| Eligibility |
Inclusion Criteria:
1. Consent to MD Anderson laboratory protocol PA13-0291.
2. Histological documentation of adenocarcinoma of the prostate reviewed at MD Anderson
Cancer Center. Patients with small cell, neuroendocrine, or transitional cell
carcinomas are not eligible.
3. Patients with high-risk prostate cancer (at least 1 core with Gleason sum >/=8) must
have at least three core biopsies involved with cancer (a minimum of 6 core biopsies,
must be obtained at baseline). A prostate biopsy within 3 months from screening is
allowed for entry requirements.
4. No evidence of metastatic disease as documented by technetium-99m (99mTc) bone scan
and by computed tomography (CT) or magnetic resonance imaging (MRI) scans.
5. Eugonadal state (serum testosterone >150 ng/dL).
6. Localized or locally advanced disease deemed by the surgeon to be resectable. Patients
must be appropriate candidates for radical prostatectomy plus pelvic lymph node
dissection.
7. No prior treatment for prostate cancer including prior surgery (excluding
transurethral resection of the prostate [TURP]), cryoablation, pelvic lymph node
dissection, radiation therapy, hormonal therapy or chemotherapy.
8. Subject must be a man age >/= 18 years of age.
9. To avoid risk of drug exposure through the ejaculate (even men with vasectomies),
subjects must use a condom during sexual activity while on study drug and for 3 months
following the last dose of study drug. If the subject is engaged in sexual activity
with a woman of childbearing potential, a condom is required along with another
effective contraceptive method consistent with local regulations regarding the use of
birth control methods for subjects participating in clinical studies and their
partners. Donation of sperm is not allowed while on study drug and for 3 months
following the last dose of study drug.
10. ECOG performance status (PS) grade of 0 or 1.
11. Clinical laboratory values at screening: a) Hemoglobin, platelet count, absolute
neutrophil count, absolute lymphocyte count within institutional normal limits.
Administration of growth factors or blood transfusions will not be allowed to confirm
eligibility b) Serum chemistries, renal and liver panels within institutional normal
limits or requirements for radical prostatectomy
12. Each subject must sign an informed consent form (ICF) indicating that he understands
the purpose of and procedures required for the study and is willing to participate in
the study.
Exclusion Criteria:
1. Prior hormone therapy for prostate cancer including orchiectomy, antiandrogens,
ketoconazole, or estrogens (5-alpha reductase inhibitors allowed), or LHRH
agonists/antagonists.
2. Currently enrolled in another interventional study.
3. Concurrent treatment with systemic corticosteroids (prednisone dose >10 mg per day or
equivalent) or other immunosuppressive drugs <14 days prior to treatment initiation.
Steroids that are topical, inhaled, nasal (spray), or ophthalmic solution are
permitted.
4. History of or known or suspected autoimmune disease (exception(s): subjects with
vitiligo, resolved childhood atopic dermatitis, hypothyroidism, or hyperthyroidism
that is clinically euthyroid at screening are allowed).
5. Known evidence of an active infection requiring systemic therapy such as human
immunodeficiency virus (HIV), active hepatitis, or fungal infection.
6. History of clinically significant cardiovascular disease including, but not limited
to: a) Myocardial infarction or unstable angina </= 6 months prior to treatment
initiation b) Clinically significant cardiac arrhythmia c) Deep vein thrombosis,
pulmonary embolism, stroke </= 6 months prior to treatment initiation d) Congestive
heart failure (New York Heart Association class III-IV) e)Pericarditis/clinically
significant pericardial effusion f) Myocarditis g) Endocarditis
7. History of major implant(s) or device(s), including but not limited to: a) Prosthetic
heart valve(s) b) Artificial joints and prosthetics placed </= 12 months prior to
treatment initiation c) Current or prior history of infection or other clinically
significant adverse event associated with an exogenous implant or device that cannot
be removed
8. Other prior malignancy (exceptions: adequately treated basal cell or squamous cell
skin cancer, superficial bladder cancer, or any other cancer in situ currently in
complete remission) </= 2 years prior to enrollment.
9. Any condition that in the opinion of the investigator, would preclude participation in
this study.
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