Sipuleucel-T and Stereotactic Ablative Body Radiation (SABR) for Metastatic Castrate-resistant Prostate Cancer (mCRPC)
Condition: Metastatic Castrate-resistant Prostate Cancer; mCRPC
MeSH terms: Prostatic Neoplasms
Intervention: Sipuleucel-T; Stereotactic Ablative Body Radiation
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      In this i-SABR (immunotherapy + Stereotactic Ablative Body Radiation) trial, the stereotactic
      radiation to multiple metastatic sites is delivered not only to eradicate sites of bulky
      progressive disease, but also to provide antigen presentation and immune stimulation which is
      expected to act synergistically to the concurrently administered immunotherapy Sipuleucel-T
      and thereby significantly improve the treatment outcome for metastatic castrate resistant
      prostate cancer patients (mCRPC). Both Sipuleucel-T and SABR are FDA approved therapeutic
      cancer treatment
    

Eligibility criteria:

        Inclusion Criteria:

          1. Biopsy proven prostate cancer

          2. Patient must currently be on androgen deprivation or anti-androgen therapy with
             castrate levels of testosterone (< 50ng/dl). Medical castration should continue until
             disease progression

          3. Radiographic evidence of metastatic disease documented with bone scan or CT scan.
             Patients with any number of metastatic site are allowed to enroll. However, only up to
             six sites will be selected for SBRT treatment, at the discretion of the treating
             radiation oncologist.

          4. PSA ≥ 5 ng/ml

          5. Asymptomatic or minimally symptomatic patients1. Visual Analog Scale (VAS) ≤ 4;vNo
             narcotic use in the last 21 days

          6. Adequate hematologic, renal, and liver function

          7. Previous treatment with surgery, radiation or hormonal therapy is allowed.

          8. Performance status ECOG 0 or 1.

          9. Life expectancy of at least 6 months

         10. Negative serology tests for human immunodeficiency virus (HIV) 1 and 2, human T cell
             lymphotropic virus (HTLV)-1, Hepatitis B and C.

         11. Age ≥ 18 years.

         12. Ability to understand and the willingness to sign a written informed consent

        Exclusion Criteria:

          1. Subjects must not have had more than two different regiments of chemotherapy
             previously or any chemotherapy within the past three months.

          2. Subjects may not be receiving any other investigational agents for the treatment of
             prostate cancer.

          3. Subjects with known brain metastases should be excluded from this clinical trial
             because of their poor prognosis and because they often develop progressive neurologic
             dysfunction that would confound the evaluation of neurologic and other adverse events.

          4. Subjects with malignant pleural effusions and malignant ascites

          5. Systemic corticosteroid use within past 28 days. Use of inhaled, intranasal, and
             topical steroids is acceptable.

          6. Systemic immunosuppressive therapy in the past 28 days.

          7. Use of any of the following within the past 28 days: Megestrol acetate (Megace®),
             diethyl stilbestrol (DES), or cyproterone acetate, Ketoconazole, high dose calcitriol
             [1,25(OH)2VitD] (i.e., > 7.0 μg/week).

          8. Inability to tolerate contrast dye for baseline CT imaging.

          9. Initiation or discontinuation of biphosphonate use within past 28 days.

         10. Subjects with pathologic long-bone fractures

         11. Subjects with spinal cord compression

         12. Paget's disease of bone.

         13. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements.