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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)
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
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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.

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
570 Previous Clinical Trials
1,922,484 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,232 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
~33 spots leftby May 2025
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