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Prostate AdenocarcinomaPhase 2NCT04519879

White Button Mushroom Sup for the Reduction of PSA in Pts With Biochemically Rec or Therapy Naive Fav Risk Prostate CA

A Phase 2 study testing Clinical Observation, Patient Observation and Questionnaire Administration in people with Prostate Adenocarcinoma and PSA Failure, run by City of Hope Medical Center at 7 sites in United States.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Clinical Observation, Patient Observation and Questionnaire Administration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
133 participants
Where
7 sitesUnited States
Study dates
10 May 2021to 14 May 2027
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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)

Who cannot join

  • 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
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  • 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)

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • City of Hope Medical Center

    Duarte, California, 91010

  • City of Hope at Glendora

    Glendora, California, 91741

  • City of Hope at Irvine Lennar

    Irvine, California, 92618

  • City of Hope Rancho Cucamonga

    Rancho Cucamonga, California, 91730

  • John Wayne Cancer Institute

    Santa Monica, California, 90404

  • City of Hope South Pasadena

    South Pasadena, California, 91030

  • City of Hope West Covina

    West Covina, California, 91790

Other trials in United States

About this study

Official title: 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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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:

  1. 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.

Being tested
Clinical Observation, Patient Observation, Questionnaire Administration, White Button Mushroom Extract
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Clinical ObservationOther

    Also called observation

    Undergo clinical observation

  • Patient ObservationOther

    Also called Active Surveillance, deferred therapy, expectant management, observation

    Undergo active surveillance

  • Questionnaire AdministrationOther

    Ancillary studies

  • White Button Mushroom ExtractDrug

    Also called WBM Extract

    Given PO

Study groups in NCT04519879
Study groupRoleWhat they receive
Arm IA (white mushroom extract)ExperimentalPatients 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.
Receives: Other: Questionnaire Administration; Drug: White Button Mushroom Extract
Arm IB (clinical observation)Active comparatorPatients 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.
Receives: Other: Clinical Observation; Other: Questionnaire Administration
Arm IIA (white mushroom extract)ExperimentalPatients 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.
Receives: Other: Questionnaire Administration; Drug: White Button Mushroom Extract
Arm IIB (active surveillance)Active comparatorPatients undergo active surveillance for 48 weeks.
Receives: Other: Patient Observation; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At 12 weeks

  2. 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.

    Measured: Baseline up to 48 weeks

Secondary outcomes (5)

  1. 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.

    Measured: Up to 48 weeks

  2. 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.

    Measured: Up to 48 weeks

  3. 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.

    Measured: Time from randomization to PSA progression, assessed up to 48 weeks

  4. 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.

    Measured: Baseline up to 48 weeks

  5. 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.

    Measured: From randomization to progression, assessed up to 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2020
  2. Study start10 May 2021
  3. Primary completion31 Mar 2026
  4. Study completion14 May 2027 (estimated)

Why it stopped: 05/26/2026 DSMC: Delinquent PMT reporting.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
133 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04519879
Sponsor's protocol ID
19296
Other IDs
NCI-2019-05587, 19296, P30CA033572
Status last verified
Nov 2026
First submitted
12 Sep 2019
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Wang X, Ma S, Twardowski P, Lau C, Chan YS, Wong K, Xiao S, Wang J, Wu X, Frankel P, Wilson TG, Synold TW, Presant C, Dorff T, Yu J, Sadava D, Chen S. Reduction of myeloid-derived suppressor cells in prostate cancer murine models and patients following white button mushroom treatment. Clin Transl Med. 2024 Oct;14(10):e70048. doi: 10.1002/ctm2.70048.

    PubMed 39390760

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Clinical Observation, Patient Observation and Questionnaire Administration in people with Prostate Adenocarcinoma and PSA Failure, run by City of Hope Medical Center at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 33 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prostate-specific antigen (PSA) (ng/mL) levels (Cohort 1) (time frame: At 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04519879, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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