Brief Title
Randomized, Phase II Clinical Trial of Sulforaphane in Bladder Cancer Chemoprevention
Official Title
Randomized, Phase II Clinical Trial of Sulforaphane in Bladder Cancer Chemoprevention
Brief Summary
The main purpose of this study is to see if Prostaphane is effective and can help reduce the
progression of bladder cancer. Researchers also want to find out if Prostaphane is safe and
tolerable, and to evaluate how Prostaphane works to reduce the progression of bladder cancer.
This study will compare Prostaphane with a placebo to see if taking Prostaphane is better
than taking a placebo. A placebo is a pill that looks like Prostaphane but has no drug or
other active ingredients in it.
The study will be presented to eligible patients by the patient's surgeon at the time when an
appointment is made for cystoscopy for suspicion of bladder cancer (BC) or to confirm BC
diagnosis.
Detailed Description
The study will be presented to eligible patients by the patient's surgeon at the time when an
appointment is made for cystoscopy for suspicion of bladder cancer (BC) or to confirm BC
diagnosis.
Participants will be asked to spend 21 to 30 days in this study. The study will be conducted
during the time from when the participant is diagnosed with bladder cancer to when they
undergo a surgical procedure for the treatment or removal of their bladder cancer. The
surgical procedure is done as a part of their regular medical care. Participants will be
asked to come for 1 additional visit as part of this research study at the midpoint between
their biopsy and surgery.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Magnitude of Change
Secondary Outcome
Effectiveness of Sulforaphane vs. Placebo
Condition
Bladder Cancer
Intervention
Sulforaphane Administration
Study Arms / Comparison Groups
Sulforaphane Plus Surgery
Description: Sulforaphane Administration prior to bladder cancer surgery.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
0
Start Date
April 2020
Completion Date
December 2022
Primary Completion Date
December 2021
Eligibility Criteria
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Nagi Kumar, Ph.D, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03517995
Organization ID
MCC-19574
Responsible Party
Sponsor
Study Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
National Institutes of Health (NIH)
Study Sponsor
Nagi Kumar, Ph.D, Principal Investigator, H. Lee Moffitt Cancer Center and Research Institute
Verification Date
February 2020