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New treatment option for Prostate Cancer
Official title Study of STM-416p Administered to Patients Undergoing Radical Prostatectomy
ClinicalTrials.gov ID: NCT06450106
What this study is testing
What is STM-416p?
STM-416p is an investigational medicine, being studied as a potential treatment for prostate cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A Study of STM-416p Administered Intraoperatively to Patients Undergoing Radical Prostatectomy
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Males aged 18 years or older at time of informed consent.
- Have a histologically confirmed diagnosis of prostate cancer, and are scheduled to undergo radical prostatectomy within 28 days of screening.
- Grade Group 2-5.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2 at Screening.
- Have adequate organ and bone marrow function at screening.
You likely can't join if
- Have an invasive malignancy, other than the disease under study.
- Anticipated to require the use of a drain after radical prostatectomy.
- Received any other anticancer therapy (e.g., including but not limited to chemotherapy, biologic therapy, immunotherapy, targeted therapy, endocrine...
- History of allergic reactions attributed to compounds of similar chemical or biologic composition as those used in the STM-416p formulation including...
- History of allogeneic organ transplant.
- History of primary immunodeficiency.
See the full eligibility criteria
- Males aged 18 years or older at time of informed consent.
- Have a histologically confirmed diagnosis of prostate cancer, and are scheduled to undergo radical prostatectomy within 28 days of screening.
- Grade Group 2-5.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2 at Screening.
- Have adequate organ and bone marrow function at screening.
- Able to understand and be willing to sign an Institutional Review Board/Ethics Committee-approved written informed consent document
- Have an invasive malignancy, other than the disease under study.
- Anticipated to require the use of a drain after radical prostatectomy.
- 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.
- 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.
- History of allogeneic organ transplant.
- History of primary immunodeficiency.
- QTc interval \>470 msec at Screening.
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- Gainesville, Florida, United States
- Melbourne N., Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States; Gainesville, Florida, United States; Melbourne N., Victoria, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.