Trial of eRapa in Prostate Cancer Patients

Inclusion Criteria:

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The patient must:

Have pathologically (histologically) proven diagnosis of prostate cancer with a Gleason score ≤7 (3+4) and already undergoing active surveillance
Be able to give informed consent
Be age 18 or older

Exclusion Criteria:

Prostate cancer with a Gleason score >7
Unable to give informed consent
Age < 18
Immunosuppressed state (e.g., HIV, use of chronic steroids)
Active, uncontrolled infections
On medications with strong inhibitors or inducers of CYP3A4 and or P-gp.
On agents known to alter rapamycin metabolism significantly (Appendix H)
Have another cancer requiring active treatment (except basal cell carcinoma or squamous cell carcinoma of the skin)
Individuals with a reported history of liver disease (e.g., cirrhosis)
Individuals who are not a good candidate for active surveillance in their treating physician's opinion
Have a medical condition (e.g., anemia, anticoagulated) for which repeated phlebotomy may be problematic.
Uncontrolled hypertension.

Individuals that have abnormal screening vital organ function prior to enrollment

Liver Function Test

Bilirubin >2.0
Alkaline phosphatase >5x upper limit of normal (ULN)
ALT/AST >2x ULN

Complete Blood Count:

WBC elevated above the normal standard per the testing laboratory
Hgb/Hct below the normal standards of the testing lab
Platelets below the normal standards of the testing lab
Total Cholesterol >240 mg/dL
Triglycerides > 200 mg/dL
Serum creatinine >2 and BUN >30
Urinary protein: proteinuria >1+ on urinalysis or >1 gm/24hr