NCT03665922Completed
Biomarkers of Sulforaphane/Broccoli Sprout Extract in Prostate Cancer
Source: ClinicalTrials.gov · Last updated 12 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 39 (actual)
- First submitted
- 5 Sept 2018
- Start date
- 1 May 2019
- Primary completion date
- 30 Jun 2024
- Lead sponsor
- University of Pittsburgh
- Diseases
- Prostate cancer
- NCT number
- NCT03665922
What you commit to
- Study type: Interventional
- Participants enrolled: 39
- From 1 May 2019 to the primary completion date, 30 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects with a second malignancy or any other cancer at least 3 years following definitive treatment with no evidence of disease, except for adequately treated basal cell or squamous cell skin cancer.
- Subjects with prior or concurrent androgen deprivation therapy with Luteinizing hormone-releasing hormone (LHRH) agonist or antagonists
- Subjects taking any other investigational agent, dietary supplement or herbal supplement or participating in clinical studies involving investigational agents
- Subjects with prior history of known intolerance or allergic reactions attributed to cruciferous vegetables or specific fillers used in the placebo.
Other illness
- Subjects with clinically significant comorbid diseases including active infection, uncontrolled angina, New York Heart Assoc. (NYHA) class III or IV heart failure, uncontrolled or uncontrollable hypertension, severe diabetes with complications, chronic liver disease.
Other
- Subjects ineligible to undergo prostatectomy due to co-morbidities.
- Subjects with malabsorption issues or gastrointestinal ailments than can interfere with the ability to adequately absorb SFN.
Who the study is looking for
- Men ≥ 18 years of age scheduled to undergo radical prostatectomy as standard of care for a diagnosis of prostate adenocarcinoma.
- Subjects willing to take oral placebo or BroccoMax® pills (4 capsules twice daily after breakfast and dinner) on a daily basis for 4 weeks prior to prostatectomy. Subjects have the ability to swallow BroccoMax® or placebo pills.
- Subjects in good health per investigator evaluation with liver enzyme and blood count values within the following ranges:
- White blood cells ≥ 3,000/mL Total bilirubin ≤ 1.5 x Upper Limits of Normal (ULN) Aspartate Aminotransferase (AST (SGOT))/ Alanine Aminotransferase (ALT (SGPT)) ≤ 2.5 x ULN Blood Urea Nitrogen (BUN) and serum creatinine ≤ 1.5 x ULN
- Subjects willing to abstain from dietary sources of glucosinolates and isothiocyanates (see Appendix) for the duration of the study (4 weeks)
- Subjects must be fully informed of the investigational nature of this study and must sign a written informed consent in accordance within institutional and regulatory guidelines
Age in the registry: 18 years to 90 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shadyside Urology Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.