NCT07574541
Multitargeted Recombinant Ad5 PSA/MUC-1/Brachyury-Based Immunotherapy (TriAdeno) Vaccine With IL-15 Superagonist N-803 in Participants With Clinically Localized Prostate Cancer Undergoing Active Surveillance
레지스트리 요약
- 진행 상태
- 모집 전 (NOT_YET_RECRUITING)
- 질환/조건
- Adenocarcinoma, Prostate Cancer, Neoplasms, Carcinoma, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type
- 시험 유형
- 중재 연구 (INTERVENTIONAL)
- 단계
- Phase 2
- 목적
- 치료
- 중재 유형
- 생물학적 제제, 약물
- 개입·치료
- TriAdeno vaccine, N-803
- Lead Sponsor
- National Cancer Institute (NCI) (NIH)
캐시 시각: 2026-07-23 09:52:50
요약
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....
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....
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