Study on 2141-V11 Combined with Standard Treatments for Prostate Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
ClinicalTrials ID:NCT06347705
This clinical trial is exploring whether adding a new drug, 2141-V11, to standard prostate cancer treatments can effectively eliminate cancer. The study will also check for any remaining cancer cells after treatment.
Patient Parameters
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Program Overview
The aim of this study is to test if combining the new drug 2141-V11 with standard treatments can effectively treat prostate cancer. 2141-V11 helps the immune system find and destroy cancer cells. Researchers will see if this approach can completely remove cancer and check for any minimal residual disease (MRD), which means a small number of cancer cells left in the body after treatment.
Eligibility Criteria
Inclusion Criteria
- Must be willing to provide written consent and allow the use of health information for research.
- Male, aged 18 years or older.
- Have a testosterone level of at least 150 ng/dL (for certain groups), unless currently on hormone therapy.
- Have good bone marrow, liver, and kidney function based on recent blood tests.
- Have a clinical assessment of prostate cancer stage by a doctor within the last 90 days.
- Be a candidate for prostate surgery with lymph node removal.
- Agree to use condoms and another form of birth control if having sex with a woman who can become pregnant, and not donate sperm during the study and for 3 months after.
- Have a detectable prostate lesion on an MRI scan.
Exclusion Criteria
- Have had previous prostate surgery, radiation, or other treatments for prostate cancer.
- Currently on hormone therapy started more than 8 weeks before the study.
- Have had chemotherapy or experimental treatments for prostate cancer recently.
- Have known cancer spread to the brain, liver, lungs, or other organs (except certain lymph nodes).
- Have another active cancer or a history of cancer within the last 5 years, except for certain skin or early-stage cancers.
- Have a significant medical condition that would make participation unsafe, such as:
- Need for high-dose steroids.
- Active infection needing treatment.
- Uncontrolled high blood pressure.
- Liver or kidney problems.
- HIV with certain conditions.
- Heart disease or recent heart attack.
- History of seizures or conditions that may cause seizures.
- Inflammatory bowel disease.
- Taking medications that could interfere with the study treatment.
- Known allergies to certain prostate cancer medications.
- Unable to undergo an MRI scan.
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