This study evaluates the effectiveness of an immunotherapy in the treatment of newly diagnosed prostate cancer. The main outcome to be measured in this trial is the number of patients whose cancer does not progress within 3 years after immunotherapy injection. This trial is taking place in many sites across the USA.
Prostate cancer can be treated by medication, surgery or radiation. Medication aims to kill prostate cancer cells chemically. Surgery aims to cut out the cancerous prostate tissue. Radiation therapy uses radio waves to kill the cancerous prostate tissue. Immunotherapy can also be used. Sipuleucel-t (Provenge) is a type of injected immunotherapy. Sipuleucel-t is programmed to the patient's own immune system. This allows it to activate the immune system and cause it to attack the cancer cells.
This trial evaluates if treatment with sipuleucel-t can slow cancer progression. The main outcome to be measured is the number of patients whose cancer does not progress after treatment.
Who are they looking for?
This trial is looking for 450 participants. To be included in this study, patients must be diagnosed with prostate cancer within 12 months of the trial. Patients must be suitable for surgery or radiation therapy if prostate cancer progresses. Patients must have adequate liver, kidney, and blood cell counts.
Patients cannot have used a type of drug called 5 alpha reductase inhibitors such as finasteride (Proscar) or dutasteride (Avodart) continuously for 6 months or more or have taken them within 6 months of the study. Patients cannot have a history of any other cancer or of brain vessel disease (including stroke). Patients must not have used any herbal, dietary or alternative anti-cancer therapy (such as saw palmetto, ketoconazole) within 30 days of the study. The study doctors will confirm whether herbal remedies are classed as prohibited. Patients cannot be on treatments that block the immune system (such as glucocorticoids). Patients cannot have uncontrolled medical conditions such as active infections, heart failure or unstable angina, or psychiatric illnesses. Patients must not have low testosterone levels or be on continuous testosterone replacement therapy.
How will it work
Patients will be randomly assigned to two groups. Group 1 will receive 3 sipuleucel-t injections (into the vein) at 2-week intervals. Group 2 will receive active surveillance. Patients will have a follow-up visit every 6 months. Patients will be followed up to 3 years.
The main outcome to be measured will be the number of patients who do not have tumor growth within 3 years.