Does Protein Restriction Inhibit Prostrate Cancer Growth

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01692587
First received: September 7, 2012
Last updated: September 11, 2014
Last verified: September 2014
  Purpose

The Purpose of the Protein Study is to investigate whether a reduced protein diet can inhibit the growth of prostate cancer in humans.

The Investigators hypothesis is that a reduced protein diet will inhibit expression of genes that are involved in the growth of prostate cancer.


Condition Intervention
Prostate Cancer
Other: Protein restrictive diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Does Protein Restriction Inhibit Prostrate Cancer Growth

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Group1--Expression of genes and proteins of the PI-3K/Akt/mTOR pathway. Group 2--PSA values obtained every three months [ Time Frame: group 1- (4-6 weeks), group 2 -(52 weeks) ] [ Designated as safety issue: No ]
    The investigators will be looking at the increase or decrease of PSA values between control and protein restricted diet participants obtained for the length of study.


Estimated Enrollment: 82
Study Start Date: January 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
No changes in dietary group
Experimental: Protein restrictive diet
reduced protein diet
Other: Protein restrictive diet
To begin a reduced protein diet

Detailed Description:

The primary objective of this study is to determine whether or not a low protein diet has an inhibitory effect on prostate cancer cell growth.

The primary outcome measures relative to the investigators primary objectives are:

For Group 1 the expression of genes and proteins of the PI-3K/Akt/mTOR pathway. For Group 2 the PSA values obtained every three months.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

group 1

  1. Patient must have a diagnosis of prostate cancer confirmed by pathology.
  2. Patient must be scheduled to undergo radical prostatectomy no sooner than 6 weeks from date of enrollment (to allow for a minimum of 4 weeks on the low protein diet).
  3. Patient must have adequate baseline protein intake (screening 4-day food record shows protein > 1.0 g/kg FFM)
  4. Patient must be able to understand the English-language instructions.
  5. Patient must be able to comply with the low protein diet (as evaluated by the dietitian and other study team members).
  6. Patient must be able to understand and willing to sign an IRB-approved written informed consent document.

5.2.2 Inclusion Criteria - Group 2

  1. Patient must have a diagnosis of prostate cancer.
  2. Patient must have previously undergone a radical prostatectomy for treatment of prostate cancer.
  3. Patient must have a detectable PSA (defined as PSA ≥ 0.1) in at least two consecutive measurements, taken at least one month apart, with no therapy between the PSA measurements. If the patient has had additional therapy after the radical prostatectomy, there must be evidence of a rising PSA (i.e., two consecutive measurements at least one month apart) after the patient has completed the intervening therapy (meaning that the patient must have failed treatment).
  4. Patient must have adequate baseline protein intake (screening 4-day food record shows protein > 1.0 g/kg FFM).
  5. Patient must have adequate baseline caloric intake (screening 4-day food record shows caloric intake of > 1500 kcal/day).
  6. Patient must be able to understand the English-language instructions.
  7. Patient must be able to comply with the low protein diet (as evaluated by the dietitian and other study team members).
  8. Patient must be able to understand and willing to sign an IRB-approved written informed consent document.

Exclusion Criteria:

  1. Patient must not currently be receiving any therapy for prostate cancer.
  2. Patient must not have any serious chronic illness such as unstable angina, any uncontrolled metabolic disorder, or any immunologic disorder.
  3. Patient must not have a history of any previous malignancy (with the exception of squamous or basal cell carcinoma of the skin) in the 5 years prior to enrollment (for Group 1) or 12 months prior to enrollment (for Group 2).
  4. Patient must not have a previous history of a stroke.
  5. Patient must not be taking any medications that might confound the study results (anabolic agents (such as androgen, androgen precursor, rhGH) in the 6 months prior to enrollment; corticosteroids (other than nasal) in the 6 months prior to enrollment; or finasteride or dutasteride).
  6. Patient must not have dementia or any other cognitive impairment.
  7. Patient must not have a lifestyle or fixed diet pattern that would interfere with participation in or interpretation of the results of this study

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01692587

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Luigi Fontana, MD,PhD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01692587     History of Changes
Other Study ID Numbers: 201011804
Study First Received: September 7, 2012
Last Updated: September 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
PSA
protein
prostate

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on October 19, 2014