National Cancer Institute (NCI)
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.
Background: * Biochemical recurrence (BCR) denotes rising prostate serum antigen (PSA) and negative computed tomography (CT) and Tc99 bone scan following radical prostatectomy and/or definitive local radiation. * Beyond local salvage radiation options, the management of BCR has not been clearly defined. * As BCR is an asymptomatic stage of disease which can take years to progress to overt metastatic disease, treatment for this stage should have minimal side effects and only be for a limited duration of time. * The advent of prostate-specific membrane antigen (PSMA)-based imaging has driven st…
* INCLUSION CRITERIA: * 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 radioth…
15 mg/kg subcutaneous on Day 1 of every 3-week cycle for up to 8 cycles
The 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
Single IV dose of 18F-DCFPyL by bolus injection. The target administered activity will be 6.5 mCi with a lower limit of 6 mCi