Prostate Cancer Clinical Trial
Official title:
A Phase Ib Trial of Mushroom Powder in Biochemically Recurrent Prostate Cancer
Verified date | March 2022 |
Source | City of Hope Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 36 |
Est. completion date | June 10, 2021 |
Est. primary completion date | June 10, 2021 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | City of Hope Medical Center | Duarte | California |
United States | South Pasadena Cancer Center | South Pasadena | California |
Lead Sponsor | Collaborator |
---|---|
City of Hope Medical Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility and toxicity of this regimen at six different dose levels | 1 year after treatment on study | ||
Secondary | Effect on testosterone, dihydrotestosterone, dehydroepiandrosterone, estrogens, aromatase, parameters of the immune function, and circulating tumor cells | 1 year after treatment on study | ||
Secondary | Effect on PSA kinetics | 1 year after treatment on study |
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