Investigating the Effects of Mikei® Red Reishi Essence EX on the Immune System of Prostate Cancer Patients and Patients With Non-cancerous Conditions of the Prostate

Inclusion Criteria:

- Male age between 50-85

- Diagnosed with prostate cancer or high grade PIN within the last 24 months through the
most recent biopsy; or patients who have a total PSA level above 4.0 but have not been
diagnosed with prostate cancer yet

- Has not received any prostate cancer therapy including surgery, chemotherapy, hormone
therapy, or radiation therapy

- Clinical Gleason score of the tumor is ≤6 for patients ≤70 years or ≤7 for >70 years;
(non-applicable for non-cancer patients with elevated PSA)

- The clinical stage of the cancer is T1c or below (non-applicable for non-cancer
patients with elevated PSA)

- The patients have been recommended for and placed under active surveillance without
immediate treatment

- Able to provide written informed consent

Exclusion Criteria:

- Infants, children and teenagers

- Prisoners

- Patients who receive treatment with 5-alpha reductase inhibitors (finasteride
[Propecia®, Proscar®,], or dutasteride [Avodart®) within 28 days prior to
randomization are not eligible. The use of these drugs is not allowed during the
patients' study participation.

- Patients with a history of non-cutaneous malignancy in the previous 5 years are not
eligible.

- Patients taking warfarin, heparin, Aspirin >81mg/day, or other prescribed blood
thinners: Reishi may increase the risk of bleeding.

- Patients undergoing chemotherapy: Reishi may make some chemotherapy drugs less
effective.

- Patients taking immunosuppressants (Corticosteroids, Calcineurin inhibitors, mTOR
inhibitors, IMDH inhibitors, Biologics, Monoclonal antibodies): Reishi can stimulate
immune responses.

- Patients taking cytochrome P450 2E1, 1A2, and 3A sensitive substrate drugs: Reishi may
increase the risk of side effects of these drugs.

- Subject has clinically significant hepatic impairment