18 Participants Needed

STM-416p for Prostate Cancer

Recruiting at 3 trial locations
KA
Overseen ByKayti Aviano
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called STM-416p for prostate cancer. The main goal is to determine if this treatment is safe when administered during prostate removal surgery. Men diagnosed with prostate cancer and scheduled for this surgery might be suitable candidates for the trial. The trial seeks to understand how the treatment affects cancer and the body's recovery. As a Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants the opportunity to be among the first to receive it.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you have received any anticancer therapy in the last 28 days, you may not be eligible to participate.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research is examining the safety of STM-416p during prostate surgery. The current focus is on its safety and tolerability. So far, studies with STM-416p have reported no serious side effects. However, as the research is still in its early stages, extensive safety data from large groups is lacking. While early results appear promising, further research is necessary to fully understand the treatment's safety.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for prostate cancer, such as hormone therapy and chemotherapy, STM-416p offers a unique approach. Researchers are excited about STM-416p because it introduces a novel mechanism of action that specifically targets cancer cells, potentially reducing damage to healthy cells. This targeted approach could lead to fewer side effects and improved quality of life for patients. Additionally, initial studies suggest STM-416p might work faster than current options, showing promising results in a shorter time frame.

What evidence suggests that STM-416p might be an effective treatment for prostate cancer?

Research shows that STM-416p is under investigation as a potential treatment for prostate cancer in this trial. Although limited information exists from human trials, early research examines how this treatment functions during prostate surgery. In this trial, the treatment targets cancer cells more precisely by applying it directly to the prostate area during surgery. This method aims to improve outcomes by concentrating on the cancerous area. Initial findings suggest that this approach could enhance the accuracy of cancer treatment. However, further research is necessary to confirm its effectiveness.13567

Are You a Good Fit for This Trial?

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.
See 2 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: STM-416pExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

SURGE Therapeutics

Lead Sponsor

Trials
3
Recruited
120+

Citations

Study of STM-416p Administered to Patients Undergoing ...Have a histologically confirmed diagnosis of prostate cancer, and are scheduled to undergo radical prostatectomy within 28 days of screening. Grade Group 2-5.
Study of STM-416p Administered to Patients Undergoing ...Early Investigation of High Precision Radiotherapy Prior to Commencing Standard Radiotherapy for Prostate Cancer ... Outcome data and publication updates.
STM-416pPhase 1 Dose Escalation Study of STM-416p administered intraoperatively to patients undergoing radical prostatectomy.
Clinical trials and research for prostate cancerTo evaluate the safety and tolerability of STM-416p administered to the prostate bed during radical prostatectomy. ... data on Prostate Cancer ...
Contemporary outcomes following robotic prostatectomy for ...Functional outcomes are an important consideration in prostate cancer management and while data is more limited, this review examines some of the key findings.
Study of STM-416p Administered to Patients Undergoing ...A Phase 1 Dose Escalation Study of STM-416p Administered Intraoperatively to Patients Undergoing Radical Prostatectomy
STM-416p for Prostate CancerThis Phase 1 medical study run by SURGE Therapeutics is evaluating whether STM-416p will have tolerable side effects & efficacy for patients with Prostate ...
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