White Button Mushroom Extract for Prostate Cancer

Recruiting at5 trial locations

Overseen by Clayton S. Lau

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: City of Hope Medical Center

Must not be taking: Corticosteroids, Chemotherapy, Immunotherapy, others

Disqualifiers: Allergy to mushrooms, Uncontrolled illness, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial studies if a white button mushroom supplement can lower PSA levels in patients with recurrent or newly diagnosed prostate cancer. The supplement may also impact the immune system and hormone levels. White button mushrooms (Agaricus bisporus) have been studied for their potential effects on prostate-specific antigen (PSA) levels in prostate cancer patients.

Do I need to stop taking my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but you must avoid any supplements containing mushrooms during the study.

What data supports the effectiveness of the treatment White Button Mushroom Extract for prostate cancer?

Research shows that White Button Mushroom Extract can lower prostate-specific antigen (PSA) levels, which are often elevated in prostate cancer. It also disrupts cancer cell growth and promotes cancer cell death, suggesting it may help in treating prostate cancer. ^{1 2 3 4 5}

Is white button mushroom extract safe for humans?

Research on white button mushroom extract in prostate cancer patients suggests it is generally well-tolerated, with studies focusing on its effects on prostate-specific antigen levels and tumor growth. While specific safety data is limited, the extract is derived from a commonly consumed food, indicating a likely safe profile. ^{1 2 3 4 6}

How does the white button mushroom extract treatment differ from other prostate cancer treatments?

White button mushroom extract is unique because it disrupts androgen receptor signaling, which is crucial for prostate cancer growth, and reduces prostate-specific antigen (PSA) levels, potentially slowing cancer progression. This natural treatment offers a novel approach compared to traditional therapies by using a dietary component with anticancer properties. ^{1 2 3 4 6}

Research Team

Clayton S. Lau

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

Men with recurrent prostate cancer or those who are therapy naive with favorable risk can join this trial. They must have had a radical prostatectomy or radiation, no mushroom supplements recently, and agree to avoid them during the study. Key blood levels like PSA, testosterone, platelets, and hemoglobin need to be within certain ranges.

Inclusion Criteria

Aspartate aminotransferase, alanine aminotransferase, < 3 x upper limit of normal (ULN) (within 28 days prior to day 1 of protocol therapy)

I have had surgery to remove my prostate gland.

Documented informed consent of the participant and/or legally authorized representative

Exclusion Criteria

I am not on any other cancer treatments or taking more than 10 mg of steroids.

I have not taken mushroom supplements in the last 3 months.

I had cancer other than skin cancer in the last 2 years but am now in remission.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive white button mushroom extract orally twice daily. Treatment repeats every 4 weeks for cycles 1-3 then every 12 weeks for cycles 4-6 (36 weeks) in the absence of disease progression or unacceptable toxicity.

36 weeks

Observation

Patients undergo clinical observation for 12 weeks. If PSA continues to increase, patients have the option to receive the white button mushroom extract.

12 weeks

Active Surveillance

Therapy naive favorable risk prostate cancer patients undergo active surveillance for 48 weeks.

48 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment completion.

4 weeks

Treatment Details

Interventions

• Clinical Observation (Other)
• Patient Observation (Other)
• White Button Mushroom Extract (Other)

Trial Overview The trial is testing if white button mushroom extract can lower PSA levels in men with prostate cancer that's returned or hasn't been treated yet. It looks at how the supplement might affect immune system parameters and hormone levels related to cancer growth.

Participant Groups

Group I: Arm IIA (white mushroom extract) Experimental Treatment 2 Interventions

Patients receive white mushroom extract PO BID on day 1. Treatment repeats every 12 weeks for 4 cycles (48 weeks) in the absence of disease progression or unacceptable toxicity.

Group II: Arm IA (white mushroom extract) Experimental Treatment 2 Interventions

Patients receive white button mushroom extract PO BID on day 1. Treatment repeats every 4 weeks for cycles 1-3 then every 12 weeks for cycles 4-6 (36 weeks) in the absence of disease progression or unacceptable toxicity.

Group III: Arm IB (clinical observation) Active Control 2 Interventions

Patients undergo clinical observation for 12 weeks. If PSA continues to increase, patients have the option to receive the white button mushroom extract as in arm IA.

Group IV: Arm IIB (active surveillance) Active Control 2 Interventions

Patients undergo active surveillance for 48 weeks.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

Robert Stone

City of Hope Medical Center

Chief Executive Officer since 2014

Juris Doctorate from the University of Chicago, Bachelor's degree in Political Science from the University of Redlands

Sumanta (Monty) Pal

City of Hope Medical Center

Chief Medical Officer since 2023

MD

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Findings from Research

In a clinical phase I trial, white button mushroom (WBM) powder significantly reduced prostate-specific antigen (PSA) levels in patients with biochemically recurrent prostate cancer, suggesting its potential as a chemo-preventative and therapeutic agent.

WBM extract was shown to inhibit DHT-induced PSA expression and cell proliferation in prostate cancer cell lines, and it also suppressed tumor growth in patient-derived xenografts, indicating its mechanism of action involves disrupting androgen receptor signaling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

White button mushroom (Agaricus bisporus) disrupts androgen receptor signaling in human prostate cancer cells and patient-derived xenograft. Wang, X., Ha, D., Mori, H., et al.[2022]

In a study involving 36 patients with rising PSA levels due to biochemically recurrent prostate cancer, white button mushroom (WBM) powder was found to be safe, with no dose-limiting toxicities reported.

WBM treatment led to a notable PSA response rate of 11%, with two patients achieving complete response (CR) and two achieving partial response (PR), suggesting that WBM may effectively lower PSA levels and reduce immunosuppressive factors in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase I trial of mushroom powder in patients with biochemically recurrent prostate cancer: Roles of cytokines and myeloid-derived suppressor cells for Agaricus bisporus-induced prostate-specific antigen responses. Twardowski, P., Kanaya, N., Frankel, P., et al.[2021]

White button mushroom extract and its component, conjugated linoleic acid (CLA), effectively inhibited the growth of prostate cancer cells in vitro and reduced tumor size in mice, demonstrating their potential as anticancer agents.

The study revealed that mushroom extract not only induced apoptosis in cancer cells but also significantly altered gene expression related to cell death, growth, and metabolism, suggesting a complex mechanism of action that supports its use in cancer prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

White button mushroom (Agaricus bisporus) exhibits antiproliferative and proapoptotic properties and inhibits prostate tumor growth in athymic mice. Adams, LS., Phung, S., Wu, X., et al.[2013]

In a study involving 51 patients with non-metastasized prostate cancer, the two types of medical mushrooms (Senseiro and Rokkaku Reishi) did not show significant anticancer effects, as no patients experienced a partial response in terms of PSA reduction.

The study found that while there were no serious adverse effects from the mushroom supplements, they did not alter PSA doubling time or correlate with testosterone levels, indicating a lack of efficacy in disease progression management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical mushrooms used for biochemical failure after radical treatment for prostate cancer: an open-label study. Yoshimura, K., Kamoto, T., Ogawa, O., et al.[2010]

Agaricus blazei Murill (A. blazei) broth significantly inhibited the growth of both androgen-dependent and androgen-independent prostate cancer cells in vitro and in vivo, suggesting its potential as a therapeutic agent.

In a study with severe combined immunodeficient mice, oral supplementation of A. blazei broth suppressed tumor growth without adverse effects, indicating its safety and efficacy through mechanisms like inducing apoptosis and reducing tumor blood vessel formation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inhibitory mechanisms of Agaricus blazei Murill on the growth of prostate cancer in vitro and in vivo. Yu, CH., Kan, SF., Shu, CH., et al.[2014]

The white button mushroom extract significantly improved antioxidant enzyme activity and reduced tumor biomarkers in rats with DMBA-induced breast cancer, suggesting its protective effects against cancer.

Rats treated with the mushroom extract showed better maintenance of red blood cell levels and improved lipid profiles compared to those treated with doxorubicin, indicating its potential as a safer alternative in cancer prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the therapeutic potential of white button mushroom (Agaricus bisporus) against DMBA-induced breast cancer in Sprague Dawley rats. Latif, A., Issa Khan, M., Rakha, A., et al.[2022]

References

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

White button mushroom (Agaricus bisporus) disrupts androgen receptor signaling in human prostate cancer cells and patient-derived xenograft. [2022]

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

A phase I trial of mushroom powder in patients with biochemically recurrent prostate cancer: Roles of cytokines and myeloid-derived suppressor cells for Agaricus bisporus-induced prostate-specific antigen responses. [2021]

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

White button mushroom (Agaricus bisporus) exhibits antiproliferative and proapoptotic properties and inhibits prostate tumor growth in athymic mice. [2013]

4. Australia pubmed.ncbi.nlm.nih.gov

Medical mushrooms used for biochemical failure after radical treatment for prostate cancer: an open-label study. [2010]

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

Inhibitory mechanisms of Agaricus blazei Murill on the growth of prostate cancer in vitro and in vivo. [2014]

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

Evaluating the therapeutic potential of white button mushroom (Agaricus bisporus) against DMBA-induced breast cancer in Sprague Dawley rats. [2022]