- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01692587
Does Protein Restriction Inhibit Prostrate Cancer Growth
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Missouri
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Saint Louis, Missouri, Estados Unidos, 63110
- Washington University School of Medicine
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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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Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: Control
No changes in dietary group
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Experimental: Protein restrictive diet
reduced protein diet
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To begin a reduced protein diet
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Group1--Expression of genes and proteins of the PI-3K/Akt/mTOR pathway. Group 2--PSA values obtained every three months
Periodo de tiempo: group 1- (4-6 weeks), group 2 -(52 weeks)
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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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group 1- (4-6 weeks), group 2 -(52 weeks)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Valeria Tosti, MD, Washington University School of Medicine
- Investigador principal: Luigi Fontana, MD,PhD, Washington University School of Medicine
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 201011804
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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