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

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ClinicalTrials.gov Identifier: NCT04519879
Recruitment Status : Not yet recruiting
First Posted : August 20, 2020
Last Update Posted : September 7, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

Brief 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. 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.

Condition or disease Intervention/treatment Phase
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 Stage IIIA Prostate Cancer AJCC v8 Stage IIIC Prostate Cancer AJCC v8 Other: Clinical Observation Other: Patient Observation Other: Questionnaire Administration Drug: White Button Mushroom Extract Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. 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:

I. 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:

I. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : November 1, 2020
Estimated Primary Completion Date : July 19, 2021
Estimated Study Completion Date : July 19, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm IA (white mushroom extract)
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.
Other: Questionnaire Administration
Ancillary studies

Drug: White Button Mushroom Extract
Given PO
Other Name: WBM Extract

Active Comparator: Arm IB (clinical observation)
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.
Other: Clinical Observation
Undergo clinical observation
Other Name: observation

Other: Questionnaire Administration
Ancillary studies

Experimental: Arm IIA (white mushroom extract)
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.
Other: Questionnaire Administration
Ancillary studies

Drug: White Button Mushroom Extract
Given PO
Other Name: WBM Extract

Active Comparator: Arm IIB (active surveillance)
Patients undergo active surveillance for 48 weeks.
Other: Patient Observation
Undergo active surveillance
Other Names:
  • Active Surveillance
  • deferred therapy
  • expectant management
  • observation
  • Watchful Waiting

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Prostate-specific antigen (PSA) (ng/mL) levels (Cohort 1) [ Time Frame: At 12 weeks ]
    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.

  2. Relative change in PSA (Cohort 2) [ Time Frame: Baseline up to 48 weeks ]
    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.


Secondary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: Up to 48 weeks ]
    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.

  2. Proportion of patients with PSA response (Cohort 1) [ Time Frame: Up to 48 weeks ]
    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.

  3. Time to PSA progression (Cohort 1) [ Time Frame: Time from randomization to PSA progression, assessed up to 48 weeks ]
    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.

  4. Time to initiation of additional therapy (Cohort 2) [ Time Frame: Baseline up to 48 weeks ]
    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.

  5. Time to progression (Cohort 2) [ Time Frame: From randomization to progression, assessed up to 48 weeks ]
    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.


Other Outcome Measures:
  1. Change in temporal levels of circulating myeloid-derived suppressor cells (MDSCs) [ Time Frame: Baseline to 48 weeks ]
    Will be studies within the peripheral blood mononuclear cell (PBMC) compartment. Will evaluate the relative change in prostate cancer-associated MDSCs after 12 weeks of WBM supplement intake in borderline resectable pancreatic cancer patients versus in those on observation using a two group t-test. Results for cohort 1 will be confirmed by analyzing prostate cancer-associated MDSCs in cohort 2 as well (change from baseline to 48 weeks).

  2. Change in temporal levels of pro-/anti-inflammatory mediators [ Time Frame: Baseline up to 48 weeks ]
    Will include cytokines/growth factors/chemokines, including IL-15 in plasma. Will evaluate the baseline correlatives and the relative role of treatment in a multivariate exploratory analysis.

  3. Sexual function [ Time Frame: Up to 48 weeks ]
    Will be evaluated by the sexual function questionnaire, including the Sexual Health Inventory for Men score. The Sexual Health Inventory for Men (SHIM) Questionnaire scoring system will be used.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04519879


Locations
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United States, California
City of Hope Medical Center
Duarte, California, United States, 91010
Contact: Clayton S. Lau    626-218-5733    cllau@coh.org   
Principal Investigator: Clayton S. Lau         
City of Hope Rancho Cucamonga
Rancho Cucamonga, California, United States, 91730
Contact: Clayton S. Lau    626-218-5733    cllau@coh.org   
Principal Investigator: Clayton S. Lau         
John Wayne Cancer Institute
Santa Monica, California, United States, 90404
Contact: Przemyslaw W. Twardowski    310-582-7137    TwardowskiP@jwci.org   
Principal Investigator: Przemyslaw W. Twardowski         
City of Hope South Pasadena
South Pasadena, California, United States, 91030
Contact: Clayton S. Lau    626-218-5733    cllau@coh.org   
Principal Investigator: Clayton S. Lau         
City of Hope West Covina
West Covina, California, United States, 91790
Contact: Clayton S. Lau    626-218-5733    cllau@coh.org   
Principal Investigator: Clayton S. Lau         
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Clayton S Lau City of Hope Medical Center
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Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT04519879    
Other Study ID Numbers: 19296
NCI-2019-05587 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
19296 ( Other Identifier: City of Hope Medical Center )
P30CA033572 ( U.S. NIH Grant/Contract )
First Posted: August 20, 2020    Key Record Dates
Last Update Posted: September 7, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases