Study on White Button Mushroom Supplement for Reducing PSA Levels in Patients with Recurrent or Untreated Low-Risk Prostate Cancer

Sponsor: City of Hope Medical Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04519879

Provider View

This clinical trial is exploring whether a supplement made from white button mushrooms can help lower PSA levels in men with prostate cancer that has either returned after treatment or is low-risk and untreated. PSA is a marker in the blood that indicates prostate growth.

Patient Parameters

Program Overview

This study is investigating if taking a white button mushroom supplement can reduce PSA levels in men with prostate cancer that has come back or is low-risk and untreated. PSA is a blood marker that helps track prostate growth. The supplement may also affect the immune system and hormone levels related to prostate cancer growth.

Description

The study has two main goals:

  1. To see if the white button mushroom supplement can lower PSA levels in men with recurrent prostate cancer over 12 weeks and in men with untreated low-risk prostate cancer over 48 weeks.
  2. To monitor any side effects and how long it takes for PSA levels to rise again.

The study is divided into two groups:

  • Group 1 (Recurrent Prostate Cancer):

    • Arm 1A: Participants take the mushroom supplement twice daily for up to 36 weeks unless the cancer progresses or side effects become unacceptable.
    • Arm 1B: Participants are observed for 12 weeks. If PSA levels rise, they can choose to start the mushroom supplement.

  • Group 2 (Untreated Low-Risk Prostate Cancer):

    • Arm 2A: Participants take the mushroom supplement twice daily for up to 48 weeks unless the cancer progresses or side effects become unacceptable.
    • Arm 2B: Participants are monitored through active surveillance for 48 weeks.

After completing the study treatment, participants will have a follow-up visit after 30 days.

Eligibility Criteria

Inclusion Criteria

  • Must provide informed consent.
  • For untreated low-risk prostate cancer: Agree to have a prostate biopsy at the start and after 48 weeks.
  • Willing to avoid other mushroom supplements during the study.
  • Have a performance status score of 0 to 2, indicating good overall health.
  • Have a confirmed diagnosis of prostate adenocarcinoma.
  • For Recurrent Prostate Cancer (Group 1):
    • PSA levels must be rising after previous treatment.
    • Testosterone levels above 50 ng/dL.
    • May have had certain local treatments or up to 24 months of hormone therapy, completed more than 6 months ago.
    • No signs of cancer spread on recent scans.
  • For Untreated Low-Risk Prostate Cancer (Group 2):
    • Diagnosed within 12 months and choosing active surveillance.
    • Clinical stage T1c-T2a and Gleason score of 6 or 3+4.
    • No prior prostate cancer treatments.
  • Adequate blood counts and organ function as shown by recent tests.

Exclusion Criteria

  • Currently receiving other investigational cancer treatments or high-dose steroids.
  • Used mushroom supplements in the last 3 months.
  • For Recurrent Prostate Cancer (Group 1):
    • Hormone therapy lasting more than 24 months or within 6 months.
    • Recent chemotherapy or other prostate cancer treatments.
  • Known allergy to mushrooms.
  • Uncontrolled illness or active infection.
  • Heart failure or irregular heartbeat.
  • Other cancers within the last 2 years unless treated and in remission.
  • Any condition that might make participating unsafe or difficult.

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