What drugs or interventions are being studied?

chemotherapy, immunotherapy, radiation, prednisone

Home › Trials › NCT04519879

Using white button mushroom supplements to lower PSA levels in prostate cancer patients

A Randomized Phase 2 Trial of White Button Mushroom Supplement in Patients With Biochemically Recurrent Prostate Cancer Following Local Therapy and in Therapy Na?ve Patients With Favorable Risk Prostate Cancer Undergoing Active Surveillance

Phase 2 Interventional City of Hope Medical Center · NCT04519879

This study is testing if white button mushroom supplements can help lower PSA levels in men with recurrent prostate cancer or those who haven't started treatment yet.

Quick facts

Phase	Phase 2
Study type	Interventional
Enrollment	132 (estimated)
Ages	18 Years and up
Sex	Male
Sponsor	City of Hope Medical Center Academic / other
Drugs / interventions	chemotherapy, immunotherapy, radiation, prednisone
Locations	7 sites (Duarte, California and 6 other locations)
Trial ID	NCT04519879 on ClinicalTrials.gov

What this trial studies

This phase II trial investigates the effectiveness of white button mushroom supplements in reducing prostate-specific antigen (PSA) levels in patients with recurrent prostate cancer or those who have not yet undergone therapy. The study is divided into two cohorts: one focusing on patients with biochemically recurrent prostate cancer and the other on therapy-naive patients with favorable risk. Participants will be monitored for PSA changes over 12 weeks and 48 weeks, alongside evaluations of immune response and potential side effects. The trial aims to provide insights into the immunomodulatory effects of the supplement and its impact on sexual function and cancer progression.

Who should consider this trial

Good fit: Ideal candidates include men with biochemically recurrent prostate cancer or therapy-naive patients with favorable risk characteristics.

Not a fit: Patients with advanced prostate cancer or those currently undergoing other treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a novel dietary intervention to help manage PSA levels in prostate cancer patients.

How similar studies have performed: While the use of dietary supplements in cancer treatment is an emerging field, this specific approach with white button mushrooms is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Show full inclusion / exclusion criteria

Inclusion Criteria:

* Documented informed consent of the participant and/or legally authorized representative
* For therapy naive favorable risk prostate cancer (cohort 2 only): agreement to undergo baseline and 48 week prostate biopsy
* Willing to forego non-study supplements containing mushroom for the duration of the study
* Eastern Cooperative Oncology Group (ECOG) =\< 2
* Histologically or cytologically confirmed history of adenocarcinoma of the prostate
* BIOCHEMICALLY RECURRENT PROSTATE CANCER COHORT (COHORT 1) ONLY: PSA failure defined as:

  * PSA of \>= 0.2 ng/mL that has increased above nadir following prostatectomy, OR
  * PSA increase of 2.0 ng/mL above post-therapy nadir if other primary local therapy was used instead of prostatectomy
  * NOTE: PSA value must be increasing based on 2 consecutive measurements taken at least 2 weeks apart
* BIOCHEMICALLY RECURRENT PROSTATE CANCER COHORT (COHORT 1) ONLY: Testosterone levels \> 50 ng/dL
* BIOCHEMICALLY RECURRENT PROSTATE CANCER COHORT (COHORT 1) ONLY: Received any number of primary local therapies, defined as:

  * Radical prostatectomy
  * External beam radiation therapy
  * Radioactive seed implantation
  * Cryotherapy
  * High-intensity focused ultrasound (HIFU)
* BIOCHEMICALLY RECURRENT PROSTATE CANCER COHORT (COHORT 1) ONLY: May have received up to 24 months of neoadjuvant/adjuvant androgen deprivation therapy in conjunction with primary local therapy. Androgen deprivation therapy must have been completed \> 6 months from day (D)1 of the study
* BIOCHEMICALLY RECURRENT PROSTATE CANCER COHORT (COHORT 1) ONLY: Neoadjuvant/adjuvant cytotoxic chemotherapy must have been completed \> 6 months from day (D)1 of the study
* BIOCHEMICALLY RECURRENT PROSTATE CANCER COHORT (COHORT 1) ONLY: No clinical or radiographic evidence of metastatic disease within 2 months prior to day 1 of protocol therapy. If metastatic disease is detected by positron emission tomography (PET) imaging only patients are eligible as long as no metastatic disease is noted on computed tomography (CT) scan (or magnetic resonance imaging \[MRI\]) and bone scan
* THERAPY NAIVE FAVORABLE RISK PROSTATE CANCER COHORT (COHORT 2) ONLY: Adenocarcinoma of the prostate diagnosed =\< 12 months of protocol screening and has elected active surveillance as preferred management plan OR already on active surveillance
* THERAPY NAIVE FAVORABLE RISK PROSTATE CANCER COHORT (COHORT 2) ONLY: Clinical stage T1c-T2a as defined below:

  * T1c: Tumor identified by needle biopsy found in one or both sides, but not palpable
  * T2a: Tumor involves one-half of one side or less
* THERAPY NAIVE FAVORABLE RISK PROSTATE CANCER COHORT (COHORT 2) ONLY: Gleason score =\< 6 (grade group 1) or Gleason 3+4 (grade group 2)
* THERAPY NAIVE FAVORABLE RISK PROSTATE CANCER COHORT (COHORT 2) ONLY: Adequate biopsy of at least 10 biopsy cores
* THERAPY NAIVE FAVORABLE RISK PROSTATE CANCER COHORT (COHORT 2) ONLY: No prior therapy for prostate cancer defined as:

  * Local therapy including surgery , radiation or focal therapy (cryoablation, HIFU, light)
  * Systemic therapy (hormonal, immunotherapy, targeted, chemotherapy). Subjects who have used 5-alpha reductase inhibitor (e.g. finasteride or dutasteride) \> 6 months prior to D1 of protocol therapy will be allowed
* Platelets \> 100,000 /mm\^3 (within 28 days prior to day 1 of protocol therapy)
* Hemoglobin \> 8 g/dL (within 28 days prior to day 1 of protocol therapy)
* Aspartate aminotransferase, alanine aminotransferase, \< 3 x upper limit of normal (ULN) (within 28 days prior to day 1 of protocol therapy)
* Total bilirubin \< 2 x ULN (within 28 days prior to day 1 of protocol therapy)
* Creatinine \< 2 x ULN (within 28 days prior to day 1 of protocol therapy)

Exclusion Criteria:

* Other concomitant investigational anti-cancer therapy/ vaccines/biologics, corticosteroids with \> 10 mg of prednisone equivalent dose
* Therapy with mushroom supplements within last 3 months of randomization
* BIOCHEMICALLY RECURRENT PROSTATE CANCER COHORT (COHORT 1) ONLY: Neoadjuvant/adjuvant androgen derivation therapy lasting \> 24 months or within 6 months prior to day 1 of protocol therapy
* BIOCHEMICALLY RECURRENT PROSTATE CANCER COHORT (COHORT 1) ONLY: Neoadjuvant/adjuvant chemotherapy within 6 months prior to day 1 of protocol therapy
* BIOCHEMICALLY RECURRENT PROSTATE CANCER COHORT (COHORT 1) ONLY: Prior therapy for recurrent prostate cancer (unless given as a component of attempted curative salvage treatment including salvage radiation therapy, and completed \> 6 months before day 1 of protocol therapy):

  * Chemotherapy
  * Androgen deprivation therapy
  * Immunotherapy
  * Targeted therapy
* Known history of allergic reaction to mushrooms
* Clinically significant uncontrolled illness
* Active infection requiring treatment
* Uncontrolled congestive heart failure, cardiac arrhythmia
* History of other primary non-skin malignancy within previous 2 years unless treated with curative intent and in remission
* Any other condition that would, in the Investigator?s judgment, contraindicate the patient?s participation in the clinical study due to safety concerns with clinical study procedures
* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Where this trial is running

Duarte, California and 6 other locations

City of Hope Medical Center — Duarte, California, United States (Recruiting)
City of Hope at Glendora — Glendora, California, United States (Recruiting)
City of Hope at Irvine Lennar — Irvine, California, United States (Recruiting)
City of Hope Rancho Cucamonga — Rancho Cucamonga, California, United States (Recruiting)
John Wayne Cancer Institute — Santa Monica, California, United States (Recruiting)
City of Hope South Pasadena — South Pasadena, California, United States (Suspended)
City of Hope West Covina — West Covina, California, United States (Recruiting)

Study contacts

Principal investigator: Clayton S Lau — City of Hope Medical Center

How to participate

Review the eligibility criteria above with your treating physician.
Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov → Find more trials like this →

Conditions Prostate Adenocarcinoma PSA Failure PSA Progression Recurrent Prostate Carcinoma Stage I Prostate Cancer AJCC v8 Stage IIA Prostate Cancer AJCC v8 Stage IIB Prostate Cancer AJCC v8 Stage IIC Prostate Cancer AJCC v8

Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.