Clinical trial · Interventional
Atkins Diet and Prostate Cancer Clinical Trial
Randomized Controlled Clinical Trial of Carbohydrate Restriction Among Men Initiating Androgen Deprivation Therapy For Prostate Cancer
NCT00932672CI-TRIAL-00020086terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): slow recruitment, lack of funding and PI transferred
Summary
Brief summary (as posted)
This study will test the hypothesis that a low-carbohydrate Atkins diet will prevent or at least minimize the metabolic consequences of androgen deprivation therapy (ADT).
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 |
|---|---|---|---|
| Atkins Diet | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Atkins group
- description
- Men assigned to the Atkins diet will be asked to restrict carbohydrate intake to \<20 grams/day. We will use an established clinical program directed by Dr. Eric Westman which implements this diet using a trained clinical nutritionist. No other dietary restrictions will be placed on the subjects. They will measure their urinary ketones at home weekly using urinary ketone strips. Subjects will meet with the nutritionist monthly during the 6 months of the study. Subjects in the Atkins arm will also be asked to walk at a brisk pace for 30 minutes a day, 5 days a week and will be provided a pedometer to measure the number of steps taken per day.
- interventionNames
- Behavioral: Atkins Diet
- type
- NO_INTERVENTION
- label
- Control group
- description
- Subjects assigned to the control group will be asked to make no changes in their dietary habits. At the completion of the study subjects will meet with the nutritionist and receive standard nutrition AHA recommendations.
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed adenocarcinoma of the prostate 2. Scheduled to initiate ADT with an anticipated duration of ≥ 6 months 3. Overweight or obese (body mass index ≥ 25 kg/m2) Exclusion Criteria: 1. Symptomatic metastatic disease 2. Myocardial infarction within 6 months 3. Treatment with medications known to affect insulin or glucose levels (i.e. insulin, oral hypoglycemics, prednisone, etc.) 4. Patient consuming a low-carbohydrate diet 5. Medical conditions or co-morbidities that preclude participation in the protocol 6. Vegetarians
References
Publications (15)
- BACKGROUNDLoblaw DA, Virgo KS, Nam R, Somerfield MR, Ben-Josef E, Mendelson DS, Middleton R, Sharp SA, Smith TJ, Talcott J, Taplin M, Vogelzang NJ, Wade JL 3rd, Bennett CL, Scher HI; American Society of Clinical Oncology. Initial hormonal management of androgen-sensitive metastatic, recurrent, or progressive prostate cancer: 2006 update of an American Society of Clinical Oncology practice guideline. J Clin Oncol. 2007 Apr 20;25(12):1596-605. doi: 10.1200/JCO.2006.10.1949. Epub 2007 Apr 2. PMID 17404365
- BACKGROUNDBolla M, Gonzalez D, Warde P, Dubois JB, Mirimanoff RO, Storme G, Bernier J, Kuten A, Sternberg C, Gil T, Collette L, Pierart M. Improved survival in patients with locally advanced prostate cancer treated with radiotherapy and goserelin. N Engl J Med. 1997 Jul 31;337(5):295-300. doi: 10.1056/NEJM199707313370502. PMID 9233866
- BACKGROUNDSmith MR, Lee H, Nathan DM. Insulin sensitivity during combined androgen blockade for prostate cancer. J Clin Endocrinol Metab. 2006 Apr;91(4):1305-8. doi: 10.1210/jc.2005-2507. Epub 2006 Jan 24. PMID 16434464
- BACKGROUNDKeating NL, O'Malley AJ, Smith MR. Diabetes and cardiovascular disease during androgen deprivation therapy for prostate cancer. J Clin Oncol. 2006 Sep 20;24(27):4448-56. doi: 10.1200/JCO.2006.06.2497. PMID 16983113
- BACKGROUNDTsai HK, D'Amico AV, Sadetsky N, Chen MH, Carroll PR. Androgen deprivation therapy for localized prostate cancer and the risk of cardiovascular mortality. J Natl Cancer Inst. 2007 Oct 17;99(20):1516-24. doi: 10.1093/jnci/djm168. Epub 2007 Oct 9. PMID 17925537
- BACKGROUNDD'Amico AV, Chen MH, Renshaw AA, Loffredo M, Kantoff PW. Androgen suppression and radiation vs radiation alone for prostate cancer: a randomized trial. JAMA. 2008 Jan 23;299(3):289-95. doi: 10.1001/jama.299.3.289. PMID 18212313
- BACKGROUNDSaigal CS, Gore JL, Krupski TL, Hanley J, Schonlau M, Litwin MS; Urologic Diseases in America Project. Androgen deprivation therapy increases cardiovascular morbidity in men with prostate cancer. Cancer. 2007 Oct 1;110(7):1493-500. doi: 10.1002/cncr.22933.