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RecruitingLast updated: 10 February 2026

SURGE: This study is recruiting people with prostate cancer who are planning to undergo a radical prostatectomy to test the safety and effect of delivering a drug during the surgeryA Phase 1 Dose Escalation Study of STM-416p Administered Intraoperatively to Patients Undergoing Radical Prostatectomy

Trial purpose

Medical clipboardCancer treatment

Tumor type

Urinary System Cancers Genitourinary

Age

People18+

Trial acronym

SURGE

Clinical summary

Summary

All eligible participants in this study will undergo their planned radical prostatectomy procedure. During the prostate removal surgery, the investigational drug STM-416p will be administered directly into the surgical site.

Conditions

This trial is treating people with prostate cancer who are scheduled to undergo radical prostatectomy

Eligibility

Inclusion

  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

  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.

Inclusion

  • You have the type of cancer, symptoms, or health risks that this clinical trial is focused on.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

SURGE Therapeutics

Scientific Title

A Phase 1 Dose Escalation Study of STM-416p Administered Intraoperatively to Patients Undergoing Radical Prostatectomy

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