NCT03665922

Biomarkers of Sulforaphane/Broccoli Sprout Extract in Prostate Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: Male
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This study will test whether oral intake of a dietary supplement called BroccoMax®, which is a special blend of broccoli extract containing a chemical called sulforaphane (hereafter abbreviated as SFN), may result in changes in chemicals that feed prostate cancer. BroccoMax® is available over the counter.

Detailed description

Eligible subjects will be randomly assigned to either BroccoMax® or placebo arm with a 1:1 randomization. Each subject will be given BroccoMax® equivalent to 4 weeks supply. Following randomization, subjects will begin to take four study tablets (BroccoMax® or placebo) in the morning with breakfast and four tablets in the evening with dinner. The eight BroccoMax® tablets will provide a daily internal dose of 64 mg of SFN. Baseline evaluation will be 28 days before scheduled prostatectomy, the same day of study drug dispensation, and will include. 1. Data collection on patient's medical history (which includes age, cancer history, review of medications, food intolerances and food habits), and concomitant medications. 2. Physical exam including height and weight measurements. 3. Blood (approximately 15 mL) will be collected in Serum Separator Tube-tiger tubes (SST)for determination of SFN and its metabolite levels and for biomarker analyses. 4. Spot urine collection (15 mL) for measuring SFN and its metabolite levels. 5. Four-week supply of study drug (BroccoMax® or Placebo) dispensation Day 28 ± 3 days (End of study evaluation) 1. Physical exam including height and weight measurements 2. Blood (approximately 15 mL) will be collected in SST-tiger tubes for determination of SFN and its metabolite levels and for biomarker analyses. 3. Spot urine collection (15 mL) for measuring SFN and its metabolite levels. 4. Adverse event assessment. 5. A portion of the prostate tumor after surgical resection will be fresh frozen in liquid nitrogen. 6. After pathological assessment is complete, tumor blocks or slides (6 or more) will be requested by the clinical research coordinator from the Health Sciences Tissue Bank of the University of Pittsburgh for biomarker analyses. Post-Treatment Follow-Up All study participants will have routine follow-up as determined by their treating urologist and/ or medical oncologist. This usually occurs 6 ± 2 weeks post-surgery and every 3 months thereafter. These are considered standard of care visits. The patient chart will be reviewed for their history and physical findings at these visits.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	BroccoMax®	Nutraceutical neoadjuvant
OTHER	Placebo	control

Timeline

• Start date: 2019-05-01
• Primary completion: 2024-06-30
• Completion: 2024-06-30
• First posted: 2018-09-11
• Last updated: 2025-02-12

Locations

1 site across 1 country: United States