Provenge With or Without pTVG-HP DNA Booster Vaccine in Prostate Cancer

Inclusion Criteria:

- Histologically confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate)

- Metastatic disease as evidenced by the presence of soft tissue and/or bone metastases
on imaging studies (computed tomography [CT] of abdomen/pelvis, bone scintigraphy)

- Castrate-resistant disease, defined as follows:

- All patients must have received standard of care androgen deprivation treatment
before trial entry (surgical castration versus gonadotropin-releasing hormone
[GnRH] analogue or antagonist treatment), and subjects receiving GnRH analogue or
antagonist must continue this treatment throughout the time on this study

- Patients may have been treated previously with a nonsteroidal antiandrogen, with
evidence of disease progression subsequently; subjects must be off use of
anti-androgen for at least 4 weeks (for flutamide) or 6 weeks (for bicalutamide
or nilutamide) prior to registration

** Subjects who demonstrate an anti-androgen withdrawal response, defined as a >=
25% decline in PSA within 4-6 week of stopping a nonsteroidal antiandrogen are
not eligible until the PSA rises above the nadir observed after antiandrogen
withdrawal

- Castration levels of testosterone (< 50 ng/dL) within 2 weeks of registration

- Progressive disease while receiving androgen deprivation therapy defined by any one of
the following as per the Prostate Cancer Clinical Trials Working Group 2 (PCWG2) bone
scan criteria or Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 during or
after completing last therapy:

- PSA: at least two consecutive rises in serum PSA, obtained at a minimum of 1-week
intervals, and each value >= 2.0 ng/mL

- Measurable disease: >= 50% increase in the sum of the cross products of all
measurable lesions or the development of new measurable lesions; the short axis
of a target lymph node must be at least 15 mm by spiral CT to be considered a
target lesion

- Non-measurable (bone) disease: the appearance of two or more new areas of uptake
on bone scan consistent with metastatic disease compared to previous imaging
during castration therapy; the increased uptake of pre-existing lesions on bone
scan will not be taken to constitute progression, and ambiguous results must be
confirmed by other imaging modalities (e.g. X-ray, CT or magnetic resonance
imaging [MRI])

- Must have >= 3 serum PSA values obtained over at least a 12 week period of time prior
to registration, including the day of screening, to calculate a PSA doubling time;
Note: PSA's are not required to be obtained at the same laboratory; use all PSA values
that have been done in last 6 months to calculate PSA doubling time

- Life expectancy of at least 6 months

- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of
0, 1, or 2

- White blood cell >= 2000/mm^3

- Absolute neutrophil count >= 1000/mm^3

- Hemoglobin (HgB) >= 9.0 mg/dL

- Platelets >= 100,000/mm^3

- Creatinine =< 2.0 mg/dL

- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =< 2.5 x
institutional upper limit of normal

- Negative serology tests for human immunodeficiency virus (HIV) 1 and 2, and for active
hepatitis B or hepatitis C, within 14 days of first peripheral blood collection for
sipuleucel-T

- Patients must be at least 4 weeks from any prior treatments and have recovered (to <
grade 2) from acute toxicity attributed to this prior treatment

- Patients must be informed of the experimental nature of the study and its potential
risks, and must sign an Institutional Review Board (IRB)-approved written informed
consent form indicating such an understanding

Exclusion Criteria:

- Small cell or other variant prostate cancer histology

- Patients may not be receiving other investigational agents or be receiving concurrent
anticancer therapy other than androgen deprivation

- Symptomatic metastatic disease, as defined by the need for opioid analgesics for the
treatment of pain attributed to a prostate cancer metastatic lesion; patients
receiving opioids must receive approval from the principal investigator (PI) for
eligibility

- Patients may not have been treated with prior sipuleucel-T

- Treatment with any of the following medications within 28 days of registration, or
while on study, is prohibited:

- Systemic corticosteroids (at doses over the equivalent of 1 mg prednisone daily);
inhaled, intranasal or topical corticosteroids are acceptable

- Prostate cancer (PC)-SPES

- Saw palmetto

- Megestrol

- Ketoconazole

- 5-alpha-reductase inhibitors-patients already taking 5-alpha-reductase inhibitors
prior to 28 days prior to registration may stay on these agents throughout the
course of therapy, but these should not be started while patients are on study

- Diethyl stilbestrol

- Abiraterone

- Any other hormonal agent or supplement being used with the intent of cancer
treatment

- External beam radiation therapy within 4 weeks of registration is prohibited, or
anticipated need for radiation therapy (e.g. imminent pathological fracture or spinal
cord compression) within 3 months of registration

- Major surgery within 4 weeks of registration is prohibited

- Prior cytotoxic chemotherapy (e.g. docetaxel, mitoxantrone, cabazitaxel) within 6
months of registration is prohibited

- Patients with a history of life-threatening autoimmune disease

- Patients who have undergone splenectomy

- Patients must not have other active malignancies other than non-melanoma skin cancers
or carcinoma in situ of the bladder; subjects with a history of other cancers who have
been adequately treated and have been recurrence-free for >= 3 years are eligible

- Patients with known brain metastases

- Any antibiotic therapy or evidence of infection within 1 week of registration

- Any other medical intervention or condition, which, in the opinion of the PI could
compromise patient safety or adherence with the study requirements

- Patients cannot have concurrent enrollment on other phase I, II, or III
investigational treatment studies