Sipuleucel-T with or without Radium Ra 223 Dichloride in Treating Patients with Asymptomatic or Minimally Symptomatic Bone-Metastatic Hormone-Resistant Prostate Cancer

Inclusion Criteria

• Written informed consent provided prior to the initiation of study procedures
• Histologically documented adenocarcinoma prostate cancer confirmed by a pathology report from prostate biopsy or a radical prostatectomy specimen; if prostatic tumor is of mixed histology, > 50% of the tumor must be adenocarcinoma
• Bone metastases as manifested by one or more lesions on a bone scan performed within 2 months of screening
• Castrate-resistant prostate cancer, in the setting of castrate levels of testosterone (=< 50 ng/dL), defined as current or historical evidence of disease progression concomitant with surgical castration or androgen deprivation therapy (ADT), as demonstrated by two consecutive rises in PSA OR new lesions on bone scan: * PSA progression will be defined as 2 rising PSA values compared to a reference value, measured at least 7 days apart and the second value is >= 2 ng/mL; it must be documented within 2 months of screening * Appearance of one or more new areas of abnormal uptake on bone scan when compared to imaging studies acquired during castration therapy or against the pre-castration studies if there was no response; increased uptake of pre-existing lesions on bone scan does not constitute progression; it must be documented within 4 months of screening
• Serum PSA >= 2.0 ng/mL
• Screening Eastern Cooperative Oncology Group (ECOG) performance status =< 1
• Asymptomatic or minimally symptomatic disease (no narcotic analgesic; other analgesics use is allowed)
• Prior abiraterone and enzalutamide are permitted, but not required
• Concurrent osteoclast-inhibitory therapies (zoledronic acid, denosumab) are permitted if patients have been on a stable dose for at least 1 month
• Absolute neutrophil count (ANC) >= 1.5 x10^9/L (=< 28 days prior to registration)
• Platelet count >= 100 x10^9/L (=< 28 days prior to registration)
• Hemoglobin >= 10.0 g/dL (=< 28 days prior to registration)
• Total bilirubin level =< 1.5 x institutional upper limit of normal (ULN) (=< 28 days prior to registration)
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN (=< 28 days prior to registration)
• Creatinine =< 1.5 x ULN (=< 28 days prior to registration)
• Albumin > 25 g/L (=< 28 days prior to registration)

Exclusion Criteria

• The presence of known lung or liver metastases greater than 1.0 cm in the long-axis diameter
• The presence of lymphadenopathy greater than 3 cm in the short-axis diameter
• The presence of known brain metastases
• Spinal cord compression, imminent long bone fracture, or any other condition that, in the opinion of the investigator, is likely to require radiation therapy and/or steroids for pain control during the active phase
• Previous treatment with chemotherapy for metastatic (m)CRPC or chemotherapy for any reason within 6 months prior to registration; (chemotherapy in the adjuvant setting or for hormone-sensitive prostate cancer is permitted, as long as it was completed more than 6 months before registration)
• Intention to receive chemotherapy within 6 months after enrollment in protocol therapy
• History of radiation therapy, either via external beam or brachytherapy within 28 days prior to registration
• Systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within previous 24 weeks
• Prior history of other cancers (except non-melanoma skin cancers or low-grade low-stage urothelial cancers), or other localized cancers without evidence of recurrence for at least 3 years
• Use of prednisone or equivalent systemic corticosteroid within 2 weeks of sipuleucel-T; use of inhaled, intranasal, intra-articular, and topical steroids is allowed; oral or IV steroids to prevent or treat IV contrast reactions are allowed
• Use of opioid analgesics for cancer-related pain
• Use of experimental drug within 4 weeks of treatment
• Uncontrolled medical conditions including diabetes, heart failure, chronic obstructive pulmonary disease (COPD), ulcerative colitis, or Crohn’s disease
• Uncontrolled fecal incontinence
• Any medical intervention, any other condition, or any other circumstance which, in the opinion of the investigator, could compromise adherence with study requirements or otherwise compromise the study’s objectives