Prostate Cancer Vaccines
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Immunomodulatory DC vaccines to target prostate cancer.
- Who it may be relevant to
- Registry conditions: Prostate Cancer Indications. Basic parameters: 18 years — 80 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Development of Prostate Cancer Dendritic Cell Vaccines
Overview
Tumor antigens are protein fragments produced by cancer cells carrying genetic mutations, and many tumor antigens are similar to normal protein antigens, making them unrecognizable by the immune system. Many tumor vaccines are prepared based on a single tumor antigen. This study is based on multiple target antigens using tumor lysates or synthetic peptides. The immune modulation by dendritic-cell (DC)-based cancer vaccines consists of genetically modified DCs to activate T cells to target cancer cells. The study is based on an advanced cancer vaccine technology, which aims to evaluate the safety and potential benefit of the novel immunomodulatory prostate cancer DC vaccines.
Detailed description
Prostate cancer is a malignancy originating from the epithelial cells of the prostate gland, ranking as the second most common cancer among men worldwide. Its etiology involves factors such as genetics, age, lifestyle (e.g., high-fat diet, obesity), and hormone levels. High-risk populations are typically men aged 45 and above.
Prostate cancer vaccines based on multiple target antigens derived from tumor lysates or synthetic peptides can serve as antigenic targets for immune cells. The vaccines involve immunomodulation with autologous DCs to stimulate and activate T cells in the body to target cancer cells. The principle of the DC vaccines is simple: to harness and enhance the body's anti-cancer immunity. The process involves simulating antigen-presenting cells with target tumor antigens in culture and then injecting patients with the modified antigen-presenting DCs. Early studies of DC-based vaccines targeting prostate cancer have shown high safety and low toxicity. Here, the study aims to evaluate the safety and efficacy of prostate cancer DC vaccines that use multiple target antigens based on prostate cancer cells to stimulate and induce a specific and strong anti-cancer immune response.
Interventions
- Biological Immunomodulatory DC vaccines to target prostate cancer
1 to 2 injections, with an interval of one month, of 1\~2x10\^7 DC vaccine administered subcutaneously
Primary outcome measures
- Events of adverse effects after the DC vaccine injection [Time frame: up to one month]
Secondary outcome measures (4)
- Rate of successful prostate cancer DC vaccine generation [Time frame: up to one month]
- Ability of prostate cancer DC vaccines to induce anti-cancer reaction [Time frame: after 1 month from prostate cancer DC injection to 12 months after injection]
- Ability of prostate cancer DC vaccines to induce an anti-cancer reaction [Time frame: after 1 month from prostate cancer DC injection to 24 months after injection]
- Ability of prostate cancer DC vaccines to induce an anti-cancer reaction [Time frame: after 1 month from prostate cancer DC injection to 24 months after injection]
Eligibility criteria
Inclusion criteria
- Histologically confirmed adenocarcinoma of the prostate
- ECOG performance status 0-1
- Life expectancy ≥ 12 weeks
- WBC ≥ 3,500/µL
- Platelet count ≥ 100,000/µL
- Hemoglobin ≥ 10.0 g/dL
- Creatinine ≤ 2.0 mg/dL
- Alkaline phosphatase ≤ 2.5 times upper limit of normal (ULN)
- AST ≤ 2.5 times ULN
- Fertile patients must use effective contraception
- Willing to provide blood samples for research purposes
- Able to complete questionnaire(s) alone or with assistance
- Able to undergo leukapheresis
- No known immunodeficiency
- No other malignancy within the past 5 years except for basal cell or squamous cell carcinoma of the skin treated with local resection only
- No concurrent serious illness
- No known history of positive PPD skin test
- Human immunodeficiency virus (HIV) and Hepatitis C virus (HCV) test negative.
Exclusion criteria
- The patient was still using dexamethasone at a dose greater than 4 mg/day during mononuclear cell collection
- Patients have a history of autoimmune diseases or other diseases requiring long-term use of hormones or immunosuppressive drugs
- Patients with a history of allergies or allergies to immune cells and adjuvants of cellular products
- Active infection with fever
- Patients with neutropenia (> 10 days) that are difficult to correct after treatment
- Infection with bacteria, fungi or viruses, uncontrolled
- Patients with HIV and those living with active HBV and HCV
- Severe organ failure (heart, liver, kidney, lung)
- Patients who had previously been treated with cell therapy products and examined by team experts deemed not suitable for treatment
- Anything that researchers believe may increase the risk of subjects or interfere with test results
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shenzhen Geno-immune Medical Institute — Shenzhen
Identifiers
NCT: NCT07068555 · GIMI-IRB-25002