Accumulation of Dietary Bioactives and Prostate Cancer (ADaPT)

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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Dietary supplement: Allin; Dietary supplement: Sulforaphane; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Norfolk
    • Norwich, Norfolk, United Kingdom, NR4 7UQ
      • Quadram Institute Bioscience

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study arm 1; Allin capsules (x2) and Sulforaphane capsules (x2) once daily for 4 weeks	Dietary supplement: Allin; Dietary supplement; Dietary supplement: Sulforaphane; Dietary supplement
Experimental: Study arm 2; Allin capsules (x2) and placebo capsules (x2) once daily for 4 weeks	Dietary supplement: Allin; Dietary supplement; Dietary supplement: Placebo; Dietary supplement
Experimental: Study arm 3; Sulforaphane capsules (x2) and placebo capsules (x2) once daily for 4 weeks	Dietary supplement: Sulforaphane; Dietary supplement; Dietary supplement: Placebo; Dietary supplement
Placebo Comparator: Study arm 4; Placebo capsules (x4) once daily for 4 weeks	Dietary supplement: Placebo; Dietary supplement

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

Collaborators and Investigators

• Sponsor: Quadram Institute Bioscience
• Collaborators: Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
• Investigators: Principal Investigator: Richard Mithen, PhD, Quadram Institute Bioscience; Principal Investigator: Robert Mills, Dr, Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2019
• Primary Completion (Actual): January 12, 2020
• Study Completion (Actual): January 12, 2020

Study Registration Dates

• First Submitted: July 17, 2019
• First Submitted That Met QC Criteria: August 2, 2019
• First Posted (Actual): August 6, 2019

Study Record Updates

• Last Update Posted (Actual): November 18, 2020
• Last Update Submitted That Met QC Criteria: November 17, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Protective Agents; Anticarcinogenic Agents; Sulforaphane
• Other Study ID Numbers: QIB01/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No