What side effects are associated with this type of intervention?

Common treatments for Prostate Adenocarcinoma that affect PSA levels, immune parameters, and hormone levels include saw palmetto, soy products, and other complementary therapies. Saw palmetto has been associated with infrequent, mild side effects such as headache, nausea, and dizziness, with adverse effects generally comparable to placebo. Soy products have shown potential benefits in PSA kinetics but have not demonstrated significant adverse events. Other complementary therapies like modified citrus pectin and PC-SPES have shown some promise in affecting PSA levels and immune parameters, but PC-SPES was recalled due to toxicity concerns. Overall, these treatments are generally well-tolerated with mild side effects, but more extensive studies are needed to confirm their efficacy and safety.

What prior FDA approvals exist?

The FDA has approved several treatments for Prostate Adenocarcinoma that target PSA levels, immune parameters, and hormone levels. Abiraterone acetate, often combined with prednisone, is approved for its ability to lower PSA levels and inhibit androgen production, which is crucial for prostate cancer growth. Enzalutamide, an androgen receptor inhibitor, also reduces PSA levels and impacts hormone signaling. Immunotherapy agents like Sipuleucel-T have been approved to enhance the immune system's response against prostate cancer cells. These treatments collectively aim to manage prostate cancer by modulating hormonal pathways and enhancing immune activity, similar to the investigational effects of the White Button Mushroom Supplement.

What other types of research exist?

<ol> <li>Saw Palmetto (Serenoa repens): Studies have shown that saw palmetto can inhibit 5-alpha reductase, potentially reducing PSA levels and improving urinary symptoms in benign prostatic hyperplasia, which may be beneficial for prostate adenocarcinoma patients.</li> </ol> However, there are reports of adverse effects such as pancreatitis and intraoperative hemorrhage. 2. Ganoderol B (from Ganoderma lucidum): This compound has demonstrated anti-androgen effects, potentially useful in controlling prostate cancer by suppressing androgen receptor function and reducing PSA levels. 3. Plumbagin: Found in the roots of the plant Plumbago zeylanica, plumbagin has shown potential in inhibiting prostate cancer development by targeting specific proteins and markers involved in tumor growth. 4. Coprinus comatus: This mushroom strain has shown antiandrogenic activity, reducing AR and PSA transcript levels, and inhibiting prostate cell proliferation. 5. PC-SPES: Although no longer commercially available due to safety concerns, this herbal mixture had shown potent estrogenic activity and significant effects on PSA levels and tumor markers in prostate cancer patients.

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White Button Mushroom Extract for Prostate Cancer

Phase 2

Recruiting

Led By Clayton S Lau

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Radical prostatectomy

THERAPY NAIVE FAVORABLE RISK PROSTATE CANCER COHORT (COHORT 2) ONLY: Gleason score =< 6 (grade group 1) or Gleason 3+4 (grade group 2)

Must not have

Other concomitant investigational anti-cancer therapy/ vaccines/biologics, corticosteroids with > 10 mg of prednisone equivalent dose

Clinically significant uncontrolled illness

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 48 weeks

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects of white button mushroom extract aren't detailed here, potential risks may include allergic reactions for those sensitive to mushrooms and general digestive discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had surgery to remove my prostate gland.

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My prostate cancer is early stage with a low Gleason score.

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I am receiving or have received external beam radiation therapy.

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I can take care of myself and am up and about more than 50% of my waking hours.

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I have prostate cancer and have undergone treatments like surgery or radiation.

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My prostate cancer diagnosis was confirmed through a tissue test.

Exclusion Criteria

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

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

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I do not have any uncontrolled serious illnesses.

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I am currently being treated for an infection.

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I do not have uncontrolled heart failure or irregular heartbeats.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 48 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 48 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Prostate-specific antigen (PSA) (ng/mL) levels (Cohort 1)

Relative change in PSA (Cohort 2)

Secondary study objectives

Incidence of adverse events

Proportion of patients with PSA response (Cohort 1)

Time to PSA progression (Cohort 1)

+2 more

Other study objectives

Change in temporal levels of circulating myeloid-derived suppressor cells (MDSCs)

Change in temporal levels of pro-/anti-inflammatory mediators

Sexual function

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Arm IIA (white mushroom extract)Experimental Treatment2 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 Treatment2 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 Control2 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 Control2 Interventions

Patients undergo active surveillance for 48 weeks.

0 / 10Eligibility 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

Common treatments for Prostate Adenocarcinoma often target androgen signaling, as androgens play a crucial role in prostate cancer progression. Androgen deprivation therapy (ADT) reduces androgen levels or blocks their effects, leading to decreased prostate-specific antigen (PSA) levels and tumor growth inhibition. Antiandrogens, such as enzalutamide, further inhibit androgen receptor signaling. Natural compounds like the White Button Mushroom Supplement may reduce PSA levels, modulate immune responses, and affect hormone levels, potentially offering a complementary approach to traditional therapies. These mechanisms are vital for patients as they provide multiple avenues to control cancer progression and improve outcomes.

Brazilian Berry Extract Differentially Induces Inflammatory and Immune Responses in Androgen Dependent and Independent Prostate Cancer Cells.The culinary-medicinal mushroom Coprinus comatus as a natural antiandrogenic modulator.Soy isoflavones in the treatment of prostate cancer.