← Back to Search

Other

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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 weeks
Awards & highlights

Study Summary

This trial studies the effects of white button mushroom supplement on PSA levels in men with recurrent or therapy-naive prostate cancer.

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.Check my eligibility
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.See study design
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
Select...
I have had surgery to remove my prostate gland.
Select...
My prostate cancer is early stage with a low Gleason score.
Select...
I am receiving or have received external beam radiation therapy.
Select...
I can take care of myself and am up and about more than 50% of my waking hours.
Select...
I have prostate cancer and have undergone treatments like surgery or radiation.
Select...
My prostate cancer diagnosis was confirmed through a tissue test.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Prostate-specific antigen (PSA) (ng/mL) levels (Cohort 1)
Relative change in PSA (Cohort 2)
Secondary outcome measures
Incidence of adverse events
Proportion of patients with PSA response (Cohort 1)
Time to PSA progression (Cohort 1)
+2 more
Other outcome measures
Change in temporal levels of circulating myeloid-derived suppressor cells (MDSCs)
Change in temporal levels of pro-/anti-inflammatory mediators
Sexual function

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.

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,328 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,158 Total Patients Enrolled
Clayton S LauPrincipal InvestigatorCity of Hope Medical Center

Media Library

Clinical Observation (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04519879 — Phase 2
Prostate Adenocarcinoma Research Study Groups: Arm IIA (white mushroom extract), Arm IB (clinical observation), Arm IIB (active surveillance), Arm IA (white mushroom extract)
Prostate Adenocarcinoma Clinical Trial 2023: Clinical Observation Highlights & Side Effects. Trial Name: NCT04519879 — Phase 2
Clinical Observation (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04519879 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the objectives of this research?

"The aim of this trial is to observe the Prostate-specific antigen (PSA) levels in patients over the course of 48 weeks. The success of the trial will be measured by the Proportion of patients with PSA response, which will be defined as the number of complete or partial responders 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."

Answered by AI

Has the White Button Mushroom Extract been given the green light by the FDA?

"Since this is a Phase 2 clinical trial, meaning that while there are safety data, there are no efficacy data, our team at Power estimates the safety of White Button Mushroom Extract to be a 2."

Answered by AI

Does this trial have a lot of facilities participating in the United States?

"At the moment, this trial is being conducted at 5 different sites. They are situated in Duarte, Rancho Cucamonga and West Covina as well as 2 other locations. If you decide to enroll, try to pick a location close to minimize travel."

Answered by AI

If a patient meets the qualifications, can they enroll in this clinical trial right now?

"That is accurate. The information available on clinicaltrials.gov affirms that this study, which was initially posted on May 10th 2021, is presently enrolling patients. There are 5 recruitement sites and the goal is to have 132 people enrolled in total."

Answered by AI

Who else is applying?

What state do they live in?
Wisconsin
How old are they?
65+
What site did they apply to?
City of Hope Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
White Button Mushroom Sup for the Reduction of PSA in Pts With Biochemically Rec or Therapy Naive Fav Risk Prostate CA
2021. "White Button Mushroom Sup for the Reduction of PSA in Pts With Biochemically Rec or Therapy Naive Fav Risk Prostate CA". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04519879.
All > Mens Health > Recurrent Prostate Cancer
~0 spots leftby Apr 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top