Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
Eligibility Criteria
- 1. Males aged 18 years or older at time of informed consent.
- 2. Have a histologically confirmed diagnosis of prostate cancer, and are scheduled to undergo radical prostatectomy within 28 days of screening.
- 3. Grade Group 2-5.
- 4. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2 at Screening.
- 5. Have adequate organ and bone marrow function at screening.
- 6. Able to understand and be willing to sign an Institutional Review Board/Ethics Committee-approved written informed consent document
- 1. Have an invasive malignancy, other than the disease under study.
- 2. Anticipated to require the use of a drain after radical prostatectomy.
- 3. Received any other anticancer therapy (e.g., including but not limited to chemotherapy, biologic therapy, immunotherapy, targeted therapy, endocrine therapy, radiation therapy, intravesical therapy ) within 28 days.
- 4. History of allergic reactions attributed to compounds of similar chemical or biologic composition as those used in the STM-416p formulation including poloxamer 407 and sodium hyaluronate.
- 5. History of allogeneic organ transplant.
- 6. History of primary immunodeficiency.
- 7. QTc interval \>470 msec at Screening.
Ages Eligible for Study
18 Years to
Sexes Eligible for Study
MALE
Accepts Healthy Volunteers
No