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.
Parallel
N-803
Drug15 mg/kg subcutaneous on Day 1 of every 3-week cycle for up to 8 cycles
ETBX-71 Vaccine
DrugThe dose to be injected is 5(SqrRoot) 10\^11 viral particles (VP) per 1 mL. Injected subcutaneously on Day 1 of every 3-week cycle for a total of up to 8 cycles
18F-DCFPyL
RadiationSingle IV dose of 18F-DCFPyL by bolus injection. The target administered activity will be 6.5 mCi with a lower limit of 6 mCi
Efficacy of N-803 alone or with ETBX-071 vaccine
PSA30 response- defined as a \>= 30% reduction in PSA from PSA at C1D1 of immunotherapy (comparing C1D1 PSA to timepoints during and after immunotherapy). The fractions with PSA30 response will be reported along with a 95% confidence interval, separately for the two randomized treatment groups.
Duration of PSA50 response
Duration of PSA response will be evaluated using the Kaplan-Meier method unless all participants are identified as having an end to their response (no censoring). The median duration of PSA response will be reported, starting at the date the PSA30 response was identified, along with a 95% confidence interval for the median, separately for the two randomized treatment groups.
Time to PSA progression
Time to PSA progression after immunotherapy will be evaluated using the Kaplan-Meier method unless all participants are identified as having an end to their response (no censoring). The median time to PSA progression will be reported, starting at the date Cycle 1 began, along with a 95% confidence interval for the median.
PSA doubling timing
PSA doubling time at randomization, compared to PSA doubling time at the end of treatment (EOT) visit.
Proportion of participants with 30% PSA decline receiving immunotherapy treatment after SBRT
The median changes in PSA doubling time (in months) will be determined separately for both treatment groups with paired differences compared within participants using a Wilcoxon signed rank test.
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