definitive local radiation for prostate cancer (either external beam radiation, brachytherapy, or combination) * PSA within the past 3 months is between 0.4 and 20 if prior radical prostatectomy, or between 3 and 20 ng/ml if prior radiation therapy. * PSA doubling time (PSADT) \>3 months and \<36 months 1. Calculated based at least 2 values (at least 0.2) in the prior 2 years with the first and last PSA separated by at least 3 months 2. Use all values in the last 2 years to calculate PSADT 3. PSADT calculated while NOT on androgen deprivation therapy (ADT). 4. If prior ADT use, then documented either A) normal testosterone or B) a testosterone within 50 points of normal and stable (defined as a second testosterone at least 6 weeks later that is equal or lower than the first testosterone) is required before starting to calculate PSADT. * BMI \>=24 kg/m2 * Willing to be randomized to a no-diet control or a low-carbohydrate diet * Reads, writes, and understands English Exclusion Criteria: * Anticipate needing secondary prostate cancer therapy within the next 6 months (i.e. radiation, or hormonal therapy) * Current use of weight loss medications including herbal weight loss supplements or enrolled in a diet/weight loss program * Currently on therapy aimed at lowering testosterone levels (includes gonadotropin-releasing hormone (GnRH) agonist/antagonist, prior bilateral orchiectomy, oral anti-androgens, or 5-alpha reductase inhibitors). Testosterone replacement is allowed but treatment should be stable during the entire study. * Known distant metastatic disease * Already consuming a carbohydrate-restricted or vegetarian diet * Unable or unwilling to adhere to a carbohydrate-restricted dietary intervention * Weight loss \>5% of body weight in the last 6 months * Medical comorbidities that in the opinion of the investigator limits the patient's ability to complete this study
References
Publications (3)
- DERIVEDLin PH, Howard L, Freedland SJ. Weight loss via a low-carbohydrate diet improved the intestinal permeability marker, zonulin, in prostate cancer patients. Ann Med. 2022 Dec;54(1):1221-1225. doi: 10.1080/07853890.2022.2069853. PMID 35486445
- DERIVEDLin PH, Howard L, Freedland SJ. Impact of Low Carbohydrate Diet on Self-Report Fatigue and Weakness in Prostate Cancer Patients. J Urol. 2021 Sep;206(3):499-501. doi: 10.1097/JU.0000000000001780. Epub 2021 Apr 5. No abstract available. PMID 33819069
- DERIVEDFreedland SJ, Allen J, Jarman A, Oyekunle T, Armstrong AJ, Moul JW, Sandler HM, Posadas E, Levin D, Wiggins E, Howard LE, Wu Y, Lin PH. A Randomized Controlled Trial of a 6-Month Low-Carbohydrate Intervention on Disease Progression in Men with Recurrent Prostate Cancer: Carbohydrate and Prostate Study 2 (CAPS2). Clin Cancer Res. 2020 Jun 15;26(12):3035-3043. doi: 10.1158/1078-0432.CCR-19-3873. Epub 2020 Feb 27. PMID 32108029