This phase II trial studies how well sipuleucel-T and stereotactic body radiation therapy (stereotactic ablative body radiation therapy) work in treating patients with prostate cancer that does not respond to hormone therapy that has spread to other places in the body (metastatic). Vaccines made from a person’s white blood cells mixed with tumor proteins may help the body build an effective immune response to kill prostate cancer cells. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving sipuleucel-T with stereotactic ablative body radiation therapy may kill more tumor cells.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01818986.
PRIMARY OBJECTIVES:
I. To evaluate the improvement in the time to progression (TTP) of metastatic prostate cancer after the combined treatment with sipuleucel-T and stereotactic body radiation therapy (SABR) to metastatic sites, as compared to the historically reported data with the treatment of sipuleucel-T alone.
SECONDARY OBJECTIVES:
I. To quantify the amplification in immune response generated by sipuleucel-T by the addition of SABR.
II. To evaluate the improvement in the overall survival (OS) of metastatic castrate-resistant prostate cancer (mCRPCa) patients after the combined treatment with sipuleucel-T and SABR to metastatic sites, as compared to the historically reported data with the treatment of sipuleucel-T alone.
III. To evaluate the improvement in the progression free survival (PFS) of mCRPCa patients after the combined treatment with sipuleucel-T and SABR to metastatic sites, as compared to the historically reported data with the treatment of sipuleucel-T alone.
IV. To evaluate the improvement in the biochemical progression free survival (bPFS) of mCRPCa patients after the combined treatment with sipuleucel-T and SABR to metastatic sites, as compared to the historically reported data with the treatment of sipuleucel-T alone.
V. To evaluate the improvement in the prostate cancer-specific survival (PCaSS) of mCRPCa patients after the combined treatment with sipuleucel-T and SABR to metastatic sites, as compared to the historically reported data with the treatment of sipuleucel-T alone.
VI. To evaluate the adverse events for the first 6 months after completion of radiation therapy associated with sipuleucel-T when administered in combination with SABR to metastatic sites, as compared to the historically reported data with the treatment of sipuleucel-T alone.
VII. To evaluate the cost effectiveness and health-related quality adjusted life of the combination treatment of SABR and sipuleucel-T in patients with mCRPC.
TERTIARY OBJECTIVES:
I. To characterize the nature of immune response by the measurement of the relative presence of different subpopulations of immunocytes and by the levels of their regulatory cytokines in patient sera as well as within the metastatic sites.
II. To compare the cost effectiveness and improvement of quality of life of this combination treatment to the other current standards of care for mCRPC patients (i.e. docetaxel, sipuleucel-T alone, etc.).
OUTLINE:
Patients receive sipuleucel-T intravenously (IV) over 60 minutes on day 1 of weeks 1, 3, and 5. Patients also undergo 1 or 3 fractions of stereotactic body radiation therapy during weeks 3-4. Treatment repeats every 14 days for 2 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 weeks and every 3 months for the first 36 weeks, every 12 weeks until 2 years, every 6 months for 2 years, and then periodically thereafter.
Lead OrganizationUT Southwestern/Simmons Cancer Center-Dallas
Principal InvestigatorRaquibul Hannan
