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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

Primary Purpose

Prostate Adenocarcinoma, PSA Failure, PSA Progression

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Clinical Observation
Patient Observation
Questionnaire Administration
White Button Mushroom Extract
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • City of Hope Medical CenterRecruiting
  • City of Hope Rancho CucamongaRecruiting
  • John Wayne Cancer InstituteRecruiting
  • City of Hope South PasadenaRecruiting
  • City of Hope West CovinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Arm IA (white mushroom extract)

Arm IB (clinical observation)

Arm IIA (white mushroom extract)

Arm IIB (active surveillance)

Arm Description

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.

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.

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.

Patients undergo active surveillance for 48 weeks.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
September 12, 2019
Last Updated
July 24, 2023
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04519879
Brief Title
White Button Mushroom Sup for the Reduction of PSA in Pts With Biochemically Rec or Therapy Naive Fav Risk Prostate CA
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2021 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm IA (white mushroom extract)
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm IB (clinical observation)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Arm IIA (white mushroom extract)
Arm Type
Experimental
Arm Description
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 Title
Arm IIB (active surveillance)
Arm Type
Active Comparator
Arm Description
Patients undergo active surveillance for 48 weeks.
Intervention Type
Other
Intervention Name(s)
Clinical Observation
Other Intervention Name(s)
observation
Intervention Description
Undergo clinical observation
Intervention Type
Other
Intervention Name(s)
Patient Observation
Other Intervention Name(s)
Active Surveillance, deferred therapy, expectant management, observation, Watchful Waiting
Intervention Description
Undergo active surveillance
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Drug
Intervention Name(s)
White Button Mushroom Extract
Other Intervention Name(s)
WBM Extract
Intervention Description
Given PO
Primary Outcome Measure Information:
Title
Prostate-specific antigen (PSA) (ng/mL) levels (Cohort 1)
Description
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.
Time Frame
At 12 weeks
Title
Relative change in PSA (Cohort 2)
Description
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.
Time Frame
Baseline up to 48 weeks
Secondary Outcome Measure Information:
Title
Incidence of adverse events
Description
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.
Time Frame
Up to 48 weeks
Title
Proportion of patients with PSA response (Cohort 1)
Description
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.
Time Frame
Up to 48 weeks
Title
Time to PSA progression (Cohort 1)
Description
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.
Time Frame
Time from randomization to PSA progression, assessed up to 48 weeks
Title
Time to initiation of additional therapy (Cohort 2)
Description
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.
Time Frame
Baseline up to 48 weeks
Title
Time to progression (Cohort 2)
Description
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.
Time Frame
From randomization to progression, assessed up to 48 weeks
Other Pre-specified Outcome Measures:
Title
Change in temporal levels of circulating myeloid-derived suppressor cells (MDSCs)
Description
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).
Time Frame
Baseline to 48 weeks
Title
Change in temporal levels of pro-/anti-inflammatory mediators
Description
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.
Time Frame
Baseline up to 48 weeks
Title
Sexual function
Description
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.
Time Frame
Up to 48 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clayton S Lau
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clayton S. Lau
Phone
626-218-5733
Email
cllau@coh.org
First Name & Middle Initial & Last Name & Degree
Clayton S. Lau
Facility Name
City of Hope Rancho Cucamonga
City
Rancho Cucamonga
State/Province
California
ZIP/Postal Code
91730
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clayton S. Lau
Phone
626-218-5733
Email
cllau@coh.org
First Name & Middle Initial & Last Name & Degree
Clayton S. Lau
Facility Name
John Wayne Cancer Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Przemyslaw W. Twardowski
Phone
310-829-8317
Email
Przemyslaw.Tawdowski@providence.org
First Name & Middle Initial & Last Name & Degree
Przemyslaw W. Twardowski
Facility Name
City of Hope South Pasadena
City
South Pasadena
State/Province
California
ZIP/Postal Code
91030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clayton S. Lau
Phone
626-218-5733
Email
cllau@coh.org
First Name & Middle Initial & Last Name & Degree
Clayton S. Lau
Facility Name
City of Hope West Covina
City
West Covina
State/Province
California
ZIP/Postal Code
91790
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clayton S. Lau
Phone
626-218-5733
Email
cllau@coh.org
First Name & Middle Initial & Last Name & Degree
Clayton S. Lau

12. IPD Sharing Statement

Learn more about this trial

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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