Enzalutamide in Combination With PSA-TRICOM in Patients With Non-Metastatic Castration Sensitive Prostate Cancer
- Enzalutamide is a well tolerated hormone therapy that is used to treat advanced prostate cancer. It is given to help kill cancer cells and limit cancer cell growth. A new possible way of treating prostate cancer is using a therapeutic cancer vaccine (immune stimulating therapy) that may help activate the immune system against the cancer. The immune stimulating vaccine will help white blood cells recognize and kill the cancer cells throughout the body. This vaccine therapy has been tested in hundreds of patients and is very well tolerated. Researchers want to see whether this vaccine, given with enzalutamide, is more effective at treating advanced prostate cancer than enzalutamide alone.
- To compare the safety and effectiveness of enzalutamide with and without vaccine therapy for advanced prostate cancer.
- Men at least 18 years of age who have advanced castration sensitive prostate cancer.
- Patients must have testosterone within the normal range
- No evidence of metastatic prostate cancer on CT or Bone scan
- No history of autoimmune diseases
- No previous immunotherpy within 3 years
- Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Imaging studies will be used to monitor the cancer before treatment.
- Participants will be separated into two groups. One group will have enzalutamide and the study vaccine. The other group will have enzalutamide alone.
- All participants will take enzalutamide once a day. They will take the drug for 3 months. This form of intermittent therapy is common in this population of patients.
- The vaccine group of participants will receive the new study vaccine. They will have a single injection on the first day of the first study cycle. There will be regular booster injections afterward. There will be one injection during the third week of treatment, and one in the fifth week. The vaccine will then be given every 4 weeks until 21 weeks have passed.
- Treatment will be monitored with frequent blood tests and imaging studies.
Drug: Enzalutamide (Xtandi)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Enzalutamide in Combination With PSA-TRICOM in Patients With Non-Metastatic Castration Sensitive Prostate Cancer|
- Decrease in tumor re-growth rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Immune response [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Determine impact on PSA [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Experimental: Arm A
Enzalutamide for 3 months
Drug: Enzalutamide (Xtandi)
An androgen receptor inhibitor.
Experimental: Arm B
Enzalutamide 3 months + PSA-TRICOM on weeks 1, 3, 5, 9,13,17 and 21
A recombinant fowlpox virus vector vaccine containing the genes for human PSA and three co-stimulatory molecules.Biological: PROSTVAC-V/TRICOM
A recombinant vaccinia virus vector vaccine containing the genes for human PSA and three co-stimulatory molecules.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01875250
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Ravi A Madan, M.D.||National Cancer Institute (NCI)|