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Does Protein Restriction Inhibit Prostrate Cancer Growth

24. marts 2021 opdateret af: Washington University School of Medicine

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

65

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Missouri
      • Saint Louis, Missouri, Forenede Stater, 63110
        • Washington University School of Medicine

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Han

Beskrivelse

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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Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Control
No changes in dietary group
Eksperimentel: Protein restrictive diet
reduced protein diet
To begin a reduced protein diet

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Group1--Expression of genes and proteins of the PI-3K/Akt/mTOR pathway. Group 2--PSA values obtained every three months
Tidsramme: 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.
group 1- (4-6 weeks), group 2 -(52 weeks)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Valeria Tosti, MD, Washington University School of Medicine
  • Ledende efterforsker: Luigi Fontana, MD,PhD, Washington University School of Medicine

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2011

Primær færdiggørelse (Faktiske)

1. marts 2015

Studieafslutning (Faktiske)

1. marts 2015

Datoer for studieregistrering

Først indsendt

7. september 2012

Først indsendt, der opfyldte QC-kriterier

20. september 2012

Først opslået (Skøn)

25. september 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. marts 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. marts 2021

Sidst verificeret

1. marts 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 201011804

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Plan to publish

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Protein restrictive diet

Abonner