Biomarkers of Sulforaphane/Broccoli Sprout Extract in Prostate Cancer
Condition: Prostate Cancer
Study Type: Interventional
Clinical Trials Identifier NCT 8-digits: NCT03665922
Sponsor: University of Pittsburgh
- Age: minimum 18 Years maximum 90 Years
- Gender: Male
- Men ≥ 18 years of age scheduled to undergo radical prostatectomy as standard of care for a diagnosis of prostate adenocarcinoma.
- Subjects willing to take oral placebo or BroccoMax® pills (4 capsules twice daily after breakfast and dinner) on a daily basis for 4 weeks prior to prostatectomy. Subjects have the ability to swallow BroccoMax® or placebo pills.
- Subjects in good health per investigator evaluation with liver enzyme and blood count values within the following ranges: White blood cells ≥ 3,000/mL Total bilirubin ≤ 1.5 x Upper Limits of Normal (ULN) Aspartate Aminotransferase (AST (SGOT))/ Alanine Aminotransferase (ALT (SGPT)) ≤ 2.5 x ULN Blood Urea Nitrogen (BUN) and serum creatinine ≤ 1.5 x ULN
- Subjects willing to abstain from dietary sources of glucosinolates and isothiocyanates (see Appendix) for the duration of the study (4 weeks)
- Subjects must be fully informed of the investigational nature of this study and must sign a written informed consent in accordance within institutional and regulatory guidelines
- Subjects ineligible to undergo prostatectomy due to co-morbidities.
- Subjects with a second malignancy or any other cancer at least 3 years following definitive treatment with no evidence of disease, except for adequately treated basal cell or squamous cell skin cancer.
- Subjects with malabsorption issues or gastrointestinal ailments than can interfere with the ability to adequately absorb SFN.
- Subjects with prior or concurrent androgen deprivation therapy with Luteinizing hormone-releasing hormone (LHRH) agonist or antagonists
- Subjects taking any other investigational agent, dietary supplement or herbal supplement or participating in clinical studies involving investigational agents
- Subjects with clinically significant comorbid diseases including active infection, uncontrolled angina, New York Heart Assoc. (NYHA) class III or IV heart failure, uncontrolled or uncontrollable hypertension, severe diabetes with complications, chronic liver disease.
- Subjects with prior history of known intolerance or allergic reactions attributed to cruciferous vegetables or specific fillers used in the placebo.
View trial on ClinicalTrials.gov