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Sulphate Accumulation in Prostate (SAP)

Q

Quadram Institute Bioscience

Status

Completed

Conditions

Prostate Cancer

Treatments

Other: Normal diet
Dietary Supplement: Dietary intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT02821728
IFR01/2016

Details and patient eligibility

About

This study evaluates whether a broccoli intervention (≥ 4 weeks) will result in differences in tissue sulphate levels in men scheduled for prostate biopsies. Comparisons will be made between participants randomised to the broccoli-rich diet and those randomised to the non-intervention arm.

Full description

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.

Enrollment

18 patients

Sex

Male

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

18 participants in 2 patient groups

Normal diet
Experimental group
Description:
No dietary intervention
Treatment:
Other: Normal diet
Dietary intervention
Experimental group
Description:
3 portions of broccoli soup per week
Treatment:
Dietary Supplement: Dietary intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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