Sulphate Accumulation in Prostate (SAP)
A Pre-Biopsy Window of Opportunity Trial to Measure Sulphate Levels in Human Prostate After Broccoli Consumption
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Norfolk
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Norwich, Norfolk, Storbritannia, NR4 7UA
- Institute of Food Research
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Sulphate level
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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ADP
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Richard Mithen, PhD, Quadram Institute Bioscience
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IFR01/2016
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