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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03517995
Recruitment Status : Not yet recruiting
First Posted : May 8, 2018
Last Update Posted : February 6, 2020
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Johns Hopkins University
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Tracking Information
First Submitted Date  ICMJE April 26, 2018
First Posted Date  ICMJE May 8, 2018
Last Update Posted Date February 6, 2020
Estimated Study Start Date  ICMJE April 2020
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2018)
Magnitude of Change [ Time Frame: Up to 30 days ]
Magnitude of change in Intermediate Endpoint Biomarkers (IEBs) of proliferation (Ki-67 expressing cells- an independent marker of poor prognosis in bladder cancer (BC)) from baseline to end of treatment with 20 mgs Prostaphane® [Nutinov Labs, France] containing 200 μmol of Sulforaphane (SFN) a day at 3-4 weeks (maximum 30 days) in BC cells and benign/adjacent cells.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2018)
  • Effectiveness of Sulforaphane vs. Placebo [ Time Frame: End of study, approximately 30 days ]
    Effectiveness of SFN at this dose (vs. placebo) as indicated by modulation of other IEBs of proliferation, apoptosis and phase II enzymes, as well as the potential molecular mechanism of SFN, we will measure changes in: (i) BC histology grade; (ii) labeling index of a sensitive biomarker that is a member of DNA replication origin licensing complex, Mcm2; (iii) apoptosis (Caspase-3); (iv) Phase II enzymes (glutathione transferases, epoxide hydrolase, Nicotinamide adenine dinucleotide phosphate (NAD(P)H): quinone reductase, and glucuronosyltransferases); (v) Nrf2 and Transcription factor (NF-kB) signaling, from baseline to end of treatment in BC cells and benign/adjacent cells.
  • Occurrence of Adverse Events per Study Arm [ Time Frame: End of study, approximately 30 days ]
    Safety of SFN at this dose (vs. Placebo) as indicated by incidence of adverse events and toxicities, monitored using Common Toxicity Criteria version 5.0, complete blood count (CBC), and complete metabolic panel (CMP) from baseline at mid-point and at end of trial.
  • Mid-study Bioavailability of Sulforaphane [ Time Frame: Mid-study, approximately 15 days ]
    Bioavailability, of SFN at this dose vs. Placebo. Investigators will measure change in SFN in plasma and bladder tissue from baseline, at mid-point and at end of study.
  • End of Study Bioavailability of Sulforaphane [ Time Frame: End of study, approximately 30 days ]
    Bioavailability, of SFN at this dose vs. Placebo. Investigators will measure change in SFN in plasma and bladder tissue from baseline, at mid-point and at end of study.
  • Adherence of Sulforaphane vs. Placebo [ Time Frame: End of study, approximately 30 days ]
    Adherence based on pill counts and diet and pill logs from baseline.
  • Acceptability of Sulforaphane vs. Placebo [ Time Frame: End of study, approximately 30 days ]
    Acceptability based on pill counts and diet and pill logs from baseline.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized, Phase II Clinical Trial of Sulforaphane in Bladder Cancer Chemoprevention
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Bladder Cancer
  • Bladder Tumor
  • Urothelial Carcinoma
Intervention  ICMJE
  • Drug: Sulforaphane Administration
    1 capsule (10 mg Prostaphane) taken two times per day (2 capsules, 20 mg Prostaphane total).
    Other Name: Prostaphane
  • Other: Placebo Administration
    1 capsule (placebo) taken two times per day (2 capsules total).
  • Procedure: Standard of Care Surgery
    The study will be conducted during the time from when participants are 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.
    Other Names:
    • post study treatment surgery
    • bladder cancer surgery
Study Arms  ICMJE
  • Active Comparator: Sulforaphane Plus Surgery
    Sulforaphane Administration prior to bladder cancer surgery.
    Interventions:
    • Drug: Sulforaphane Administration
    • Procedure: Standard of Care Surgery
  • Placebo Comparator: Placebo Plus Surgery
    Placebo Administration prior to bladder cancer surgery.
    Interventions:
    • Other: Placebo Administration
    • Procedure: Standard of Care Surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 26, 2018)
135
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03517995
Other Study ID Numbers  ICMJE MCC-19574
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party H. Lee Moffitt Cancer Center and Research Institute
Study Sponsor  ICMJE H. Lee Moffitt Cancer Center and Research Institute
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • Johns Hopkins University
Investigators  ICMJE
Principal Investigator: Nagi Kumar, Ph.D H. Lee Moffitt Cancer Center and Research Institute
PRS Account H. Lee Moffitt Cancer Center and Research Institute
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP