RightFit
RecruitingPhase 1

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests STM-416p given during surgery to remove the whole prostate. It is for men age 18 or older with prostate cancer who are scheduled for this surgery.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are a man age 18 or older when you agree to join.
  • A tissue test confirmed prostate cancer, and surgery to remove your whole prostate is planned within 28 days of screening.
  • Your cancer is Grade Group 2–5, a rating of how abnormal the cancer cells look.
  • You can care for yourself and are out of bed or a chair for at least half of your waking hours.
  • Tests show that your organs and bone marrow, which makes blood cells, work well enough.
  • You can understand and are willing to sign the approved study consent form.

Who can't join

  • You have another cancer that grows into nearby tissue.
  • You are expected to need a tube to drain fluid after prostate surgery.
  • You received any other cancer treatment within the past 28 days.
  • You have had an allergic reaction to substances like those in STM-416p, including poloxamer 407 and sodium hyaluronate.
  • You have had an organ transplant from another person.
  • You have a history of primary immune deficiency, a condition in which the body's defenses do not work properly.
  • Your screening heart test shows a QTc interval over 470 milliseconds, meaning the heart takes too long to reset between beats.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (2)

AZ

FL