Sulphate Accumulation in Prostate (SAP)
A Pre-Biopsy Window of Opportunity Trial to Measure Sulphate Levels in Human Prostate After Broccoli Consumption
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Epidemiological studies provide evidence for a negative correlation between prostate cancer and intake of cruciferous vegetables such as broccoli. Preliminary data from ongoing intervention trials carried out at the IFR suggest that dietary changes can directly influence the metabolic profile of prostate tissue. The most significant result observed to date is that of sulphate accumulation within the prostate. The additional sulphate is likely to drive synthesis of 3'-phosphoadenosine-5'-phosphosulfate, a universal sulphate donor, a process which would consume energy from ATP. A significant rise in levels of both ADP and phosphate has also been observed in prostate tissue from these studies, supporting the potential depletion of cellular ATP. Interestingly, the data indicate that the extent of ADP accumulation is negatively correlated with prostate cancer progression.
The investigators now propose to undertake a two arm parallel un-blinded study to test the hypothesis that a short-term intervention with broccoli soups will lead to the accumulation of sulphate and ADP in prostate tissue. A potential increase in glutathione metabolites indicating a change in redox status, and therefore functional status, of specific genes involved in tumour suppression (PTEN) will also be investigated.
Furthermore, the investigators aim to determine whether the accumulation of sulphate and ADP is specific to the prostate gland through the metabolic analyses of both prostate and non-prostate tissues.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Norfolk
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Norwich, Norfolk, Storbritannien, NR4 7UA
- Institute of Food Research
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Males
- Scheduled for TPB as part of routine investigation or staging for prostate cancer
- Aged 18-80 years
- BMI between 19.5 and 35 kg/m2
- Smokers and non-smokers
Exclusion Criteria:
- Those regularly taking 5α-reductase inhibitors or testosterone replacement medicines
- Those on warfarin treatment
- Those diagnosed with diabetes
- Those diagnosed with or suspected to be high-risk for human immunodeficiency virus (HIV) and/or hepatitis
- Those allergic to any of the ingredients of the broccoli soups
- Those taking dietary supplements or herbal remedies which may affect the study outcome. Please note that some supplements may not affect the study and this will be assessed on an individual basis
- Those that are unable to understand English or give informed consent
- Parallel participation in another research project that involves dietary intervention
- Any person related to or living with any member of the study team
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Normal diet
No dietary intervention
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Participants in this group will continue with their normal diet up until the day of their scheduled template prostate biopsy.
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Experimentell: Dietary intervention
3 portions of broccoli soup per week
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Participants in this group will consume three portions of broccoli and stilton soup per week for a minimum of four weeks before their scheduled template prostate biopsy.
The soup will be made with a specially cultivated broccoli known as Beneforte, which contains an enhanced dose of a substance called glucoraphanin.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Sulphate level
Tidsram: Biopsy on a single occasion at ≥ 4 weeks
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Sulphate levels will be measured in biopsy tissue samples from both prostate and adipose (fat) tissues.
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Biopsy on a single occasion at ≥ 4 weeks
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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ADP
Tidsram: Biopsy on a single occasion at ≥ 4 weeks
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Adenosine diphosphate (ADP) levels will be measured in biopsy tissue samples from both prostate and adipose (fat) tissues.
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Biopsy on a single occasion at ≥ 4 weeks
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Redox status of phosphatase proteins
Tidsram: Biopsy on a single occasion at ≥ 4 weeks
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The redox status of phosphatase proteins, including the tumour suppressor PTEN will be assessed in biopsy tissue samples from the prostate gland.
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Biopsy on a single occasion at ≥ 4 weeks
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Richard Mithen, PhD, Quadram Institute Bioscience
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IFR01/2016
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