- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02404428
Utilizing MRI to Study the Effect of Sulforaphane on Prostate Cancer (ESCAPE-ING)
Effect of Sulforaphane on Prostate CAncer PrEvention-imagING Evaluation
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).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Cambridge, United Kingdom, CB2 0QQ
- Cambridge University Hospitals NHS Foundation Trust_Addenbrooke's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: standard broccoli soup
one portion (300 g each) per week of a soup containing standard broccoli
|
300g/week of standard broccoli soup consumed for a period of six months delivering standard level of glucoraphanin (sulforaphane precursor)
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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'
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300g/week of beneforte extra broccoli soup consumed for a period of six months delivering enriched levels of glucoraphanin (sulforaphane precursor)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
tumor size/blood flow
Time Frame: 6 months
|
change in prostate tumor/blood flow size determined by MRI methods within the prostate gland
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
choline + creatine/citrate ratio
Time Frame: 6 months
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concentration of metabolites (choline + creatine/citrate ratio) in the prostate tissue determined by using MR spectroscopy
|
6 months
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citrate levels
Time Frame: 6 months
|
concentration of citrate and associated metabolites in body fluids (blood, urine)
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6 months
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PSA levels
Time Frame: 6 months
|
plasma levels of prostate-specific antigen (PSA) and other blood markers
|
6 months
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GSTM1 genotype
Time Frame: 6 months
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Glutathione S-transferase Mu 1 (GSTM1) genotype or other relevant genotypes on mediating metabolite changes by diet
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6 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Richard Mithen, Quadram Institute Bioscience
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IFR02/2014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Prostate Cancer
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Roswell Park Cancer InstituteRecruitingObesity | Overweight | Cancer Survivor | Prostate Adenocarcinoma | Stage I Prostate Cancer | Stage II Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage A Prostate Cancer | Stage... and other conditionsUnited States
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Sidney Kimmel Cancer Center at Thomas Jefferson...Regeneron Pharmaceuticals; Prostate Cancer FoundationWithdrawnStage III Prostate Cancer | Stage IV Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage IIIA Prostate Cancer | Stage IIIB Prostate Cancer | Stage IIIC Prostate Cancer
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Jonsson Comprehensive Cancer CenterProgenics Pharmaceuticals, Inc.TerminatedRandomized Trial of PSMA PET Scan Before Definitive Radiation Therapy for Prostate Cancer (PSMA-dRT)Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate Cancer AJCC v8 | Stage I Prostate...United States
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Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
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University of Southern CaliforniaNational Cancer Institute (NCI); SanofiTerminatedDiarrhea | Recurrent Prostate Cancer | Hormone-resistant Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
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Ryan Kohlbrenner, MDRadiological Society of North AmericaCompletedProstate Adenocarcinoma | Stage IV Prostate Cancer AJCC v8 | Prostate Carcinoma | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IVA Prostate Cancer AJCC v8 | Stage...United States
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Mayo ClinicNational Cancer Institute (NCI)WithdrawnStage I Prostate Cancer AJCC v8 | Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate...United States
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Barbara Ann Karmanos Cancer InstituteGenentech, Inc.CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
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Ohio State University Comprehensive Cancer CenterRiverside Methodist HospitalCompletedStage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
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Mayo ClinicNational Cancer Institute (NCI)TerminatedProstate Adenocarcinoma | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
Clinical Trials on Standard broccoli soup
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Quadram Institute BioscienceBiotechnology and Biological Sciences Research Council; Prostate Cancer FoundationCompleted
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Quadram Institute BioscienceBiotechnology and Biological Sciences Research Council; Prostate Cancer FoundationCompleted
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Quadram Institute BioscienceNorfolk and Norwich University Hospitals NHS Foundation TrustEnrolling by invitation
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University of UlsterUniversity of Reading; The James Hutton InstituteCompleted
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Ajinomoto Co., Inc.CompletedNutrition InterventionUnited States
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Unity Health TorontoCompleted
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University of NottinghamCompleted
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St. Boniface HospitalUniversity of Manitoba; Agriculture and Agri-Food CanadaActive, not recruiting
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Quadram Institute BioscienceBiotechnology and Biological Sciences Research Council; University of Reading; Technology Strategy Board, United Kingdom and other collaboratorsCompleted
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