Carbohydrate-Restricted Diet in Treating Patients with Previously Treated Prostate Cancer

Status: Active

Description

This randomized phase II trial studies how well carbohydrate-restricted diet works in treating patients with previously treated prostate cancer. A low-carbohydrate diet may prevent or slow disease progression in patients with prostate cancer who failed to respond to prior therapy.

Eligibility Criteria

Inclusion Criteria

  • Received prior radical prostatectomy (with or without post-operative radiation) or definitive local radiation for prostate cancer (either external beam radiation, brachytherapy, or combination)
  • PSA within the past 2 months is between 3 and 20 ng/ml if patient received local radiation OR between 0.4 and 20 ng/ml if patient received prior radical prostatectomy
  • PSADT > 3 months and < 36 months * Calculated based at least 2 values that are post-treatment and > 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 that are post-treatment and > 0.2 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
  • Body mass index (BMI) >= 24 kg/m^2
  • Willing to be randomized to a no dietary intervention control group or to a low-carbohydrate diet group
  • 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 based on self-report
  • Medical comorbidities that in the opinion of the investigator limits the patient’s ability to complete this study

Locations & Contacts

California

Los Angeles
Cedars Sinai Medical Center
Status: Active
Contact: Stephen Jay Freedland
Email: Stephen.Freedland@cshs.org
Veterans Administration Los Angeles Healthcare System
Status: Active
Contact: William Aronson
Phone: 310-478-3711
Email: waronson@g.ucla.edu

North Carolina

Durham
Duke University Medical Center
Status: Active
Contact: Pao-Hwa Lin
Phone: 919-660-6685
Email: pao.hwa.lin@dm.duke.edu
Durham VA Medical Center
Status: Active
Contact: Stephen Jay Freedland
Email: Stephen.Freedland@cshs.org

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. Examine the effects of carbohydrate restriction on prostate specific antigen doubling time (PSADT) relative to a no-dietary intervention control among men with prostate specific antigen (PSA) recurrence after definitive therapy for prostate cancer.

II. Examine the effects of carbohydrate restriction on weight loss.

III. Examine the effects of carbohydrate restriction on markers of energy metabolism including resting metabolic rate.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive a carbohydrate-restricted diet (less than 20 grams carbohydrate/day) for 6 months.

ARM II: Patients receive no diet control for 6 months. After 6 months, patients are offered the same carbohydrate-restricted diet as in Arm I, if interested.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
Duke University Medical Center

Principal Investigator
Pao-Hwa Lin

Trial IDs

Primary ID Pro00041857
Secondary IDs NCI-2013-00581, 00041857
Clinicaltrials.gov ID NCT01763944