Study of Sipuleucel-T W/ or W/O Radium-223 in Men With Asymptomatic or Minimally Symptomatic Bone-MCRPC

Inclusion Criteria:

Written informed consent provided prior to initiation of study procedures
Age ≥ 18 years
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 [1]. 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 precastration 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 ECOG perf 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

Adequate screening hematologic, renal, and liver function as evidenced by laboratory test results within the following ranges ≤ 28 days prior to registration:

Absolute neutrophil count (ANC) ≥ 1.5 x109/L
Platelet count ≥ 100 x109/L
Hemoglobin ≥ 10.0 g/dL
Total bilirubin level ≤ 1.5 x institutional upper limit of normal (ULN)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
Creatinine ≤ 1.5 x ULN
Albumin > 25 g/L

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 mCRPC (adjuvant chemotherapy is permitted), or chemotherapy for any reason within 2 years prior to 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)
Use of prednisone or equivalent systemic corticosteroid within 2 weeks of treatment. 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, 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