Does Protein Restriction Inhibit Prostrate Cancer Growth

NCT01692587 | Completed DMC

• 1 other identifier: 201011804
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

PSA; protein; prostate

Outcome Measures

Primary Outcomes (1)

• Group1--Expression of genes and proteins of the PI-3K/Akt/mTOR pathway. Group 2--PSA values obtained every three months

  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.

  group 1- (4-6 weeks), group 2 -(52 weeks)

Study Arms (2)

Control

NO INTERVENTION

No changes in dietary group

Protein restrictive diet

EXPERIMENTAL

reduced protein diet

Other: Protein restrictive diet

Interventions

Protein restrictive diet OTHER

To begin a reduced protein diet

Protein restrictive diet

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (3)

• Fontana L, Cummings NE, Arriola Apelo SI, Neuman JC, Kasza I, Schmidt BA, Cava E, Spelta F, Tosti V, Syed FA, Baar EL, Veronese N, Cottrell SE, Fenske RJ, Bertozzi B, Brar HK, Pietka T, Bullock AD, Figenshau RS, Andriole GL, Merrins MJ, Alexander CM, Kimple ME, Lamming DW. Decreased Consumption of Branched-Chain Amino Acids Improves Metabolic Health. Cell Rep. 2016 Jul 12;16(2):520-530. doi: 10.1016/j.celrep.2016.05.092. Epub 2016 Jun 23.

  PMID: 27346343 BACKGROUND

• Trevino-Villarreal JH, Reynolds JS, Bartelt A, Langston PK, MacArthur MR, Arduini A, Tosti V, Veronese N, Bertozzi B, Brace LE, Mejia P, Trocha K, Kajitani GS, Longchamp A, Harputlugil E, Gathungu R, Bird SS, Bullock AD, Figenshau RS, Andriole GL, Thompson A, Heeren J, Ozaki CK, Kristal BS, Fontana L, Mitchell JR. Dietary protein restriction reduces circulating VLDL triglyceride levels via CREBH-APOA5-dependent and -independent mechanisms. JCI Insight. 2018 Nov 2;3(21):e99470. doi: 10.1172/jci.insight.99470.

  PMID: 30385734 BACKGROUND

• Eitan E, Tosti V, Suire CN, Cava E, Berkowitz S, Bertozzi B, Raefsky SM, Veronese N, Spangler R, Spelta F, Mustapic M, Kapogiannis D, Mattson MP, Fontana L. In a randomized trial in prostate cancer patients, dietary protein restriction modifies markers of leptin and insulin signaling in plasma extracellular vesicles. Aging Cell. 2017 Dec;16(6):1430-1433. doi: 10.1111/acel.12657. Epub 2017 Sep 17.

  PMID: 28921841 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Luigi Fontana, MD,PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Valeria Tosti, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2012
• First Posted: September 25, 2012
• Study Start: January 1, 2011
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 26, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)