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

Recruiting now · Phase 1

Conditions studied: Prostate Cancer

In brief

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

Key facts

Study ID

NCT06450106

Run by

SURGE Therapeutics

People needed

18

Starts

2025-05-08

Expected to finish

2026-12-01

Last updated by the study team

2026-02-19

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Arizona Urology Specialists — Tucson, Arizona, United States (enrolling)
• University of Florida — Gainesville, Florida, United States (enrolling)
• Australian Prostate Center — Melbourne N., Victoria, Australia (enrolling)
• Epworth HealthCare — Melbourne N., Victoria, Australia (enrolling)

Full record on ClinicalTrials.gov

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