NCT01807065

Sipuleucel-T With or Without Radiation Therapy in Treating Patients With Hormone-Resistant Metastatic Prostate Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Adenocarcinoma of the Prostate
• Bone Metastases
• Hormone-resistant Prostate Cancer
• Recurrent Prostate Cancer
• Soft Tissue Metastases
• Stage IV Prostate Cancer

Interventions

Type	Name	Description
BIOLOGICAL	sipuleucel-T	Given IV
RADIATION	external beam radiation therapy	Undergo external beam radiation therapy
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2013-06-07
• Primary completion: 2018-12-31
• Completion: 2019-12-31
• First posted: 2013-03-08
• Last updated: 2020-08-25
• Results posted: 2020-08-25

Locations

3 sites across 1 country: United States