NCT03517995

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Sulforaphane Administration	1 capsule (10 mg Prostaphane) taken two times per day (2 capsules, 20 mg Prostaphane total).
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.

Timeline

• Start date: 2020-04-01
• Primary completion: 2021-12-01
• Completion: 2022-12-01
• First posted: 2018-05-08
• Last updated: 2020-05-28

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study