Study on Combining Nivolumab Immunotherapy with Radiation and Hormone Therapy for Prostate Cancer

Inclusion Criteria

• Must provide signed and dated consent to participate.
• Willing to follow all study procedures and be available for the study duration.
• Male, aged 18 years or older.
• In good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Diagnosed with high-grade prostate cancer (Gleason grade 9 or 10) with more than 30% of biopsy samples involved.
• Undergoing first-line treatment for prostate cancer.
• Have a biopsy sample available.
• Have limited metastatic disease (3 or fewer sites) and are being treated with the intent to cure.
• Eligible for radiation therapy and short-term hormone therapy.
• Receiving radiation treatment at Moffitt Cancer Center.
• Normal organ function as defined in the study protocol.
• Men who are sexually active with women of childbearing potential must agree to use effective contraception during treatment and for 31 weeks after completing treatment. Men must also agree not to donate sperm during this time.

Exclusion Criteria

• Have autoimmune diseases like inflammatory bowel disease, rheumatoid arthritis, or lupus, except for certain conditions like Hashimoto's thyroiditis.
• Require systemic treatment with corticosteroids or other immunosuppressive medications within 14 days of starting the study.
• Have had prior therapy with certain immune-targeting drugs.
• Have symptomatic lung disease or conditions that could interfere with treatment.
• Have had other cancers unless in complete remission for at least 2 years.
• Have medical conditions that could increase risks or interfere with the study.
• Have had major surgery or significant injury not fully recovered from within 14 days before starting radiation therapy.
• Test positive for hepatitis B or C, or have a history of HIV/AIDS.
• Have inadequate blood, liver, or pancreatic function.
• Have allergies to any study drugs or components.
• Have uncontrolled illnesses or social situations that could affect study participation.