Randomized, Phase II Clinical Trial of Sulforaphane in Bladder Cancer Chemoprevention

This is an interventional prevention trial for Bladder Cancer focused on measuring primary bladder tumor, non-muscle invasive bladder tumor, muscle invasive bladder tumor, sulforaphane, chemoprevention Read More

Inclusion Criteria:

• Men and women; age ≥18 years; evidence of non-muscle invasive or muscle invasive primary bladder tumor (urothelial carcinoma +/- variant histology) discovered on cystoscopy or radiologic imaging performed within 60 days of randomization; with no evidence of distant metastases; planned Transurethral Resection+B21 (TURBT), cystoscopy with biopsies or cystectomy (total or partial);
• Absent prior pelvic radiation; normal organ function;
• Absent neoadjuvant chemotherapy (refusal or ineligibility); (the participant may have prior intravesical treatment exposure (including Bacillus Calmette-Guerin (BCG), mitomycin, gemcitabine, valrubicin, docetaxel, etc.) for bladder cancer (BC) (excluding primary bladder radiation therapy) provided that treatment was completed greater than 30 days prior to the patient's randomization visit);
• Non-smokers (urinary cotinine tested);
• Agree to restrict dietary sources of Sulforaphane (SFN) to 3 or 5 servings/week and abstain from consuming SFN supplements beginning three days prior to start of study and throughout duration of the study;
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
• Willing to discontinue current vitamin/mineral supplement use and substitute with a standard multivitamin supplement provided for the study;
• Willing to use an effective method of contraception, if the partner is of child-bearing age, while on study;
• Willing to comply with proposed visit and treatment schedule;
• Able to understand and willing to sign a written informed consent document;
• Participants must have normal organ and marrow function.

Exclusion Criteria:

• Evidence of other cancers (excluding non-melanoma skin cancer) or metastatic disease;
• Prior pelvic radiation; concurrent systemic chemotherapy for any other cancer, excluding non-melanoma skin cancer;
• Any treatment for the bladder tumor other than intravesical therapy;
• Prior treatment with a known histone deacetylase inhibitor (including but not limited to valproic acid, suberoylanilide hydroxamic acid (SAHA), Panobinostat (LBH589), etc.) within 6 months prior to starting study treatment or while on study therapy;
• Current treatment with warfarin;
• Use of dietary supplements or herbal remedies which may affect the study outcome - unless the participant is willing to discontinue taking them for 1 month prior to starting study;
• Usual consumption of > 5 servings per week of brassica vegetables;
• Gastrointestinal ailments which would interfere with the ability to adequately absorb SFN;
• Allergy/known intolerance to cruciferous vegetables;
• Used antibiotics (more than 3 doses) within 10 days prior to study (day -14 prior to study randomization);
• Current smoker.