Dendreon Lymph Node Biopsy in Metastatic Castrate-Resistant Prostate Cancer
Prostate Cancer
About this trial
This is an interventional other trial for Prostate Cancer focused on measuring castrate resistant prostate cancer, metastatic, sipuleucel-T, lymphadenectomy, Excisional lymph node biopsy
Eligibility Criteria
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
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Arm A
Arm B
Pre-treatment control group will be randomized to immediate lymph node biopsy followed by sipuleucel-T immunotherapy.
Post-treatment experimental group will be randomized to immediate sipuleucel-T immunotherapy followed by lymph node biopsy.