Utilizing MRI to Study the Effect of Sulforaphane on Prostate Cancer
Ключови думи
Резюме
Описание
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.
Дати
| Последна проверка: | 10/31/2016 |
| Първо изпратено: | 03/22/2015 |
| Очаквано записване подадено: | 03/25/2015 |
| Първо публикувано: | 03/30/2015 |
| Изпратена последна актуализация: | 11/22/2016 |
| Последна актуализация публикувана: | 11/24/2016 |
| Действителна начална дата на проучването: | 01/31/2015 |
| Приблизителна дата на първично завършване: | 08/31/2016 |
| Очаквана дата на завършване на проучването: | 08/31/2016 |
Състояние или заболяване
Интервенция / лечение
Dietary Supplement: standard broccoli soup
Dietary Supplement: beneforte extra broccoli soup
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| 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) |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 18 Years Да се 18 Years |
| Полове, допустими за проучване | Male |
| Приема здрави доброволци | Да |
| Критерии | 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 |
Резултат
Първични изходни мерки
1. tumor size/blood flow [6 months]
Вторични изходни мерки
1. choline + creatine/citrate ratio [6 months]
2. citrate levels [6 months]
3. PSA levels [6 months]
4. GSTM1 genotype [6 months]
