Study on SYNC-T Therapy SV-102 for Men with Advanced Prostate Cancer

Inclusion Criteria

• Men aged 18 and older.
• Able to understand and agree to the study requirements.
• Have advanced prostate cancer that has spread and is confirmed by lab tests.
• Low testosterone levels if on hormone therapy.
• Cancer has worsened after trying other treatments, including hormone therapy and possibly chemotherapy.
• Able to have anesthesia or sedation.
• Recent heart check-up and clearance.
• Good general health with a performance status of less than 3.
• Expected to live at least 6 more months.
• Last cancer treatment (except hormone therapy) was at least 28 days ago.
• Any side effects from previous treatments have resolved.
• Men with partners who can become pregnant must use effective birth control during and after the study.
• Have a tumor that can be measured and accessed for treatment.
• Stable on bone-strengthening therapy if applicable.
• No other effective treatment options available or chosen.
• Good bone marrow, kidney, and liver function.
• Willing to provide a tumor sample and undergo a biopsy during the study.

Exclusion Criteria

• Have another active cancer needing treatment in the last 3 years, except for certain skin or thyroid cancers.
• Blocked urinary system.
• Recent major surgery or prostate intervention.
• Use of blood thinners before the study.
• Active infection needing treatment.
• History of lung inflammation needing steroids.
• Recent live vaccine.
• Participation in another study or use of experimental treatments recently.
• Serious heart conditions or history of heart failure.
• Certain heart rhythm issues.
• Fluid buildup in the chest or abdomen needing immediate treatment.
• Brain metastases.
• Autoimmune diseases or uncontrolled diabetes.
• History of bone marrow or stem cell transplant.
• HIV or AIDS.
• Active COVID-19 infection.
• Active hepatitis infection.
• Liver complications or large tumors near vital structures.
• BRCA mutation testing required if not previously treated with a specific inhibitor.
• Any condition that increases risk or affects study participation.
• Known substance abuse or conditions affecting participation.