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Does Protein Restriction Inhibit Prostrate Cancer Growth

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ClinicalTrials.gov Identifier: NCT01692587
Recruitment Status : Completed
First Posted : September 25, 2012
Last Update Posted : October 17, 2016
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:

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 or disease Intervention/treatment Phase
Prostate Cancer Other: Protein restrictive diet Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Does Protein Restriction Inhibit Prostrate Cancer Growth
Study Start Date : January 2011
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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) ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01692587     History of Changes
Other Study ID Numbers: 201011804
First Posted: September 25, 2012    Key Record Dates
Last Update Posted: October 17, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Plan to publish

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