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A Randomized Controlled Clinical Trial of Carbohydrate Restriction Among Men With A Rising PSA After Failed Primary Therapy for Prostate Cancer


Phase 2
20 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

A Randomized Controlled Clinical Trial of Carbohydrate Restriction Among Men With A Rising PSA After Failed Primary Therapy for Prostate Cancer


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 3 and 10 ng/ml

- PSA doubling time (PSADT) >3 months and <24 months

1. Calculated based at least 2 values 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 hormonal therapy

4. If prior hormonal therapy use, then documented normal testosterone is required
before starting to calculate PSADT

- BMI >25 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 altering testosterone levels (includes
gonadotropin-releasing hormone (GnRH) agonist/antagonist, prior bilateral
orchiectomy, oral anti-androgens, or 5-alpha reductase inhibitors)

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

PSA doubling time (change in PSA over time)

Outcome Description:

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

Outcome Time Frame:

Baseline, 3 and 6 months

Safety Issue:

No

Principal Investigator

Pao-Hwa Lin

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University

Authority:

United States: Institutional Review Board

Study ID:

Pro00041857

NCT ID:

NCT01763944

Start Date:

January 2013

Completion Date:

December 2016

Related Keywords:

  • Prostate Cancer
  • diet
  • prostate cancer
  • carbohydrate
  • lifestyle
  • Prostatic Neoplasms

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