White Button Mushroom Extract for Prostate Cancer

Not currently recruiting at 6 trial locations

Overseen By Clayton S. Lau

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: City of Hope Medical Center

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

Disqualifiers: Allergy to mushrooms, Uncontrolled illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 36 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a supplement made from white button mushrooms can lower PSA levels, a marker linked to prostate cancer, in men whose cancer has returned or who have not yet received treatment. Researchers aim to determine if this supplement also affects the immune system and hormones related to cancer growth. Participants will either take the mushroom supplement (white button mushroom extract) or be under observation, with some having the option to switch if needed. This trial suits men with prostate cancer who have experienced a rise in PSA after surgery or other therapies, or those newly diagnosed who have not started any treatment. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

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.

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

Research has shown that white button mushroom extract might be safe and could help lower PSA levels in prostate cancer patients. In earlier studies, about 36% of participants experienced a decrease in PSA levels after using the extract, suggesting effectiveness for some individuals.

Initial findings also indicated that patients tolerated the extract well, with no major safety issues reported. This is encouraging for those considering participation in a trial with this treatment. While these early studies suggest safety, more research is needed to fully confirm these results. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard of care for prostate cancer, which includes options like surgery, radiation, and hormone therapy, the white button mushroom extract offers a novel approach by utilizing a natural ingredient. Researchers are intrigued because this extract could potentially modulate the immune system and inhibit cancer growth through unique compounds found in mushrooms, such as polysaccharides. Additionally, the oral administration of the extract could provide a less invasive treatment option with potentially fewer side effects compared to conventional therapies. These features make it a promising candidate that could complement or offer an alternative to existing treatments.

What evidence suggests that white button mushroom extract might be an effective treatment for prostate cancer?

This trial will evaluate the effects of white button mushroom extract on prostate-specific antigen (PSA) levels in prostate cancer patients. Participants may receive the extract, which studies have shown can affect PSA levels, a marker used to monitor prostate cancer growth. Research suggests that this extract might slow or even stop the spread of prostate cancer. Some studies have found that it reduces the number of certain cells that help tumors grow. Overall, early findings suggest that white button mushrooms could be a promising treatment for prostate cancer by influencing PSA levels and the immune system. ^{1 2 4 6 7}

Who Is on the Research Team?

Clayton S. Lau

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Clinical Observation
• Patient Observation
• White Button Mushroom Extract

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.

How Is the Trial Designed?

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+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8542389/

White Button Mushroom (Agaricus bisporus) Disrupts ... White button mushroom (WBM) (Agaricus bisporus) is a potential prostate cancer (PCa) chemopreventative and therapeutic agent.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0955286320306124

White button mushroom (Agaricus bisporus) disrupts ... Our clinical phase І trial suggested that therapy with white button mushroom (WBM) impacted prostate-specific antigen (PSA) levels in prostate cancer patients.

3. news-medical.net news-medical.net/news/20241112/Study-uncovers-why-white-button-mushrooms-may-help-prevent-prostate-cancer-progression.aspx

Study uncovers why white button mushrooms may help ... Taking an investigational white button mushroom supplement shows promise in slowing and even preventing prostate cancer from spreading among men.

4. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.29421

A phase I trial of mushroom powder in patients with ... These results indicate that mushroom intake can modulate PSA levels in biochemically recurrent prostate cancer.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11467013/

Reduction of myeloid‐derived suppressor cells in prostate ... White button mushroom (WBM) treatment resulted in a reduction in pro‐tumoural MDSCs, notably polymorphonuclear MDSCs (PMN‐MDSCs), along with activation of anti‐ ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/19005974/

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

7. cancerletter.com cancerletter.com/clinical-roundup/20210507_8e/

City of Hope opens phase II clinical trial to test if intake ... ... white button mushroom extract is safe and potentially effective against prostate cancer. About 36% of study participants had some decline in ...