Pasireotide (SOM230) With or Without Everolimus in Treating Patients With Hormone Resistant, Chemotherapy Naive Prostate Cancer
Condition: Castrate Resistant Prostate Cancer; Chemotherapy Naive Prostate Cancer; Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Pasireotide; Everolimus; Laboratory biomarker analysis
Intervention description: Given IM; Given PO; Correlative studies
Intervention MeSH terms: Everolimus; Pasireotide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Castrate Resistant; Chemotherapy Naive; Prostate Cancer; SOM230; Everolimus

Summary:

      This is an open label randomized phase II study for prostate cancer patients who have disease
      progression after hormonal therapy. SOM230 LAR (Pasireotide) binds to its receptor of
      prostate cancer cells and can prevent them from growing. Everolimus works by targeting a cell
      survival factor in prostate cancer. The combination of these drugs may work better for the
      treatment of prostate cancer without toxic chemotherapy. Patients will receive either SOM230
      LAR (group A) or SOM230 LAR in combination with Everolimus (group B).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age minimum: 18 years old

          -  Histological confirmation of prostatic adenocarcinoma

          -  PSA > or = to 2 ng/ml

          -  PSA progression (serially rises on two occasions each at least one week apart) OR
             disease progression on imaging studies (CT scan or bone scan).

          -  Minimally symptomatic - no symptoms attributed to prostate cancer greater than Grade I
             based on NCI CTCAE Version 4.0 grading of toxicities

          -  Discontinuation of all antiandrogen, ketoconazole and investigational drugs for at
             least 4 weeks (6 weeks for bicalutamide) prior to study initiation

          -  Maintain castrate levels of testosterone (<50ng/dL)

          -  Karnofsky Performance Status > or = to 60%

          -  Life expectancy > 3 months

          -  Adequate hematologic, renal, and liver function

        Exclusion Criteria:

          -  Currently active second malignancy other than non-melanoma skin cancers.

          -  Clinically significant cardiovascular disease: EF < 30%, NHYA Class III or greater
             congestive heart failure, myocardial infarction/unstable angina within 6 months prior
             to study enrollment, or significant ECG abnormalities such as QRS/QT prolongation (see
             Section 5.3).

          -  Progressive pulmonary disease, such as advanced COPD, pulmonary fibrosis, or
             supplemental O2 requirement.

          -  Known CNS disease, except for treated brain metastases.

          -  Poorly controlled diabetes mellitus (HbA1c > 7 %) or fasting blood glucose level >126
             mg/dL in non-diabetic patients or > 189 mg/dL in diabetic patients (can be enrolled
             after initiation or titration of anti-diabetic agent(s)).

          -  Poorly controlled hypercholesterolemia (fasting serum cholesterol >300 mg/dL) or
             hypertriglyceridemia (> 2.5 x ULN). Patients above either threshold can be included
             after initiation of appropriate lipid lowering medication.

          -  Current use of chronic steroids (equivalent of 20mg prednisone daily). Inhaled
             steroids are acceptable.

          -  Active gallbladder disease or hepatitis (AST or ALT > 2.0, or bilirubin > 1.5x ULN),
             liver cirrhosis, or severe liver impairment (Child-Pugh class C). It is highly
             recommended that patients positive for HBV-DNA or HBsAg are treated prophylactically
             with an antiviral for 1-2 weeks prior to receiving study drug.

          -  Serum creatinine >1.5 upper limit of normal or on dialysis.

          -  Prior use of a somatostatin analog or mTOR inhibitor for the treatment of PC.