Clinical Trial: NCT04519879 - My Cancer Genome

NCT04519879

Description:

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.

Related Conditions:

Prostate Adenocarcinoma

Recruiting Status:

Recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT04519879

Trial Eligibility

Document

Title

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

Clinical Trial IDs

ORG STUDY ID: 19296
SECONDARY ID: NCI-2019-05587
SECONDARY ID: 19296
SECONDARY ID: P30CA033572
NCT ID: NCT04519879

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
Stage IIIA Prostate Cancer AJCC v8
Stage IIIC Prostate Cancer AJCC v8

Interventions

Drug	Synonyms	Arms
White Button Mushroom Extract	WBM Extract	Arm IA (white mushroom extract)

Purpose

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.

Trial Arms

Name	Type	Description	Interventions
Arm IA (white mushroom extract)	Experimental	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.	White Button Mushroom Extract
Arm IB (clinical observation)	Active Comparator	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 IIA (white mushroom extract)	Experimental	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.	White Button Mushroom Extract
Arm IIB (active surveillance)	Active Comparator	Patients undergo active surveillance for 48 weeks.

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)

Maximum Eligible Age:	N/A
Minimum Eligible Age:	18 Years
Eligible Gender:	Male
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	Prostate-specific antigen (PSA) (ng/mL) levels (Cohort 1)
Time Frame:	At 12 weeks
Safety Issue:
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.

Secondary Outcome Measures

Measure:	Incidence of adverse events
Time Frame:	Up to 48 weeks
Safety Issue:
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.

Measure:	Proportion of patients with PSA response (Cohort 1)
Time Frame:	Up to 48 weeks
Safety Issue:
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.

Measure:	Time to PSA progression (Cohort 1)
Time Frame:	Time from randomization to PSA progression, assessed up to 48 weeks
Safety Issue:
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.

Measure:	Time to initiation of additional therapy (Cohort 2)
Time Frame:	Baseline up to 48 weeks
Safety Issue:
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.

Measure:	Time to progression (Cohort 2)
Time Frame:	From randomization to progression, assessed up to 48 weeks
Safety Issue:
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.

Details

Phase:	Phase 2
Primary Purpose:	Interventional
Overall Status:	Recruiting
Lead Sponsor:	City of Hope Medical Center

Last Updated

August 26, 2021

Clinical Trials /

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