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Chemoprevention Agent

Broccoli Supplement for Prostate Cancer

N/A
Waitlist Available
Led By Bruce Jacobs, MD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men ≥ 18 years of age scheduled to undergo radical prostatectomy for a diagnosis of prostate adenocarcinoma
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 months
Awards & highlights

Study Summary

This trial will test whether taking a broccoli supplement called BroccoMax can change the chemicals that fuel prostate cancer.

Who is the study for?
This trial is for men over 18 with prostate adenocarcinoma scheduled for surgery. Participants must be in good health, able to swallow pills, and willing to avoid certain foods. They can't join if they have severe diseases like heart failure or uncontrolled diabetes, other cancers within the last 3 years (except some skin cancers), malabsorption issues, prior hormone therapy for cancer, or allergies to cruciferous vegetables.Check my eligibility
What is being tested?
The study tests if BroccoMax®, a broccoli sprout extract supplement containing sulforaphane (SFN), affects prostate cancer biomarkers. Men will take either BroccoMax® or placebo pills twice daily for four weeks before their surgery.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects may include digestive discomfort due to high fiber content in broccoli extracts and possible allergic reactions in individuals sensitive to cruciferous vegetables.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a man over 18 scheduled for surgery to remove prostate cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Palmitic Acid Reduction
Secondary outcome measures
Evaluation of Prostate adenocarcinoma tissue by immunohistochemistry.
Evaluation of prostate adenocarcinoma levels of fatty acid metabolism intermediates
Evaluation of safety of BroccoMax® (side effects or adverse events)
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BroccoMax®Experimental Treatment1 Intervention
Following randomization, subjects will begin to take four BroccoMax® tablets 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.
Group II: PlaceboPlacebo Group1 Intervention
Following randomization, subjects will begin to take four placebo tablets in the morning with breakfast and four tablets in the evening with dinner.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,607 Previous Clinical Trials
40,914,123 Total Patients Enrolled
559 Trials studying Prostate Cancer
507,115 Patients Enrolled for Prostate Cancer
University of PittsburghLead Sponsor
1,712 Previous Clinical Trials
16,346,372 Total Patients Enrolled
9 Trials studying Prostate Cancer
1,008 Patients Enrolled for Prostate Cancer
Bruce Jacobs, MDPrincipal Investigator - University of Pittsburgh
Jameson Hospital, Magee-Women's Hospital of UPMC, Somerset Hospital, UPMC Hamot, UPMC Horizon-Greenville, UPMC McKeesport, UPMC Presbyterian, UPMC Shadyside
Vanderbilt University School Of Medicine (Medical School)
1 Previous Clinical Trials
208 Total Patients Enrolled
1 Trials studying Prostate Cancer
208 Patients Enrolled for Prostate Cancer

Media Library

BroccoMax® (Chemoprevention Agent) Clinical Trial Eligibility Overview. Trial Name: NCT03665922 — N/A
Prostate Cancer Research Study Groups: BroccoMax®, Placebo
Prostate Cancer Clinical Trial 2023: BroccoMax® Highlights & Side Effects. Trial Name: NCT03665922 — N/A
BroccoMax® (Chemoprevention Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03665922 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there unfilled vacancies for participants in this trial?

"This research is currently being conducted. It was initially posted on May 1st 2019 and the details were modified most recently on October 7th 2022, according to clinicaltrials.gov's records."

Answered by AI

Are there age restrictions on the participants of this research project?

"The age range of participants in this medical trial is 18 to 90 years old. There are 76 trials for minors, and 1315 studies that involve elderly patients."

Answered by AI

Who is the optimal candidate for enrollment in this experiment?

"This clinical trial is recruiting 40 volunteers between the ages of 18 and 90 who have recently been diagnosed with prostate cancer. To be eligible for participation, individuals must possess a White Blood Cell count ≥ 3,000/mL , Total Bilirubin ≤ 1.5 x Upper Limits of Normal (ULN), AST/ALT ≤ 2.5 x ULN, BUN + Serum Creatinine ≤1.5x ULN; in addition to being willing to take either BroccoMax® or placebo capsules twice daily for four weeks prior to surgery and abstaining from dietary sources of glucosinolates and isoth"

Answered by AI

What is the current sample size in this clinical research initiative?

"Yes, according to the clinicaltrials.gov page this trial is still in its recruitment stage. It was initially posted on May 1st 2019 and last modified on October 7th 2022. 40 patients will be recruited from a single location for participation."

Answered by AI
~5 spots leftby Dec 2024