RECRUITING

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

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Conditions

Prostate CancerIntraoperativeDose escalationOpen-labelSTM-416ResiquimodToll-like receptor 7/8Radical prostatectomyRobotic prostatectomyImmunotherapySTM-416pPSAR848Hydrogel

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-05-08
Study Completion:2026-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06450106

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Males aged 18 years or older at time of informed consent.
  2. 2. Have a histologically confirmed diagnosis of prostate cancer, and are scheduled to undergo radical prostatectomy within 28 days of screening.
  3. 3. Grade Group 2-5.
  4. 4. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2 at Screening.
  5. 5. Have adequate organ and bone marrow function at screening.
  6. 6. Able to understand and be willing to sign an Institutional Review Board/Ethics Committee-approved written informed consent document
  1. 1. Have an invasive malignancy, other than the disease under study.
  2. 2. Anticipated to require the use of a drain after radical prostatectomy.
  3. 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. 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. 5. History of allogeneic organ transplant.
  6. 6. History of primary immunodeficiency.
  7. 7. QTc interval \>470 msec at Screening.

Contacts and Locations

Study Contact

Kayti Aviano
CONTACT
781-605-8632
kayti@surgetx.com

Study Locations (Sites)

Arizona Urology Specialists
Tucson, Arizona, 85715
United States
University of Florida
Gainesville, Florida, 32608
United States

Collaborators and Investigators

Sponsor: SURGE Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-08
Study Completion Date2026-03

Study Record Updates

Study Start Date2025-05-08
Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

  • Intraoperative
  • Dose escalation
  • Open-label
  • STM-416
  • Resiquimod
  • Toll-like receptor 7/8
  • Radical prostatectomy
  • Robotic prostatectomy
  • Immunotherapy
  • STM-416p
  • PSA
  • R848
  • Hydrogel

Additional Relevant MeSH Terms

  • Prostate Cancer