Broccoli Supplement for Prostate Cancer

Overseen By Dawn McBride, RN

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Pittsburgh

Must not be taking: LHRH agonists, investigational agents

Disqualifiers: Second malignancy, Malabsorption, Heart failure, others

Compensation: Varies

Number of Visits: 5

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a broccoli extract supplement called BroccoMax® can affect the chemicals that feed prostate cancer. Participants will take either BroccoMax® or a placebo (a dummy treatment) to determine if the supplement makes a difference before their prostate surgery. This trial targets men diagnosed with prostate cancer who are scheduled for surgery. Participants should be in good health and able to take pills consistently. As an unphased trial, this study offers a unique opportunity to contribute to scientific understanding and potentially benefit from a novel approach to prostate cancer treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must avoid dietary sources of glucosinolates and isothiocyanates for 4 weeks. You also cannot take any other investigational agents, dietary supplements, or herbal supplements during the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that sulforaphane (SFN), the main ingredient in BroccoMax®, is generally safe for most people. Research indicates that products rich in sulforaphane have been used safely for up to six months, with most people not experiencing major side effects. Although specific safety data for BroccoMax® itself is lacking, its main ingredient, sulforaphane, is likely safe when used as directed. BroccoMax® is available over the counter, suggesting it is generally safe for everyday use. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about BroccoMax® for prostate cancer because it introduces a unique approach by using sulforaphane (SFN), a compound found naturally in broccoli. Unlike standard treatments like surgery, radiation, or hormone therapy, BroccoMax® leverages SFN’s potential anti-cancer properties to target cancer cells in a more natural way. This supplement offers a different mechanism of action by potentially interfering with cancer cell growth and survival, which could provide a complementary option to existing therapies.

What evidence suggests that BroccoMax® might be an effective treatment for prostate cancer?

Research has shown that sulforaphane (SFN), the main ingredient in BroccoMax®, might help slow prostate cancer. Earlier studies found that consuming large amounts of broccoli sprouts, which contain SFN, slowed prostate tumor growth and reduced cancer severity. Another study found that broccoli sprouts significantly lowered the risk of prostate cancer becoming more aggressive. Additionally, SFN has shown potential in treating prostate cancer that recurs after surgery. In this trial, participants will receive either BroccoMax®, which contains SFN, or a placebo. These findings suggest that SFN in BroccoMax® could help manage prostate cancer. ^{1 2 5 6 7}

Who Is on the Research Team?

Bruce Jacobs, MD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am willing to take a daily pill, which could be a placebo or BroccoMax®, for 4 weeks before my prostate surgery.

My overall health is good, and my liver and blood tests are within normal ranges.

Subjects willing to abstain from dietary sources of glucosinolates and isothiocyanates for the duration of the study

Exclusion Criteria

I have been treated with hormone therapy for my cancer.

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

I cannot have prostate surgery due to other health issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Treatment

Participants receive BroccoMax® or placebo for 4 weeks, with daily intake of tablets

4 weeks

2 visits (in-person)

End of Study Evaluation

Physical exam, blood and urine collection, adverse event assessment, and tumor sample collection

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with routine follow-up visits

6 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• BroccoMax®
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: BroccoMax® Experimental Treatment 1 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: Placebo Placebo Group 1 Intervention

Following randomization, subjects will begin to take four placebo tablets in the morning with breakfast and four tablets in the evening with dinner.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Vegetarian diets may lower the risk of prostate cancer, but the specific role of dietary fiber is unclear due to the antioxidant properties of plant foods.

A proposed nutritional approach, including a diet with low fat, high fiber, and 40 g of soybean protein daily, is being studied as a potential strategy for managing prostate cancer, although more rigorous large-scale studies are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cancer of the prostate: influence of nutritional factors. A new nutritional approach]. de la Taille, A., Katz, A., Vacherot, F., et al.[2017]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10138336/

Sulforaphane and Its Protective Role in Prostate Cancer At week 28, the group fed with 15% broccoli sprout diet showed a slower rate of prostate tumor development, decreased cancer severity and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6041877/

Broccoli Sprouts Delay Prostate Cancer Formation and ... Broccoli sprouts reduced prostate cancer incidence and progression to invasive cancer by 11- and 2.4-fold at 12 and 28 wk of age, respectively. There was a ...

3. withpower.com withpower.com/trial/phase-prostatic-neoplasms-4-2019-d9eb1

Broccoli Supplement for Prostate Cancer BroccoMax® is unique because it uses a broccoli supplement, which is a cruciferous vegetable, to potentially reduce the risk of prostate cancer progression.

4. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2023.1251895/full

Efficacy and tolerability of sulforaphane in the therapeutic ... This paper presents a systematic review aimed at assessing the therapeutic potential of sulforaphane (SFN) in the treatment of diverse cancer types.

5. aacrjournals.org aacrjournals.org/cancerpreventionresearch/article/8/8/712/50472/Effect-of-Sulforaphane-in-Men-with-Biochemical

Effect of Sulforaphane in Men with Biochemical Recurrence ... Daily administration of free sulforaphane shows promise in managing biochemical recurrences in prostate cancer after radical prostatectomy.

6. prevention.cancer.gov prevention.cancer.gov/clinical-trials/clinical-trials-search/nct03665922

Biomarkers of Sulforaphane/Broccoli Sprout Extract in ... This study will test whether oral intake of a dietary supplement called BroccoMax®, which is a special blend of broccoli extract containing a chemical ...

7. webmd.com webmd.com/vitamins/ai/ingredientmono-1070/sulforaphane

Sulforaphane - Uses, Side Effects, and More It is possibly safe when used as medicine. Sulforaphane and sulforaphane-rich broccoli extract products have been used safely for up to 6 months. It's usually ...