A Phase 1/Phase 2 Trial to Evaluate Safety, Immunogenicity and PSA Response of VTP-850 Prostate Cancer Immunotherapeutic in Men with Biochemical Recurrence after Definitive Local Therapy for Prostate Cancer
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The purpose of this study is to determine how safe the study drug, VTP-850, is in people with prostate cancer who have had initial treatment but their prostate-specific antigen (PSA) levels have started to rise again. This study also aims to find the appropriate dose regimen of VTP-850 that can be given safely to people with prostate cancer. In addition, we want to see if VTP-850 brings about an immune response and if it has an effect on prostate cancer. VTP-850 is considered immunotherapeutic investigative drug, which means that it is meant to work by stimulating a person’s immune system to react against their prostate cancer and kill prostate cancer cells. VTP-850 is an investigational vaccine for prostate cancer which means the study drug is not approved by Health Authorities including the United States Food and Drug Administration (FDA) for the treatment of prostate cancer. This will be the first time that VTP-850 will be given to humans
Are you Eligible? (Inclusion Criteria)
- Are you 18 years or older and male? - Have you undergone primary therapy for prostate cancer (radical prostatectomy(surgery to remove the entire prostate and some of the tissue around it, including the seminal vesicles (a gland that helps make semen)) and/or definitive external beam radiation(type of radiation therapy that uses a machine to aim high-energy rays at the cancer from outside of the body) and/or brachytherapy(type of radiation therapy in which radioactive material sealed in needles, seeds, wires, or catheters is placed directly into or near a tumor)) - Are you not planning to start ADT (androgen deprivation therapy- suppresses or block the production or action of male hormones. This is done by having the testicles removed, by taking female sex hormones, or by taking drugs called antiandrogens) for at least 4 months after Day 1 of starting this investigational drug, VTP-850? - Do you have an Eastern Cooperative Oncology Group (ECOG) score (measures functional status) of 0 or 1?
