Safety: To evaluate the number, frequency, duration, and relation of toxicity events to eRapa, as defined by the Common Terminology Criteria for Adverse Events (CTCAE) v 4.03; analyzed overall and compared between dosing cohorts. Also assessed based on duration of treatment.
This tissue bank will store epithelial cell samples from prostate biopsies and measure Prostate Specific Antigen (PSA) and Prostate Specific Membrane Antigen (PSMA) in the urine specimens for future scientific research studies. The stored specimens will be used for research investigating the causes of prostate diseases, the methods for improving diagnosis, and highly aggressive forms from less aggressive forms of prostate cancers.
The San Antonio Center of Biomarkers of Risk for Prostate Cancer (SABOR), is a long-term research study of a large group of men that will help researchers improve the detection of prostate cancer. The program provides annual PSA (Prostate Specific Antigen) screening at no cost. Subjects participating in this study will be asked to attend one visit per year for PSA screening and complete annual follow-up phone interviews. Written PSA results will be provided to you, and if you request, to your provider
This study is designed as a cross-sectional, exploratory pilot study to examine the onset and progression of cancer-related fatigue in prostate cancer patients. The goal of this project is to report the effect of fatigue on quality of life and pilot a novel salivary biomarker to measure fatigue. One hundred men, diagnosed with prostate cancer and 200 men without prostate cancer will be recruited to participate in this study. Detailed medical and medication history will be reviewed to determine if subjects are eligible to participate in this study. All eligible participants will be recruited to participate in this study. All activities will be done during the patients regularly scheduled visit with their oncologist at the CTRC. Each subject will sign an informed consent form indicating their willingness to participate after which they will complete a battery of survey instruments and provide a 4 mL saliva sample. Saliva will be used to assess concentrations of a fatigue biomarkers in this study and banked for future research studies. The total length of time for study participation for each subject should be less than 1 hour.
Darpan Patel, Ph.D.