White Button Mushroom Extract in Treating Patients With Recurrent Prostate Cancer After Local Therapy

NCT00779168 | Completed Phase 1 DMC

• 4 other identifiers: 08012P30CA033572CHNMC-08012CDR0000617012
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: White button mushroom extract may stop or delay the development of recurrent prostate cancer. PURPOSE: This phase I trial is studying the side effects and best dose of white button mushroom extract in treating patients with recurrent prostate cancer after local therapy.

Conditions

Prostate Cancer

Keywords

recurrent prostate cancer; adenocarcinoma of the prostate

Outcome Measures

Primary Outcomes (1)

• Feasibility and toxicity of this regimen at six different dose levels

  1 year after treatment on study

Secondary Outcomes (2)

• Effect on testosterone, dihydrotestosterone, dehydroepiandrosterone, estrogens, aromatase, parameters of the immune function, and circulating tumor cells

  1 year after treatment on study

• Effect on PSA kinetics

  1 year after treatment on study

Study Arms (1)

Treatment (enzyme inhibitor therapy)

EXPERIMENTAL

Patients receive white button mushroom extract PO twice daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

Drug: white button mushroom extract; Other: flow cytometry; Other: immunologic technique; Other: laboratory biomarker analysis; Other: gas chromatography-mass spectrometry; Other: pharmacological study

Interventions

white button mushroom extract DRUG

For this dose escalation study 6 patients will be treated at each of the following dosages: 4 grams PO daily, 6 grams PO daily, 8 grams PO daily, 10 grams PO daily, 12 grams PO daily and 14 grams PO daily.

Treatment (enzyme inhibitor therapy)

flow cytometry OTHER

Immune cell subset number will be evaluated by flow cytometry on blood samples collected on days -14, -7, 1, 15, 29, 57, 85 from treatment and when coming off study.

Treatment (enzyme inhibitor therapy)

immunologic technique OTHER

Testing will be performed on blood samples collected on days -14, -7, 1, 15, 29, 57, 85 from treatment and when coming off study.

Treatment (enzyme inhibitor therapy)

laboratory biomarker analysis OTHER

Performed on blood samples collected pre-study (within 4 weeks of registration) and during weeks 3, 5, 9, 13, every 4 weeks beyond week 13 and at off study.

Treatment (enzyme inhibitor therapy)

gas chromatography-mass spectrometry OTHER

Gas Chromatography-Mass Spectrometry (GC-MS) will be used to evaluate C-18 unsaturated fatty acids (CUFA) in blood samples collected on days -14, -7 prior to start of treatment. On day 1 of week 1 blood will be drawn at pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, and 6 hours post-dose and subsequently on days 15, 29, 57 and 85 and when coming off study.

Treatment (enzyme inhibitor therapy)

pharmacological study OTHER

Evaluation of C-18 unsaturated fatty acids (CUFA) in blood samples collected on days -14, -7 prior to start of treatment. On day 1 of week 1 blood will be drawn at pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, and 6 hours post-dose and subsequently on days 15, 29, 57 and 85 and when coming off study.

Treatment (enzyme inhibitor therapy)

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have a histologically or cytologically confirmed history of adenocarcinoma of the prostate Patients must have a PSA failure defined as PSA of \>= 0.2 ng/ml that has increased above nadir following prostatectomy If radiation or other local therapy was used as a primary therapy and no prostatectomy was performed patients must have PSA increase of 2.0 above post-therapy nadir; PSA value must be increasing based on two consecutive measurements each separated by at least 2 weeks with no clinical or radiographic evidence of metastatic disease; PSA values that meet the criteria for eligibility within 4 weeks of registration are acceptable to document eligibility for enrollment on this study; PSA level obtained after registration and prior to the first course will be used as the "baseline" PSA as per the schema but will not determine eligibility for participation
• Patients must have had at least three PSA measurements over a minimum of three months available prior to enrollment to this study
• Patients may have received any number of local therapies (radical prostatectomy, external beam radiation therapy, radioactive seed implantation, cryotherapy)
• Bone scan and computed tomography (CT) scan of the chest, abdomen and pelvis negative for metastatic disease within 2 months prior to registration
• Patients must have a performance status of 0, 1, or 2
• All patients will have malignancy confirmed by review of their biopsy specimens by the Division of Pathology, City of Hope National Medical Center; if no pathological specimen is available for review, the patient may still be included if the patient has clearly documented prostate cancer per pathology report and a specimen request is documented as having been made for tissue from the outside facility but a specimen was unable to be obtained
• Serum creatinine =\< 2.5 mg/dL
• Baseline liver function tests including bilirubin =\< 1.5 x the institutional upper limit of normal and serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) =\< 2.5 x the institutional upper limit of normal
• White blood cells (WBC) \>= 2000
• Platelets \>= 50,000

You may not qualify if:

• Patients with evidence of metastatic disease
• PSA progression not verified by sequential rising PSA as discussed in the eligibility section
• Patients who have received prior cytotoxic chemotherapy or androgen ablative therapy for recurrent disease
• Patients currently receiving biological response modifiers, or corticosteroids
• Patients are permitted to have received up to 24 months of neoadjuvant or adjuvant hormone ablation in conjunction with their primary definitive therapy; androgen deprivation must have been completed at least 6 months prior to registration and testosterone level must be \> 50; no complementary or alternative therapy (e.g. St. John's Wort, PC-SPES, or other herbal remedies taken for the purpose of treating prostate cancer) may be given during protocol treatment; patients are allowed to have received neoadjuvant and/or adjuvant chemotherapy that was completed at least 6 months prior to registration to the protocol
• Uncontrolled intercurrent illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/ social situations that would limit compliance with study requirements
• Patients with known allergy to mushrooms

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

City of Hope Medical Center

Duarte, California, 91010-3000, United States

Location

South Pasadena Cancer Center

South Pasadena, California, 91030, United States

Location

Related Publications (1)

• Twardowski P, Kanaya N, Frankel P, Synold T, Ruel C, Pal SK, Junqueira M, Prajapati M, Moore T, Tryon P, Chen S. A phase I trial of mushroom powder in patients with biochemically recurrent prostate cancer: Roles of cytokines and myeloid-derived suppressor cells for Agaricus bisporus-induced prostate-specific antigen responses. Cancer. 2015 Sep 1;121(17):2942-50. doi: 10.1002/cncr.29421. Epub 2015 May 18.

  PMID: 25989179 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Flow Cytometry; Immunologic Techniques; Gas Chromatography-Mass Spectrometry

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Investigative Techniques; Chromatography, Gas; Chromatography; Mass Spectrometry

Study Officials

• Cy Stein, MD, PhD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2008
• First Posted: October 24, 2008
• Study Start: January 29, 2009
• Primary Completion: June 10, 2021
• Study Completion: June 10, 2021
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

US (2)