Dendreon Lymph Node Biopsy in Metastatic Castrate-Resistant Prostate Cancer

Inclusion Criteria:

Age ≥ 18 years
ECOG performance status 0 or 1
Life expectancy of ≥ 6 months

Minimally-symptomatic or asymptomatic, castrate-resistant metastatic prostate cancer, as evidenced by all of the following:

Histologically-confirmed diagnosis of adenocarcinoma of the prostate

Evidence of adequate androgen deprivation, as evidence by one of the following:

Bilateral orchiectomy
Ongoing LHRH agonist (e.g. leuprolide, goserelin) and serum testosterone <50 ng/dl
Ongoing LHRH antagonist (e.g. degarelix) and serum testosterone <50 ng/dl

Evidence of prostate cancer resistance to castration, as evidenced by one of the following:

2 consecutive PSA levels that are ≥ 50% above the PSA nadir achieved on ADT and obtained at least 1 week apart
CT or MRI based evidence of disease progression (soft tissue or nodal) according to PCWG2 criteria or RECIST 1.1 criteria, or at least 1 new bone scan lesion as compared to the most immediate prior radiologic studies.
Presence of non-visceral metastases on imaging

Absence of major symptoms directly attributable to prostate cancer, with the following permissible exceptions:

Ureteral obstruction secondary to pelvic or retroperitoneal lymphadenopathy
Bladder outlet obstruction secondary to locally recurrent prostate cancer
Radiographic evidence of lymphadenopathy, defined as a lymph node greater than 1 cm in diameter on axial imaging (CT or MRI or PET/CT)
Adequate laboratory parameters
A minimum of 4 weeks from any major surgery prior to registration. Coincident standard of care surgery with the research biopsy is permitted during the study.

Exclusion Criteria:

Prior treatment with sipuleucel-T
Allergy to any component of sipuleucel-T
Inability to undergo leukapheresis
History of neuroendocrine variants of prostate cancer, including small cell carcinoma of the prostate
Extensive prior surgery/radiation present that would render the biopsy highly complex and the risk of intraoperative injury high
Any chronic medical condition requiring daily corticosteroids or other immunosuppressants
Solid organ transplantation requiring immunosuppression
Visceral (e.g. lung, liver) metastases
Known brain metastases
History of spinal cord compression
Untreated/unstabilized pathologic long bone fractures
Other malignancy, except non-melanoma skin cancer, with a ≥ 30% probability of recurrence within 24 months
Administration of any investigational therapeutic within 30 days of registration
Any condition which, in the opinion of the investigator, would preclude participation in this trial