This phase II trial studies how well white button mushroom supplement works in reducing prostate-specific antigen (PSA) levels in patients with prostate cancer that has come back (recurrent) or has favorable risk and has not undergone any therapy (therapy naive). PSA is a blood marker of prostate growth. White button mushroom supplement may affect PSA level, various parameters of immune system and levels of hormones that may have a role in prostate cancer growth.
PRIMARY OBJECTIVES: I. To assess the proportion of patients with any prostate specific antigen (PSA) reduction at 12 weeks (\~3 months) in observation + white button mushroom (WBM) supplement arm and observation only arm (control arm). (Cohort 1) II. To assess relative change in PSA at 48 weeks (\~12 months) from baseline with or without WBM treatment. (Cohort 2) SECONDARY OBJECTIVES: I. To evaluate, adverse events, PSA-response rate and time to PSA progression. (Cohort 1) II. To evaluate adverse events, time to initiation of additional therapy and progression. (Cohort 2) EXPLORATORY OBJECTIVES: I. To characterize the immunomodulatory effects of WBM supplement in serial blood samples. (Cohort 1) II. To assess the effect of therapy with WBM on sexual function. (Cohort 1) III. To assess the effect of WBM on Gleason grade in prostate cancer subjects on active surveillance. (Cohort 2) IV. To characterize the immunomodulatory effects of WBM supplement in serial blood samples and in tumor tissue. (Cohort 2) V. To characterize changes in cancer signaling pathways in tumor tissue after intake of WBM supplement. (Cohort 2) VI. To assess the effect of WBM supplement on sexual function. (Cohort 2) OUTLINE: Patients are assigned to 1 of 2 cohorts. COHORT I: Biochemically recurrent prostate cancer patients are randomized to 1 of 2 arms. ARM IA: Patients receive white button mushroom extract orally (PO) twice daily (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. ARM IB: 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. COHORT II: Therapy naive favorable risk prostate cancer patients are randomized to 1 of 2 arms. ARM IIA: 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. ARM IIB: Patients undergo active surveillance for 48 weeks. After completion of study treatment, patients are followed up at 30 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
133
Undergo clinical observation
Undergo active surveillance
Ancillary studies
Given PO
City of Hope Medical Center
Duarte, California, United States
City of Hope at Glendora
Glendora, California, United States
City of Hope at Irvine Lennar
Irvine, California, United States
City of Hope Rancho Cucamonga
Rancho Cucamonga, California, United States
John Wayne Cancer Institute
Santa Monica, California, United States
City of Hope South Pasadena
South Pasadena, California, United States
City of Hope West Covina
West Covina, California, United States
Prostate-specific antigen (PSA) (ng/mL) levels (Cohort 1)
For continuous variables, descriptive statistics (number \[n\], mean, standard deviation, standard error, median range) will be provided. For categorical variables, patient counts and percentages will be provided.
Time frame: At 12 weeks
Relative change in PSA (Cohort 2)
The relative difference in PSA will be measured as log (48 week PSA/baseline PSA). Undetectable PSA at 48 weeks will be coded as the low end of the lab measurement range for PSA. This measure of relative difference will be compared between the white button supplement (WBM) + active surveillance and active surveillance only patients. For continuous variables, descriptive statistics (n, mean, standard deviation, standard error, median range) will be provided. For categorical variables, patient counts and percentages will be provided.
Time frame: Baseline up to 48 weeks
Incidence of adverse events
Will be defined per National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Grade 2 serious adverse events and all grade 3-5 adverse events will be reported in the e-case report forms. Observed toxicities will be summarized in terms of type (organ affected or laboratory determination), severity, attribution, time of onset, probable association with the study treatment and reversibility or outcome.
Time frame: Up to 48 weeks
Proportion of patients with PSA response (Cohort 1)
Will be defined as the sum of complete (PSA-normalization) and partial responders (PSA-partial response) vs non-responders. For continuous variables, descriptive statistics (number \[n\], mean, standard deviation, standard error, median range) will be provided. For categorical variables, patient counts and percentages will be provided.
Time frame: Up to 48 weeks
Time to PSA progression (Cohort 1)
For continuous variables, descriptive statistics (number \[n\], mean, standard deviation, standard error, median range) will be provided. For categorical variables, patient counts and percentages will be provided.
Time frame: Time from randomization to PSA progression, assessed up to 48 weeks
Time to initiation of additional therapy (Cohort 2)
For continuous variables, descriptive statistics (n, mean, standard deviation, standard error, median range) will be provided. For categorical variables, patient counts and percentages will be provided.
Time frame: Baseline up to 48 weeks
Time to progression (Cohort 2)
Will be defined as any Gleason grade 4 or 5 upon repeat biopsy or conversion from 3+4 to 4+3 or higher, prostate cancer is found in a greater number of prostate biopsy cores, prostate cancer occupies a greater extent of the prostate biopsy cores, PSA \> 100 ng/mL. For continuous variables, descriptive statistics (n, mean, standard deviation, standard error, median range) will be provided. For categorical variables, patient counts and percentages will be provided.
Time frame: From randomization to progression, assessed up to 48 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.