Utilizing MRI to Study the Effect of Sulforaphane on Prostate Cancer

NCT02404428 | Terminated

• 1 other identifier: IFR02/2014
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Prostate cancer is a major public health problem and there is a strong need of new preventive strategies based on drug and lifestyle interventions. It is now well-established that healthy eating patterns and increasing physical activity can prevent or delay prostate cancer progression. Intake of cruciferous vegetables (e.g. broccoli, cabbage, cauliflower, Brussels sprouts, kale) has been associated with decreased risk of prostate cancer progression; however the underlying biological mechanisms remain unknown. The investigators propose to undertake a pilot study on a group of men with early prostate cancer on active surveillance to determine whether a diet rich in broccoli will induce changes in tumor size and blood flow measured by conventional Magnetic Resonance Imaging (MRI) techniques. Men with early prostate cancer on active surveillance who have visible cancer lesions on MRI will be recruited onto this double-blinded randomized intervention and they will be asked to eat one portion of broccoli soup per week for 6 months. The investigators will test two varieties of broccoli (standard and 'Beneforte extra' broccoli) that are able to deliver two different levels of sulforaphane (SF), an active compound extensively studied for its potential anticancer properties. This study will involve MRI scans, blood and urine collection before and after a 6 month intervention period. This study design will not only allow us to observe diet-induced changes within the prostate but also at the systemic level. In addition, participant's lifestyle (habitual diet and physical activity) will be assessed by food diaries and exercise questionnaires. This study has been funded by Biotechnology and Biological Sciences Research Council (BBSRC) and Prostate Cancer foundation (PCF).

Conditions

Prostate Cancer

Keywords

active surveillance; MRI; diet

Outcome Measures

Primary Outcomes (1)

• tumor size/blood flow

  change in prostate tumor/blood flow size determined by MRI methods within the prostate gland

  6 months

Secondary Outcomes (4)

• choline + creatine/citrate ratio

  6 months

• citrate levels

  6 months

• PSA levels

  6 months

• GSTM1 genotype

  6 months

Study Arms (2)

standard broccoli soup

ACTIVE COMPARATOR

one portion (300 g each) per week of a soup containing standard broccoli

Dietary Supplement: Standard broccoli soup

beneforte extra broccoli soup

EXPERIMENTAL

one portion (300 g each) per week of a soup containing glucoraphanin-enriched broccoli named for the study 'Beneforte extra'

Dietary Supplement: Beneforte extra broccoli soup

Interventions

Standard broccoli soup DIETARY_SUPPLEMENT

300g/week of standard broccoli soup consumed for a period of six months delivering standard level of glucoraphanin (sulforaphane precursor)

standard broccoli soup

Beneforte extra broccoli soup DIETARY_SUPPLEMENT

300g/week of beneforte extra broccoli soup consumed for a period of six months delivering enriched levels of glucoraphanin (sulforaphane precursor)

beneforte extra broccoli soup

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Suitable for and have chosen AS as management for localised prostate cancer
• MRI visible detected lesion ≥0.5 cm in the axial plane, corresponding to the biopsy confirmed region of prostate cancer
• No contraindication to MR scanning
• Aged 18-80 years
• BMI between 19.5 and 35 kg/m2
• Smokers and non-smokers

You may not qualify if:

• α-reductase inhibitors or testosterone replacement medicines
• warfarin
• surgically implanted pelvic metalwork
• pacemakers or other implanted electronic devices not compatible with MRI
• contra-indications to gadolinium-based contrast agents (including patients with abnormal renal function)
• Glomerular Filtration Rate (GFR) \<60 ml/min
• claustrophobia
• allergies to any of the ingredients of the broccoli soups
• dietary supplements or herbal remedies which may affect the study outcome - unless the volunteer is willing to discontinue taking them for 1 month prior to starting study
• parallel participation in another research project that involves dietary intervention

Sponsors & Collaborators

• Quadram Institute Bioscience: lead
• Cambridge University Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

Cambridge University Hospitals NHS Foundation Trust_Addenbrooke's Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Richard Mithen

  Quadram Institute Bioscience

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2015
• First Posted: March 31, 2015
• Study Start: February 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: November 25, 2016

Record last verified: 2016-11

Locations

GB (1)