What side effects are associated with this type of intervention?

Common treatments for prostate cancer include hormone therapy, chemotherapy, and dietary supplements like sulforaphane. Hormone therapy can cause side effects such as hot flashes, reduced libido, and osteoporosis. Chemotherapy, particularly with taxanes like docetaxel and cabazitaxel, can lead to neuropathy, alopecia, and immunosuppression. Dietary supplements like sulforaphane are generally well-tolerated but can sometimes cause gastrointestinal discomfort.

What prior FDA approvals exist?

FDA-approved treatments for prostate cancer include androgen receptor signaling inhibitors like enzalutamide, apalutamide, and darolutamide, which are used in nonmetastatic castration-resistant prostate cancer (CRPC). Taxane chemotherapies such as docetaxel and cabazitaxel are approved for metastatic CRPC. Additionally, radioligand therapy with lutetium Lu 177 vipivotide tetraxetan is available for prostate-specific membrane antigen-positive metastatic CRPC. While these treatments are well-established, there is ongoing research into complementary therapies like sulforaphane, found in BroccoMax®, which is being studied for its potential impact on prostate cancer-related chemicals.

What other types of research exist?

Promising novel alternatives for prostate cancer treatment in 2024 include: 1) Darolutamide combined with androgen deprivation therapy (ADT) and docetaxel for high-risk/high-volume metastatic castration-sensitive prostate cancer (CSPC). 2) Lutetium-177-PSMA-617, a radioligand therapy for metastatic castration-resistant prostate cancer (CRPC). 3) BAT (Bipolar Androgen Therapy) for CRPC, particularly in patients who have progressed on enzalutamide or abiraterone. These treatments have shown efficacy in recent clinical trials and offer new hope for prostate cancer patients.

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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

Must not have

Subjects with prior or concurrent androgen deprivation therapy with Luteinizing hormone-releasing hormone (LHRH) agonist or antagonists

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 months

Summary

This trial tests if a broccoli extract supplement called BroccoMax® can change chemicals that feed prostate cancer. Patients with prostate cancer will take the supplement before their surgery. The supplement contains sulforaphane, which may help by disrupting the cancer's food supply. Sulforaphane shows promise in managing biochemical recurrences in prostate cancer after radical prostatectomy.

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.

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.

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

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I am a man over 18 scheduled for surgery to remove prostate cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with hormone therapy for my cancer.

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I do not have severe heart issues, uncontrolled high blood pressure, serious diabetes complications, or chronic liver disease.

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I cannot have prostate surgery due to other health issues.

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I do not have issues absorbing nutrients due to stomach or bowel problems.

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I am not taking any experimental drugs or supplements, nor am I in another clinical trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Palmitic Acid Reduction

Secondary study objectives

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.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Sulforaphane, a compound found in broccoli, works by inducing anticarcinogenic protective enzymes, which can alter the chemical environment that supports prostate cancer growth. This mechanism is significant for prostate cancer patients as it offers a dietary-based approach to potentially reduce cancer progression. Other common treatments include androgen deprivation therapy (ADT), which reduces levels of male hormones that can fuel cancer growth, and chemotherapy, which targets rapidly dividing cancer cells. Understanding these mechanisms helps patients and doctors make informed decisions about combining dietary supplements with conventional treatments to optimize outcomes.

Phytotherapeutic interventions in the management of biochemically recurrent prostate cancer: a systematic review of randomised trials.Sixth joint meeting of J-CaP and CaPSURE--a multinational perspective on prostate cancer management and patient outcomes.Consumption of dietary supplements and over-the-counter and prescription medications in men participating in the Prostate Cancer Prevention Trial at an academic center.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,924 Previous Clinical Trials

41,017,912 Total Patients Enrolled

515 Trials studying Prostate Cancer

332,921 Patients Enrolled for Prostate Cancer

University of PittsburghLead Sponsor

1,789 Previous Clinical Trials

16,359,584 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