We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sulphate Accumulation in Prostate (SAP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02821728
First Posted: July 4, 2016
Last Update Posted: June 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
Information provided by (Responsible Party):
Quadram Institute
  Purpose
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.

Condition Intervention
Prostate Cancer Dietary Supplement: Dietary intervention Other: Normal diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Pre-Biopsy Window of Opportunity Trial to Measure Sulphate Levels in Human Prostate After Broccoli Consumption

Resource links provided by NLM:


Further study details as provided by Quadram Institute:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 18
Study Start Date: April 2016
Study Completion Date: April 2017
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Normal diet
No dietary intervention
Other: Normal diet
Participants in this group will continue with their normal diet up until the day of their scheduled template prostate biopsy.
Experimental: Dietary intervention
3 portions of broccoli soup per week
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.

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02821728


Locations
United Kingdom
Institute of Food Research
Norwich, Norfolk, United Kingdom, NR4 7UA
Sponsors and Collaborators
Quadram Institute
Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
Investigators
Principal Investigator: Richard Mithen, PhD Quadram Institute
  More Information

Responsible Party: Quadram Institute
ClinicalTrials.gov Identifier: NCT02821728     History of Changes
Other Study ID Numbers: IFR01/2016
First Submitted: June 21, 2016
First Posted: July 4, 2016
Last Update Posted: June 2, 2017
Last Verified: June 2017

Keywords provided by Quadram Institute:
Prostate
Sulphate
ATP
PTEN