Bone Metastases Clinical Trial
Official title:
Randomized Phase II Trial of Sipuleucel T Immunotherapy Preceded by Sensitizing Radiation Therapy and Sipuleucel-T Alone in Patients With Castrate Resistant Metastatic Prostate Cancer
This randomized phase II trial studies how well giving sipuleucel-T with or without radiation therapy works in treating patients with hormone-resistant metastatic prostate cancer. Vaccines may help the body build an effective immune response to kill tumor cells. Radiation therapy uses high energy x rays to kill tumor cells. It is not yet known whether giving sipuleucel-T vaccine is more effective with or without radiation therapy in treating prostate cancer
PRIMARY OBJECTIVES:
I. To assess the feasibility, based on percent able or willing to receive all three infusions
of sipuleucel-T immunotherapy, when combining sipuleucel-T with radiation therapy to a single
site of metastasis delivered one week prior to beginning of sipuleucel-T therapy.
SECONDARY OBJECTIVES:
I. To assess the effect of radiation therapy to single metastasis on immune response
(antibody and T-cell proliferation to prostate acid phosphate [PAP] and fusion protein
PA2024) generated by sipuleucel-T immunotherapy.
II. To assess the effect of external beam radiotherapy to single metastasis on prostate
specific antigen (PSA) response to therapy with sipuleucel-T.
III. To assess the effect of external beam radiotherapy to single metastasis on radiographic
response rate to therapy with sipuleucel-T.
IV. To assess the time from the onset of therapy with sipuleucel-T +/- radiation to the need
for subsequent therapy for prostate cancer.
V. To assess the toxicity associated with sipuleucel-T +/- radiation.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM A: Patients receive sipuleucel-T intravenously (IV) over 60 minutes days 22, 36, and 50.
ARM B: Patients undergo external beam radiation therapy in weeks 1-2. Patients also receive
sipuleucel-T as in Arm A.
In both arms, treatment continues in the absence of disease progression or unacceptable
toxicity.
After completion of study treatment, patients are followed up until week 60.
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