NCT06450106 · SURGE Therapeutics
Study of STM-416p Administered to Patients Undergoing Radical Prostatectomy
What this study is about
A Study of STM-416p Administered Intraoperatively to Patients Undergoing Radical Prostatectomy
View original scientific description
A Study of STM-416p Administered Intraoperatively to Patients Undergoing Radical Prostatectomy
Interventions
DRUG
STM-416p
STM-416p monotherapy
Primary outcome measures
Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability]
Time frame: 21 Days
Incidence of dose-limiting toxicities (DLTs) over the first 21-days of study treatment
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Time on trial up to 90 days
Incidence of serious adverse events (SAEs), and adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Males aged 18 years or older at time of informed consent.
- Have a histologically confirmed diagnosis of prostate cancer, and are scheduled to undergo radical prostatectomy within 28 days of screening.
- Grade Group 2-5.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2 at Screening.
- Have adequate organ and bone marrow function at screening.
- Able to understand and be willing to sign an Institutional Review Board/Ethics Committee-approved written informed consent document
Exclusion criteria
- Have an invasive malignancy, other than the disease under study.
- Anticipated to require the use of a drain after radical prostatectomy.
- 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.
- 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.
- History of allogeneic organ transplant.
- History of primary immunodeficiency.
- QTc interval \>470 msec at Screening.
Where
- Tucson, Arizona
- Gainesville, Florida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 19, 2026 · Source of record for eligibility and locations