Administering STM-416p during prostate cancer surgery
A Phase 1 Dose Escalation Study of STM-416p Administered Intraoperatively to Patients Undergoing Radical Prostatectomy
This study is testing a new treatment called STM-416p during prostate cancer surgery to see if it's safe and what the right dose is for men having a radical prostatectomy.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | SURGE Therapeutics Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 4 sites (Tucson, Arizona and 3 other locations) |
| Trial ID | NCT06450106 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are males aged 18 or older with histologically confirmed prostate cancer scheduled for radical prostatectomy.
Not a fit: Patients with other invasive malignancies or those requiring additional anticancer therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve outcomes for patients undergoing radical prostatectomy by enhancing the effectiveness of the surgery.
How similar studies have performed: While this approach is novel, similar studies exploring intraoperative treatments for cancer have shown promise in enhancing surgical outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Tucson, Arizona and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.