A Phase 1 Study To Evaluate Escalating Doses Of A Vaccine-Based Immunotherapy Regimen For Prostate Cancer (PrCa VBIR)

Inclusion Criteria:

- Histological or cytological diagnosis of prostate cancer

- Adequate bone marrow, kidney and liver function

- Hormone sensitive relapsing prostate cancer after definitive local therapy
(biochemical relapse) OR

- Progressive disease post-surgical castration or during androgen suppression therapy
(pre-secondary hormone CRPC) OR

- Failed prior therapy with a secondary hormone (e.g. enzalutamide, abiraterone) with
documented progressive disease (post-secondary hormone CRPC)

Exclusion Criteria:

- ECOG performance status greater than or equal to 2

- Concurrent immunotherapy for prostate cancer

- History of or active autoimmune disorders (including but not limited to: myasthenia
gravis, thyroiditis, pneumonitis, rheumatoid arthritis, multiple sclerosis, systemic
lupus erythematosus, scleroderma) and other conditions that disorganize or alter the
immune system.

- History of inflammatory bowel disease.

- Current use of any implanted electronic stimulation device

- For biochemically relapsed patients, no concurrent use of ADT or orchiectomy and no
known prior or current evidence of any metastatic involvement of distant organs

- For pre-secondary hormone patients, no prior or concurrent treatment with a secondary
hormone (e.g. enzalutamide, abiraterone)

- For post-secondary hormone patients, no concurrent treatment with a secondary hormone
(e.g. enzalutamide, abiraterone), no metastasis to the liver or brain