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Utilizing MRI to Study the Effect of Sulforaphane on Prostate Cancer (ESCAPE-ING)

This study has been terminated.
(Problems with recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02404428
First Posted: March 31, 2015
Last Update Posted: November 25, 2016
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:
Cambridge University Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
Quadram Institute
  Purpose

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).


Condition Intervention
Prostate Cancer Dietary Supplement: Standard broccoli soup Dietary Supplement: Beneforte extra broccoli soup

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: Effect of Sulforaphane on Prostate CAncer PrEvention-imagING Evaluation

Resource links provided by NLM:


Further study details as provided by Quadram Institute:

Primary Outcome Measures:
  • tumor size/blood flow [ Time Frame: 6 months ]
    change in prostate tumor/blood flow size determined by MRI methods within the prostate gland


Secondary Outcome Measures:
  • choline + creatine/citrate ratio [ Time Frame: 6 months ]
    concentration of metabolites (choline + creatine/citrate ratio) in the prostate tissue determined by using MR spectroscopy

  • citrate levels [ Time Frame: 6 months ]
    concentration of citrate and associated metabolites in body fluids (blood, urine)

  • PSA levels [ Time Frame: 6 months ]
    plasma levels of prostate-specific antigen (PSA) and other blood markers

  • GSTM1 genotype [ Time Frame: 6 months ]
    Glutathione S-transferase Mu 1 (GSTM1) genotype or other relevant genotypes on mediating metabolite changes by diet


Enrollment: 5
Study Start Date: February 2015
Study Completion Date: September 2016
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: standard broccoli soup
one portion (300 g each) per week of a soup containing standard broccoli
Dietary Supplement: Standard broccoli soup
300g/week of standard broccoli soup consumed for a period of six months delivering standard level of glucoraphanin (sulforaphane precursor)
Experimental: beneforte extra broccoli soup
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
300g/week of beneforte extra broccoli soup consumed for a period of six months delivering enriched levels of glucoraphanin (sulforaphane precursor)

Detailed Description:
The study is a randomised double-blinded dietary intervention study. The study population will consist of men (n=20) aged 18-80 years with a BMI between 19.5 and 35 kg/m2 with low risk prostate cancer (prostate specific antigen [PSA] < 10ng/ml; Gleason grade 6; T category T1 or T2) or intermediate risk prostate cancer patients (PSA 10-20ng/ml; Gleason 7 (including selected 4+3 cases that will not be advised for radical prostatectomy; T category T1 or T2) who have visible lesions on MRI and have already decided to take up active surveillance/monitoring. The investigators chose these inclusion criteria because they reflect the population of men on active surveillance that the investigators are currently recruiting in the ESCAPE study (Effect of Sulforaphane on Prostate CAncer PrEvention; ClinicalTrials.gov Identifier: NCT01950143) via the Norfolk and Norwich University Hospital. Volunteers recruited onto this study will be randomly allocated to one of two arms in which they will be required to consume one portion of broccoli soup per week, delivering different levels of glucoraphanin (SF precursor) in each study arm. This will be part of their normal diet for 6 months. The two soups will contain standard broccoli (i), or glucoraphanin-enriched broccoli named for the study 'Beneforte extra' (ii). The study will involve MRI monitoring at baseline and after 6 months. In addition the investigators will collect blood and urine samples at baseline and after 6 months. The volunteers' habitual diet and physical activity will also be assessed during the intervention period.
  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:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 5α-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
  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): NCT02404428


Locations
United Kingdom
Cambridge University Hospitals NHS Foundation Trust_Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 0QQ
Sponsors and Collaborators
Quadram Institute
Cambridge University Hospitals NHS Foundation Trust
Investigators
Principal Investigator: Richard Mithen Quadram Institute
  More Information

Responsible Party: Quadram Institute
ClinicalTrials.gov Identifier: NCT02404428     History of Changes
Other Study ID Numbers: IFR02/2014
First Submitted: March 23, 2015
First Posted: March 31, 2015
Last Update Posted: November 25, 2016
Last Verified: November 2016

Keywords provided by Quadram Institute:
active surveillance
MRI
diet

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Sulforafan
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents