Background:
Biochemically recurrent prostate cancer (BCR) occurs when prostate-specific antigen (PSA) levels in the blood rise after surgery or radiation. BCR affects 30,000 to 50,000 men each year. Researchers want to know if a drug (N-803) alone or combined with a vaccine (ETBX-071) can reduce PSA in BCR prostate cancer after radiation.
Objective:
To test a study drug alone and combined with a vaccine in people with BCR prostate cancer who have been treated with targeted radiation to areas of recurrent prostate cancer in the past.
Eligibility:
People aged 18 years and older with BCR prostate cancer who have previously undergone treatment with stereotactic body radiation therapy (SBRT).
Design:
Participants will be screened. They will have a physical exam with blood tests. They will have tests of their heart and kidney function. They will have 3 different imaging scans of their tumors.
N-803 is injected under the skin of the abdomen. ETBX-071 is injected under the skin of thigh.
Participants will be divided into 2 groups: 1 group will get N-803 alone; 1 group will get both N-803 and ETBX-071.
The drug or drugs will be given on the first day of 21-day treatment cycles. Participants will have 8 treatment cycles.
Participants will have a follow-up visit 3 weeks after their last dose of the study drugs. Blood tests and all 3 imaging scans will be repeated.
Follow-up visits will continue every 4 to 8 weeks for 5 years. These visits will include a positron emission tomography (PET) scan every 6 months.
Histopathological confirmation of prostate adenocarcinoma by the Laboratory of Pathology at the National Institutes of Health (NIH) Clinical Center prior to the study treatment initiation. If no pathologic specimen is available, participants may enroll with a pathologist s report showing a histologic diagnosis of prostate adenocarcinoma and a clinical course consistent with the disease from any outside site.
Biochemically recurrent prostate cancer, defined as PSA over 0.8 ng/ml following radical prostatectomy or >= 2 ng/ml above the nadir following definitive radiotherapy or definitive radiotherapy (including brachytherapy) for localized prostate cancer.
Participants must be at least 1 year removed from definitive local therapy before the study treatment initiation.
Recovery to baseline from acute toxicity related to prior therapy, including surgery and radiation.
Human immunodeficiency virus (HIV) seropositivity
HBV or HCV seropositivity
Other immunodeficiency diseases
Active autoimmune diseases such as Addison's disease, Hashimoto's thyroiditis, systemic lupus erythematosus, Sjogren syndrome, scleroderma, myasthenia gravis, Goodpasture syndrome or active Grave's disease. Participants with a history of autoimmunity that has not required systemic immunosuppressive therapy or does not threaten vital organ function including central nervous system (CNS), heart, lungs, kidneys, skin, and gastrointestinal (GI) tract will be allowed. Participants with diabetes type I, vitiligo, or alopecia are allowed.
National Cancer Institute (NCI)
Lead sponsor