Background:
Prostate cancer is the second most common cause of cancer-related death among men in the United States. Early-stage, low-grade prostate cancer is managed with active monitoring. However, 35% of men with this cancer will need treatment within 5 years because of tumor growth. Researchers want to know if a new vaccine that targets 3 anti-cancer proteins (TriAdeno) plus a drug (N-803) approved for bladder cancer can help stop prostate tumors from growing.
Objective:
To test TriAdeno and N-803 in people with early-stage prostate cancer.
Eligibility:
People aged 18 years and older with early-stage low- or medium-risk prostate cancer.
Design:
Participants will be screened. They will have a physical exam with blood tests. They will have a test of their heart function. They will have an imaging scan. They may have a rectal exam.
TriAdeno is injected under the skin of the upper thigh; N-803 is injected under the skin of the abdomen. Participants will be treated in up to four 21-day cycles. They will get both injections on the first day of each cycle.
Participants may opt to complete a memory aid: They may record all of their symptoms for 7 days after each injection. They may also complete a questionnaire about their prostate symptoms.
Blood tests, imaging scans, and other tests will be repeated during the study.
A tissue sample (biopsy) of the tumor will be collected during or after cycle 2; a second biopsy may be taken about 1 year later.
Participants will have follow-up phone calls for 5 years....
Histologically confirmed diagnosis of organ confined, low- or intermediate-risk PCa (Gleason grade group 1 or 2) identified in at least one prostate biopsy core. Biopsies performed at outside institutions should have Gleason score confirmed at the NCI by a genitourinary (GU) pathologist.
Participants must be on active surveillance.
Pre-study treatment tissue availability (at least one formalin-fixed paraffin embedded [FFPE] biopsy core or one H and E-stained slide and at least 5 unstained slides) obtained between 3 and 24 months prior to treatment initiation is mandatory for study initiation.
Serum PSA level of <20 ng/mL (or <10ng/mL for participants being treated with 5- alpha-reductase inhibitors)
Prior treatment for PCa by surgery, radiation, local ablative (i.e., cryosurgery or highintensity focused ultrasound), or androgen-deprivation therapy.
Evidence of PCa with metastatic disease.
Prior treatment with adenovirus-based vector immunotherapy, adenovirus-based vaccines, or investigational vaccines.
Prior solid organ or bone marrow transplant.
Single group
TriAdeno vaccine
Biological/VaccineThe TriAdeno vaccine will be administered on Day 1 of every 21-day cycle for up to 4 cycles.
N-803
DrugN-803 will be administered on Day 1 of every 21-day cycle for up to 4 cycles.
To determine the effect of TriAdeno vaccine with N-803 on immune infiltration of the local tumor environment
Change in the density of T-cell immune infiltrates in the malignant portions of prostate using a paired two sample t-test
To assess the adverse events associated with TriAdeno vaccine and N-803
Toxicities will be reported in a descriptive fashion per type, frequency, and grade
To determine the effect of the TriAdeno vaccines with N-803 on the change in PSA
Change in PSA will be analyzed using a paired two sample t-test.
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This trial is not recruiting at the moment. You can still explore other options: