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Sulphate Accumulation in Prostate (SAP)

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ClinicalTrials.gov Identifier: NCT02821728
Recruitment Status : Completed
First Posted : July 4, 2016
Last Update Posted : June 2, 2017
Sponsor:
Collaborator:
Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
Information provided by (Responsible Party):
Quadram Institute Bioscience

Tracking Information
First Submitted Date  ICMJE June 21, 2016
First Posted Date  ICMJE July 4, 2016
Last Update Posted Date June 2, 2017
Study Start Date  ICMJE April 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2016)
Sulphate level [ Time Frame: Biopsy on a single occasion at ≥ 4 weeks ]
Sulphate levels will be measured in biopsy tissue samples from both prostate and adipose (fat) tissues.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02821728 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2016)
  • ADP [ Time Frame: Biopsy on a single occasion at ≥ 4 weeks ]
    Adenosine diphosphate (ADP) levels will be measured in biopsy tissue samples from both prostate and adipose (fat) tissues.
  • Redox status of phosphatase proteins [ Time Frame: Biopsy on a single occasion at ≥ 4 weeks ]
    The redox status of phosphatase proteins, including the tumour suppressor PTEN will be assessed in biopsy tissue samples from the prostate gland.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sulphate Accumulation in Prostate
Official Title  ICMJE A Pre-Biopsy Window of Opportunity Trial to Measure Sulphate Levels in Human Prostate After Broccoli Consumption
Brief 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.
Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Normal diet
    No dietary intervention
    Intervention: Other: Normal diet
  • Experimental: Dietary intervention
    3 portions of broccoli soup per week
    Intervention: Dietary Supplement: Dietary intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 29, 2016)
18
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2017
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02821728
Other Study ID Numbers  ICMJE IFR01/2016
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Quadram Institute Bioscience
Study Sponsor  ICMJE Quadram Institute Bioscience
Collaborators  ICMJE Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
Investigators  ICMJE
Principal Investigator: Richard Mithen, PhD Quadram Institute Bioscience
PRS Account Quadram Institute Bioscience
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP