Testing STM-416p During Surgery to Remove the Prostate
Tests a new drug, STM-416p, given during surgery in adults with prostate cancer.
Plain-language title generated from the registry record
Registry title: Study of STM-416p Administered to Patients Undergoing Radical Prostatectomy
Key facts
- Where
- Melbourne N., AustraliaSee the 2 sites
- Phase
- Phase 1
Where in Australia
- Australian Prostate CenterMelbourne N., AustraliaTaking people
- Epworth HealthCareMelbourne N., AustraliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- SURGE Therapeutics
- Trial code
- NCT06450106
- Record updated
- 19 February 2026
- Original description
A Study of STM-416p Administered Intraoperatively to Patients Undergoing Radical ProstatectomyRead full original descriptionShow less
A Phase 1 Dose Escalation Study of STM-416p Administered Intraoperatively to Patients Undergoing Radical Prostatectomy
A Study of STM-416p Administered Intraoperatively to Patients Undergoing Radical Prostatectomy
Inclusion: 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: 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; Have an invasive malignancy, other than the disease under study; History of allogeneic organ transplant; History of primary immunodeficiency; 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; QTc interval >470 msec at Screening; Anticipated to require the use of a drain after radical prostatectomy.