Dietary administration of mushroom mycelium extracts in patients with early stage prostate cancers managed expectantly: a phase II study.
OBJECTIVE
To assess the efficacy and safety of dietary supplements in patients with early stage prostate cancers who are managed expectantly.


METHODS
Seventy-four patients with early prostate cancer, who were treated with expectant management, enrolled in the study. A mushroom mycelium extract was given at a dose of 4.5 g/day for 6 months. The primary endpoint was the proportion of patients in which the prostate specific antigen level decreased by 50% or more following treatment. The adverse events, change of prostate specific antigen value and quality of life were also evaluated.


RESULTS
In only one of 74 patients (1.4%), the prostate specific antigen value decreased more than 50%. Grade 2 diarrhea and grade 1 itching were observed in one patient, and patient ingestion compliance was maintained near 100%. The alternation of prostate specific antigen values was stable before and after treatment. In subjects with strong anxiety prior to supplement ingestion, these feelings were significantly alleviated (state anxiety, P = 0.0018; trait anxiety, P = 0.0099).


CONCLUSIONS
In this phase II study of early prostate cancer patients who were managed expectantly, a mushroom mycelium extract was an ineffective treatment for reducing 50% or more the patient prostate specific antigen values.
Sumiyoshi
Yoshiteru
Y
Department of Urology, Shikoku Cancer Center, Ko-16, Minamiumemoto, Mastuyama, Ehime 791-0280, Japan. yosumisama@gmail.com
Hashine
Katsuyoshi
K
Kakehi
Yoshiyuki
Y
Yoshimura
Koji
K
Satou
Takehumi
T
Kuruma
Hidetoshi
H
Namiki
Syunichi
S
Shinohara
Nobuo
N
D000363:Agaricales / Q000737:chemistry*; D000368:Aged; D000369:Aged, 80 and over; D003967:Diarrhea / Q000139:chemically induced; D019587:Dietary Supplements; D006801:Humans; D008297:Male; D008875:Middle Aged; D025282:Mycelium / Q000737:chemistry*; D009367:Neoplasm Staging; D011134:Polysaccharides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D017430:Prostate-Specific Antigen / Q000032:analysis; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D011788:Quality of Life; D013997:Time Factors; D016896:Treatment Outcome
D011134:Polysaccharides; D017430:Prostate-Specific Antigen; C499366:Active Hexose Correlated Compound