Sulphate Accumulation in Prostate

Prostate Cancer Clinical Trial

— SAP  

Official title:

A Pre-Biopsy Window of Opportunity Trial to Measure Sulphate Levels in Human Prostate After Broccoli Consumption

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02821728
• Other study ID #: IFR01/2016
• Status: Completed
• Phase: N/A
• First received: June 21, 2016
• Last updated: June 1, 2017
• Start date: April 2016
• Est. completion date: April 2017

Study information

• Verified date: June 2017
• Source: Quadram Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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 5a-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

Related Conditions & MeSH terms

• Prostate Cancer

Intervention

Dietary Supplement:
• Dietary intervention
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.

Other:
• Normal diet
Participants in this group will continue with their normal diet up until the day of their scheduled template prostate biopsy.

Locations

Country	Name	City	State
United Kingdom	Institute of Food Research	Norwich	Norfolk

Sponsors (2)

Lead Sponsor	Collaborator
Quadram Institute	Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sulphate level	Sulphate levels will be measured in biopsy tissue samples from both prostate and adipose (fat) tissues.	Biopsy on a single occasion at = 4 weeks
Secondary	ADP	Adenosine diphosphate (ADP) levels will be measured in biopsy tissue samples from both prostate and adipose (fat) tissues.	Biopsy on a single occasion at = 4 weeks
Secondary	Redox status of phosphatase proteins	The redox status of phosphatase proteins, including the tumour suppressor PTEN will be assessed in biopsy tissue samples from the prostate gland.	Biopsy on a single occasion at = 4 weeks