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

39 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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 the broccoli supplement safe for humans?

The available research does not provide specific safety data for broccoli supplements in humans, but similar dietary interventions, like those involving green tea and lycopene, were well tolerated in clinical trials. ^{1 2 3 4 5}

How does the BroccoMax® treatment for prostate cancer differ from other treatments?

BroccoMax® is unique because it uses a broccoli supplement, which is a cruciferous vegetable, to potentially reduce the risk of prostate cancer progression. This approach is based on studies suggesting that high intake of cruciferous vegetables may significantly decrease the risk of prostate cancer progression, offering a natural dietary strategy compared to traditional medical treatments. ^{2 3 4 6 7}

What data supports the effectiveness of the treatment BroccoMax® for prostate cancer?

Research suggests that eating cruciferous vegetables, like broccoli, which are rich in sulforaphane, may lower the risk of prostate cancer progression. This is because sulforaphane has properties that might help prevent cancer from getting worse. ^{2 8 9 10 11}

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. United States pubmed.ncbi.nlm.nih.gov

Vegetable and fruit intake after diagnosis and risk of prostate cancer progression. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Dietary trial in prostate cancer: Early experience and implications for clinical trial design. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Transcriptional changes in prostate of men on active surveillance after a 12-mo glucoraphanin-rich broccoli intervention-results from the Effect of Sulforaphane on prostate CAncer PrEvention (ESCAPE) randomized controlled trial. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Cruciferous vegetables, genetic polymorphisms in glutathione S-transferases M1 and T1, and prostate cancer risk. [2007]

5. United States pubmed.ncbi.nlm.nih.gov

Supplement use among men with prostate cancer. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Pharmacokinetics and pharmacodynamics of broccoli sprouts on the suppression of prostate cancer in transgenic adenocarcinoma of mouse prostate (TRAMP) mice: implication of induction of Nrf2, HO-1 and apoptosis and the suppression of Akt-dependent kinase pathway. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

ProDiet: A Phase II Randomized Placebo-controlled Trial of Green Tea Catechins and Lycopene in Men at Increased Risk of Prostate Cancer. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Food extracts consumed in Mediterranean countries and East Asia reduce protein concentrations of androgen receptor, phospho-protein kinase B, and phospho-cytosolic phospholipase A(2)alpha in human prostate cancer cells. [2023]

9. India pubmed.ncbi.nlm.nih.gov

Chemoprevention of prostate cancer: Natural compounds, antiandrogens, and antioxidants - In vivo evidence. [2021]

10. France pubmed.ncbi.nlm.nih.gov

[Cancer of the prostate: influence of nutritional factors. A new nutritional approach]. [2017]

11. United States pubmed.ncbi.nlm.nih.gov

Combinations of tomato and broccoli enhance antitumor activity in dunning r3327-h prostate adenocarcinomas. [2022]