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

NCT03517995 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: MCC-19574
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Bladder Cancer; Bladder Tumor; Urothelial Carcinoma

Keywords

primary bladder tumor; non-muscle invasive bladder tumor; muscle invasive bladder tumor; sulforaphane; chemoprevention

Outcome Measures

Primary Outcomes (1)

• Magnitude of Change

  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.

  Up to 30 days

Secondary Outcomes (6)

• Effectiveness of Sulforaphane vs. Placebo

  End of study, approximately 30 days

• Occurrence of Adverse Events per Study Arm

  End of study, approximately 30 days

• Mid-study Bioavailability of Sulforaphane

  Mid-study, approximately 15 days

• End of Study Bioavailability of Sulforaphane

  End of study, approximately 30 days

• Adherence of Sulforaphane vs. Placebo

  End of study, approximately 30 days

Study Arms (2)

Sulforaphane Plus Surgery

ACTIVE COMPARATOR

Sulforaphane Administration prior to bladder cancer surgery.

Drug: Sulforaphane Administration; Procedure: Standard of Care Surgery

Placebo Plus Surgery

PLACEBO COMPARATOR

Placebo Administration prior to bladder cancer surgery.

Other: Placebo Administration; Procedure: Standard of Care Surgery

Interventions

Sulforaphane Administration DRUG

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

Also known as: Prostaphane

Sulforaphane Plus Surgery

Placebo Administration OTHER

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

Placebo Plus Surgery

Standard of Care Surgery 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.

Also known as: post study treatment surgery, bladder cancer surgery

Placebo Plus Surgery; Sulforaphane Plus Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• National Institutes of Health (NIH): collaborator
• Johns Hopkins University: collaborator

Study Sites (2)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

James A. Haley Veteran's Administration Hospital

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Nagi Kumar, Ph.D

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: May 8, 2018
• Study Start: April 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: May 28, 2020

Record last verified: 2020-02

Locations

US (2)