Carbohydrate Restriction and Prostate Cancer Growth

NCT01763944 | Completed

• 3 other identifiers: Pro000418571K24CA160653-01A1192822
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 3

Brief Summary

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

Prostate Cancer

Keywords

diet; prostate cancer; carbohydrate; lifestyle

Outcome Measures

Primary Outcomes (1)

• PSA doubling time (change in PSA over time)

  PSA doubling time will be estimated from PSA measured at baseline, 3 and 6 months post randomization.

  Baseline, 3 and 6 months

Study Arms (2)

Low carbohydrate, lifestyle counseling

ACTIVE COMPARATOR

The Low carbohydrate arm will receive counseling to follow a carbohydrate restriction diet (\<20 grams per day) for 6 months.

Behavioral: Low carbohydrate diet

Control

NO INTERVENTION

The control arm will receive no dietary intervention.

Interventions

Low carbohydrate diet BEHAVIORAL

The Low carbohydrate diet intervention recommends patients to limit carbohydrate intake to less than 20 gram per day.

Low carbohydrate, lifestyle counseling

Eligibility Criteria

• Age: 20 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• Use all values in the last 2 years to calculate PSADT
• PSADT calculated while NOT on androgen deprivation therapy (ADT).
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator
• Robert C. Atkins Foundation: collaborator
• Cedars-Sinai Medical Center: collaborator
• Durham VA Medical Center: collaborator

Study Sites (3)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Duke University Medical Center

Durham, North Carolina, 27702, United States

Location

Durham VA Medical Center

Durham, North Carolina, 27705, United States

Location

Related Publications (3)

• Lin 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 DERIVED

• Lin 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 DERIVED

• Freedland 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 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Diet, Carbohydrate-Restricted

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Pao-Hwa Lin

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2012
• First Posted: January 9, 2013
• Study Start: December 16, 2013
• Primary Completion: August 20, 2018
• Study Completion: August 20, 2018
• Last Updated: October 12, 2018

Record last verified: 2018-10

Locations

US (3)