Clinical Trials Logo
NCT number NCT00779168
Study type Interventional
Source City of Hope Medical Center
Contact
Status Active, not recruiting
Phase Phase 1
Start date September 26, 2008
Completion date July 2018

Clinical Trial 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.


Clinical Trial Description

OBJECTIVES:

Primary

- To assess the feasibility and toxicity of prolonged white button mushroom extract therapy at six different dose levels in patients with biochemically recurrent prostate cancer after local therapy.

Secondary

- To analyze the effect of this regimen on a variety of biomarkers including testosterone, dihydrotestosterone, dehydroepiandrosterone, estrogens, aromatase, parameters of immune function, and circulating tumor cells.

- To assess the effect of this regimen on PSA kinetics as a measure of disease activity in these patients.

OUTLINE: This is a dose-escalation study.

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

Blood and urine samples are collected periodically for pharmacokinetic, pharmacodynamic, and immunologic correlative studies. Plasma and urine samples are analyzed for quantification of conjugated unsaturated fatty acids via gas chromatography-mass spectometry. Plasma samples are analyzed for inhibition of aromatase via aromatase activity analysis and the effect of treatment on immune cytokines levels via immunobiologic assays. Peripheral blood mononuclear cells are analyzed for the effect of treatment on immune cell subsets and NK cell function via multi-parameter flow cytometry; effect of treatment on NK cell activation status via staining method; and measurement of circulating tumor cells via fluorescence microscopy, fiber-optic array scanning technology (FAST), or high-speed flow cytometry. Additional serum samples are collected for future studies.

Patients complete a diary listing days of administration of treatment and side effects.


Study Design


Related Conditions & MeSH terms


See also
  Status Clinical Trial Phase
Recruiting NCT03177759 - Living With Prostate Cancer (LPC) N/A
Recruiting NCT03101176 - Multiparametric Ultrasound Imaging in Prostate Cancer N/A
Recruiting NCT03290417 - Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer N/A
Completed NCT00341939 - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data N/A
Recruiting NCT02945813 - SAKK 08/15 - PROMET - Salvage Radiotherapy +/- Metformin for Patients With Prostate Cancer After Prostatectomy Phase 2
Recruiting NCT03271502 - Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy N/A
Completed NCT02124668 - A Study to Monitor the Safety of Enzalutamide in Patients With Progressive Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy Phase 2
Completed NCT01943500 - Collection of Blood Specimens for Circulating Tumor Cell Analysis N/A
Recruiting NCT02799706 - Trial Comparing Irradiation Plus Long Term Adjuvant Androgen Deprivation With GnRH Antagonist Versus GnRH Agonist Plus Flare Protection in Patients With Very High Risk Localized or Locally Advanced Prostate Cancer Phase 3
Recruiting NCT01990196 - Neoadjuvant Phase 2 Study Comparing the Effects of AR Inhibition With/Without SRC or MEK Inhibition in Prostate Cancer Phase 2
Recruiting NCT02766543 - Pivotal Study of MRI-guided Transurethral Ultrasound Ablation in Patients With Localized Prostate Cancer Phase 2
Recruiting NCT03134027 - Reconstitution of a Human Immune System in a Patient Derived Xenograft (PDX) Model of Genitourinary (GU) Cancers N/A
Not yet recruiting NCT03256630 - Evaluation of Urine and Blood Biomarkers to Try and Distinguish Between the Presence or Absence of Aggressive Prostate Cancer N/A
Not yet recruiting NCT03263780 - High Resolution PET-MRI Before Prostate Cancer HIFU Early Phase 1
Not yet recruiting NCT03284684 - Kinetics of Perioperative Circulating DNA in Cancer Surgery N/A
Recruiting NCT02911922 - Randomized Trial of Image -Guided Stereotactic Radiation Therapy (IG-SRT) in Prostate Cancer N/A
Recruiting NCT02916537 - A Phase 1 Trial for Safety and Imaging Evaluation of CTT1057, a Small Molecule Inhibitor of Prostate Specific Membrane Antigen (PSMA) Phase 1
Recruiting NCT02886598 - Safety and Efficacy of Firmagon® (Degarelix) for Injection N/A
Recruiting NCT02906241 - PACCT: Partnering Around Cancer Clinical Trials N/A
Recruiting NCT02918357 - Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence Phase 2/Phase 3