This phase 2 study will investigate cryosurgical freezing (CF) and intratumoral combination immunotherapy (ITI) in advanced prostate cancer (PC). The main outcome will be the reduction in prostate specific antigen (PSA). This trial is recruiting in California and Michigan, US.
Metastatic prostate cancer (PC) is an advanced cancer. Metastatic is the term for cancer that has spread to other organs. Radiotherapy (RT) and chemotherapy (CT) may prolong survival. Better treatment strategies are needed to improve patient outcomes. Cryosurgical freezing (CF) and intratumoral combination immunotherapy (ITI) may be one option.
CF involves freezing the tumor. The cancer cells on the outside of the tumor die and break off. This triggers a type of immune cell called dendritic cell. In theory, these cells will recruit other immune cells called T-cells. T cells will travel in the bloodstream to kill other cancer cells. To kill the primary tumor, ITI can be used. Immune checkpoint inhibitor (ICI) drugs can be injected into the tumor and prevent cancer cells from growing undetected by immune cells. Immune cells will attack the cancer cells and stop tumor growth.
This study will investigate CF and ITI in advanced PC. The main outcome will be the reduction in PSA.
Who are they looking for?
This study will recruit 32 patients with metastatic PC. Participants must have a minimum life expectancy of 6 months. Patients must provide a tumor sample for analysis, if they have a previous biopsy. Patients must have adequate blood tests. Men must use contraception during and for 120 days after the trial.
Patients cannot part in the trial if they have taken part in another study with an experimental drug. Patients with a history of active infection or immunodeficiency cannot take part in the trial. Men with autoimmune disease cannot take part. Other exclusion criteria are heart disease, unstable heart conditions, recent live vaccination or sensitivity to study treatment.
How will it work
All patients will undergo CF and ITI. The ICI drugs used are nivolumab (Opdivo) and ipilimumab (Yervoy). A low dose of a CT drug, cyclophosphamide (Cytoxan),will also be administered. This is to enhance the response of specific types of tumor cells.
The main outcome will be the reduction in PSA after 6 months. Patients will be followed up for survival for up to 3 years.