STM-416p for Prostate Cancer
Recruiting at 1 trial location
KA
Overseen ByKayti Aviano
Age: 18+
Sex: Male
Trial Phase: Phase 1
Sponsor: SURGE Therapeutics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Trial Summary
What is the purpose of this trial?
A Study of STM-416p Administered Intraoperatively to Patients Undergoing Radical Prostatectomy
Eligibility Criteria
This trial is for individuals with confirmed prostate cancer, scheduled for radical prostatectomy within 28 days of screening. Participants must have adequate organ and bone marrow function, understand the consent form, and have a performance status indicating they are still up and about more than half of the day.Inclusion Criteria
I can understand and am willing to sign a consent form.
I can take care of myself but might not be able to do heavy physical work.
I have prostate cancer and will have surgery to remove my prostate within 28 days.
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Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
STM-416p is administered intraoperatively during radical prostatectomy
Day 0
1 visit (in-person, intraoperative)
Initial Follow-up
Participants are monitored for dose-limiting toxicities and adverse events
21 days
Multiple assessments (in-person and virtual)
Extended Follow-up
Participants are monitored for treatment-emergent adverse events and surgical wound healing
Up to 90 days
Treatment Details
Interventions
- STM-416p
Trial Overview The study tests STM-416p administered during surgery to patients having their prostates removed due to cancer. It aims to evaluate the safety and effects of this treatment in a surgical setting.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: STM-416pExperimental Treatment1 Intervention
STM-416p
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Who Is Running the Clinical Trial?
SURGE Therapeutics
Lead Sponsor
Trials
3
Recruited
120+
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