Study of STM-416p Administered to Patients Undergoing Radical Prostatectomy

Launched by SURGE THERAPEUTICS · Jun 6, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called STM-416p, which will be given to men undergoing surgery for prostate cancer, specifically a procedure known as radical prostatectomy. The goal is to see how well STM-416p works when administered during the surgery. The trial is not yet recruiting participants, but it is looking for men aged 18 and older who have been diagnosed with prostate cancer and are scheduled for surgery within the next 28 days. To be eligible, participants should have a certain level of cancer severity and good overall health, meaning their organs and bone marrow are functioning well.

If you join the trial, you’ll receive STM-416p during your surgery, and the researchers will monitor your health and the effects of the treatment. It’s important to note that there are certain criteria that could exclude you from participating, such as having other types of cancer, needing a drain after surgery, or having received other cancer treatments shortly before the trial. Overall, this study aims to explore a potential new approach to improve outcomes for men with prostate cancer undergoing surgery.

Gender

MALE

Eligibility criteria

• Inclusion 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
• Exclusion Criteria:
• • 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.