Clinical trial NCT04046653: Accumulation of Dietary Bioactives and Prostate Cancer
Official title: A Pre-biopsy Window of Opportunity Trial to Measure the Dietary Bioactive Levels in the Prostate Following an Intervention With Sulforaphane and Allin Dietary Supplements
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Quadram Institute Bioscience
Sponsor class: OTHER
Collaborators: name: Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
First posted: 2019-08-06
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Current research suggests that diets rich in multiple food types (such as broccoli, onions and garlic) are beneficial to our health and may reduce the risk of some cancers, including prostate cancer. The purpose of this study is to investigate the relationship between ingestion of the bioactive compounds from broccoli and garlic, and prostate metabolism.


Eligibility criteria: Inclusion Criteria:

* Scheduled for template biopsy of the prostate as part of routine investigation or staging for prostate cancer at the Norfolk and Norwich University Hospital
* 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 viral hepatitis
* Those allergic to any of the ingredients included in the supplements (including those with lactose intolerance)
* Those taking additional dietary supplements or herbal remedies that could affect the study outcome.
* 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.

Primary outcomes:
measure: Concentration of sulforaphane, alliin and their metabolites in prostate tissue as measured by mass spectrometry
timeFrame: 4 Weeks
Secondary outcomes:
measure: 2. Concentration of sulforaphane, alliin and their metabolites in in the transitional and peripheral zones of the prostate as measured by mass spectrometry
timeFrame: 4 weeks
measure: Urinary excretion of Sulforaphane and Alliin metabolites
timeFrame: 24-hours
measure: 4. Changes in global gene expression in prostate tissue as measured using next generation sequencing
timeFrame: 4 weeks
measure: Microbiome profile
timeFrame: 4 weeks
measure: Number of participants with glutathione S-transferase M1 (GSTM1) genotype null and positive
timeFrame: After 4 weeks
Other outcomes:
Locations:
city: Norwich
country: United Kingdom
facility: Quadram Institute Bioscience
state: Norfolk
Study officials:
affiliation: Quadram Institute Bioscience
name: Richard Mithen, pHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
name: Robert Mills, Dr
role: PRINCIPAL_INVESTIGATOR
References: