Inclusion Criteria for a Randomized Trial of Second-Line Therapy in Hormone Refractory Prostate Cancer
INCLUSION CRITERIA:
Signed & dated written informed consent obtained from the subject by w/local regulations.
Histologically confirmed conventional and/or mucinous adenocarcinoma of the prostate. If histological confirmation is not available, cytological confirmation will be permitted in lieu.
Must meet one of the following 3 criteria for progressive disease following androgen deprivation:
A. Subjects w/nodal or visceral metastases:
Must have progressive disease defined by RECIST criteria or defined by the Prostate Cancer Clinical Trials Working Group II (Scher et al. 2008).
B. Subjects w/no measurable disease:
PSA only disease must have an elevated PSA as defined by Consensus Criteria Prostate Cancer Clinical Trials Working Group II (Scher et al. 2008). PSA must indicate progressive disease defined as rising PSA values, at least 7 days apart, >2 ng/mL in the 28 days prior to randomization.
C. Subjects w/bone involvement:
New disease on bone scan as defined by Consensus Criteria Prostate Cancer Clinical Trials Working Group II (Scher et al. 2008). 4. Subjects on stable dose of bisphosphonates showing subsequent tumor progression may continue on this medication; however, subjects are not allowed to initiate bisphosphonate therapy w/in 28 days prior to starting study treatment at Week 1 or at any time after that during the study, 5. Must be clinically immunocompetent. Clinical immunocompetence assumed unless subject has been diagnosed as immunosuppressed, is receiving immunosuppressive chemotherapy for oncology disorders, or is receiving immunosuppressive therapy following transplant, in which case they will be excluded.
6. Subject free of clinically apparent/active autoimmune disease (no prior confirmed diagnosis or treatment for autoimmune disease including Systemic Lupus Erythematosis, Grave’s Disease, Hashimoto’s Thyroiditis, Multiple Sclerosis, & Rheumatoid Arthritis).
7. Subject has adequate bone marrow function defined by Absolute Lymphocyte Count (ALC) ≥ 500/µL, Absolute Neutrophil Count (ANC) >1200/µL, Platelet Count >100,000/µL.
8. Subject has peripheral neuropathy grade ≤1. 9. Subject has ECOG status of 0 or 1. 10. Minimum life expectancy ≥6 months. 11. Progressive disease (as defined above) must be documented after discontinuation of the hormonal and anti-androgen therapy.
12. Subject continues to stay on medical treatment such as LHRH agonists or LHRH antagonists to maintain testosterone value of <50ng/dL.