Study to Assess the Activity of Nexrutine® in Prostate Cancer Patients
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Nexrutine
Intervention description: Nexrutine 500mg by mouth, three times per day, given prior to surgery or prior to and during radiation treatment.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: nexrutine; prostate cancer

Summary:

      The purpose of the study is to (1) to determine the rate of PSA decline (the number
      declining). Tissue will be obtained for ancillary studies and (2) to determine the number of
      patients with a PSA decline to <1.0 ng/ml at 3 months in patients receiving Nexrutine® with
      standard radiation therapy. The Secondary Objective is to confirm the tolerability of this
      regimen. The Third Objective (Ancillary studies) is To evaluate the molecular response of
      Nexrutine®. Molecular response is defined as changes in the molecular pathways.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Have a histologic diagnosis of prostate cancer (in more than 1 core) with one of the
             following:

               -  Gleason > 6,

               -  Unilateral Gleason 6 in ≥ 3 cores,

               -  bilateral Gleason 6,

               -  PSA > 10.0 ng/ml.

          2. Age ≥18 years.

          3. Has an ECOG Performance Status 0-2 or Karnofsky 60-100.

          4. Has the following laboratory values at study entry: absolute neutrophil count (ANC) ≥
             1,500 cells/μL; platelet count ≥ 100,000 cells/μL; hemoglobin ≥ 9 g/dL; total serum
             bilirubin ≤ 1.5 x institutional upper limit of normal (ULN); ALT and AST ≤ 1.5 x
             institutional ULN if alkaline phosphatase is ≤ULN creatinine and BUN ≤ 1.5 x
             institutional upper limit of normal (ULN)

          5. Signed informed consent

          6. No new, undiagnosed bone pain or has a negative bone scan. (within 2 months of
             consent) If there is no bone pain, then a bone scan is not required.

        Exclusion Criteria:

          1. Has documented metastatic disease.

          2. Has received a prior chemotherapy or androgen ablation.

          3. Has received prior immunotherapy.

          4. Has been previously treated with Strontium, Samarium, other systemic radioisotopes or
             radiation therapy.

          5. Has diagnosis of congestive heart failure

          6. Currently taking anticoagulation medications, i.e., coumadin or heparin. Over the
             counter aspirin and ibuprofen are allowed.

          7. Is receiving any other investigational agents for cancer.

          8. Has a history of other malignancy within the last 5 years, which could affect the
             diagnosis or assessment of prostate cancer.

          9. Has a serious intercurrent illness with a life expectancy of less than 5 years.

         10. Has a concomitant medical, psychological, or social circumstance, which would
             interfere with compliance with the protocol treatment and follow-up.

         11. Use of any herbal or alternative regimens, which may have antineoplastic or hormonal
             activity (including but not limited to finasteride, dutasteride, Saw Palmetto,
             PC-SPES, shark cartilage, etc), is prohibited while receiving study treatment.

         12. Clinical stage T3 or T4 and PSA >10 ng/ml and Gleason > 8.

         13. Patient is to receive adjuvant androgen ablation with the radiation.

         14. EKG which shows a baseline QTc > 450 msec or ischemic changes. For ischemic changes,
             patient will be eligible if evaluated and cleared by internal medicine.

         15. Previous history of drug-induced QTc prolongation and/or concurrent treatment with
             medications that are known to produce or are suspected of QT prolongation.