Accumulation of Dietary Bioactives and Prostate Cancer

Study Overview
=================
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.

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

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Dietary Supplement: Allin
* Dietary Supplement: Sulforaphane
* Dietary Supplement: Placebo


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study arm 1<br>Allin capsules (x2) and Sulforaphane capsules (x2) once daily for 4 weeks | Dietary Supplement: Allin<br>* Dietary supplement<br>Dietary Supplement: Sulforaphane<br>* Dietary supplement<br>|
| Experimental: Study arm 2<br>Allin capsules (x2) and placebo capsules (x2) once daily for 4 weeks | Dietary Supplement: Allin<br>* Dietary supplement<br>Dietary Supplement: Placebo<br>* Dietary supplement<br>|
| Experimental: Study arm 3<br>Sulforaphane capsules (x2) and placebo capsules (x2) once daily for 4 weeks | Dietary Supplement: Sulforaphane<br>* Dietary supplement<br>Dietary Supplement: Placebo<br>* Dietary supplement<br>|
| Placebo Comparator: Study arm 4<br>Placebo capsules (x4) once daily for 4 weeks | Dietary Supplement: Placebo<br>* Dietary supplement<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of sulforaphane, alliin and their metabolites in prostate tissue as measured by mass spectrometry | Treatment-related differences in prostatic accumulation of Sulforaphane and Alliin, or their human and microbial metabolites, compared with placebo following a 4-week period of supplementation | 4 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2. Concentration of sulforaphane, alliin and their metabolites in in the transitional and peripheral zones of the prostate as measured by mass spectrometry | Treatment-related differences in spatial accumulation of Sulforaphane and Alliin, or their human and microbial metabolites, in the transitional and peripheral zones of the prostate compared with placebo following a 4-week period of supplementation | 4 weeks | 
| Urinary excretion of Sulforaphane and Alliin metabolites | Treatment-related differences in the urinary excretion levels of Sulforaphane and Alliin, or their human and microbial metabolites, following the initial 24-h period of supplementation | 24-hours | 
| 4. Changes in global gene expression in prostate tissue as measured using next generation sequencing | Treatment-related differences in global gene expression in the prostate tissue, following a 4-week period of supplementation with Sulforaphane and Alliin, compared with placebo | 4 weeks | 
| Microbiome profile | Treatment-related differences in prostatic tissue microbiome from the peripheral and transitional zones, following a 4-week period of supplementation with Sulforaphane and Alliin compared with placebo | 4 weeks | 
| Number of participants with glutathione S-transferase M1 (GSTM1) genotype null and positive | Changes in sulforaphane and alliin metabolites associated with Glutathione S-transferase M1 polymorphism (GSTM1 genotype) | After 4 weeks |