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

NCT ID: NCT03517995

Last Updated: 2020-05-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-30
• Study Completion Date: 2022-12-31

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.

Conditions

Bladder Cancer; Bladder Tumor; Urothelial Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Sulforaphane Plus Surgery

Sulforaphane Administration prior to bladder cancer surgery.

Group Type: ACTIVE_COMPARATOR

Sulforaphane Administration

Intervention Type: DRUG

1 capsule (10 mg Prostaphane) taken two times per day (2 capsules, 20 mg Prostaphane total).

Standard of Care Surgery

Intervention Type: PROCEDURE

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.

Placebo Plus Surgery

Placebo Administration prior to bladder cancer surgery.

Group Type: PLACEBO_COMPARATOR

Placebo Administration

Intervention Type: OTHER

1 capsule (placebo) taken two times per day (2 capsules total).

Standard of Care Surgery

Intervention Type: PROCEDURE

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.

Interventions

Sulforaphane Administration

1 capsule (10 mg Prostaphane) taken two times per day (2 capsules, 20 mg Prostaphane total).

Intervention Type: DRUG

Placebo Administration

1 capsule (placebo) taken two times per day (2 capsules total).

Intervention Type: OTHER

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.

Intervention Type: PROCEDURE

Other Intervention Names

Prostaphane; post study treatment surgery; bladder cancer surgery

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nagi Kumar, Ph.D

Role: PRINCIPAL_INVESTIGATOR

H. Lee Moffitt Cancer Center and Research Institute

Locations

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

James A. Haley Veteran's Administration Hospital

Tampa, Florida, United States

Countries

United States

Other Identifiers

MCC-19574

Identifier Type: -

Identifier Source: org_study_id