Clinical Trials

Inclusion Criteria -
Patients with Untreated High Risk Prostate Cancer:

Patients with prostate cancer, who have not received anticancer therapy and who meet at least one of the following criteria for high-risk prostate cancer are eligible for inclusion in this expanded access IND study:

• Serum prostate-specific antigen (PSA) concentration of 20 ng/mL or more.
• Pathologic criteria of International Society of Uropathology (ISUP) grade group 3–5: ISUP grades 3-5 are equivalent to pathologic Gleason scores of 4+3, 8, 9 or 10.
• Local staging of T3 or worse, indicating that cancer has invaded into tissues outside of the prostate gland, as seen at either CT or MRI.

Inclusion Criteria - 
Patients with Biochemically Recurrent Prostate Cancer:

Patients with prostate cancer, who have undergone initial anticancer therapy in the form of surgery or radiation and who meet at least one of the following criteria are eligible for inclusion in this expanded access IND study:

• In patients who are post prostatectomy, a PSA > 0.2ng/mL on 2 consecutive tests;
• In patients who have undergone definitive prostate radiation, a PSA rise ≥ 2.0 ng/mL above nadir PSA.

Exclusion Criteria:

• Patients unable to provide informed consent.
• Patients with a life expectancy less than 6 months.
• Additional exclusion criteria may be added based on demand.