Does Protein Restriction Inhibit Prostrate Cancer Growth
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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 |
- 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: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (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 |
Inclusion Criteria:
group 1
- Patient must have a diagnosis of prostate cancer confirmed by pathology.
- 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).
- Patient must have adequate baseline protein intake (screening 4-day food record shows protein > 1.0 g/kg FFM)
- Patient must be able to understand the English-language instructions.
- Patient must be able to comply with the low protein diet (as evaluated by the dietitian and other study team members).
- Patient must be able to understand and willing to sign an IRB-approved written informed consent document.
5.2.2 Inclusion Criteria - Group 2
- Patient must have a diagnosis of prostate cancer.
- Patient must have previously undergone a radical prostatectomy for treatment of prostate cancer.
- 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).
- Patient must have adequate baseline protein intake (screening 4-day food record shows protein > 1.0 g/kg FFM).
- Patient must have adequate baseline caloric intake (screening 4-day food record shows caloric intake of > 1500 kcal/day).
- Patient must be able to understand the English-language instructions.
- Patient must be able to comply with the low protein diet (as evaluated by the dietitian and other study team members).
- Patient must be able to understand and willing to sign an IRB-approved written informed consent document.
Exclusion Criteria:
- Patient must not currently be receiving any therapy for prostate cancer.
- Patient must not have any serious chronic illness such as unstable angina, any uncontrolled metabolic disorder, or any immunologic disorder.
- 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).
- Patient must not have a previous history of a stroke.
- 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).
- Patient must not have dementia or any other cognitive impairment.
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| United States, Missouri | |
| Washington University School of Medicine | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Contact: Shohreh Jamalabadi-Majidi, DMD,MPH 314-362-2399 sjamalab@dom.wustl.edu | |
| Principal Investigator: Luigi Fontana, MD, PhD | |
| 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 20, 2012 |
| 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 May 16, 2013