Administering STM-416p during prostate cancer surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 interventional study evaluates the safety and dosage of STM-416p when administered intraoperatively to patients undergoing radical prostatectomy for prostate cancer. The study aims to determine the appropriate dose escalation of STM-416p in a controlled setting. Participants will be closely monitored for any adverse effects and the efficacy of the treatment in conjunction with the surgical procedure. The study focuses on males with confirmed prostate cancer scheduled for surgery within a specific timeframe.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: Kayti Aviano
• Email: kayti@surgetx.com
• Phone: 781-605-8632

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.