BridgeMD
New treatment option for Prostate Cancer
Official title Prostate Cancer Treatment Using Androgen Deprivation Therapy and Focal Prostate Ablation
ClinicalTrials.gov ID: NCT05790213
What this study is testing
What is Androgen Deprivation Therapy (ADT)?
Androgen Deprivation Therapy (ADT) 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
- The purpose of this research is to gather information on the safety and effectiveness of combining focal prostate ablation therapy ((aka Focal Therapy, a surgical procedure) and androgen deprivation therapy (hormone therapy).
- Phase 2: a mid-size study of how well it works
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
- people must have intermediate-risk PCa as defined by the below criteria: a. Favorable intermediate-risk PCa: i. ≤ clinical stage T2c, GG2, and PSA ≤...
- No mpMRI evidence of extra-prostatic extension (EPE) or seminal vesicle invasion, and if seminal vesical invasion is suspected, it must be excluded...
- people must have chosen to get Focal Therapy for the treatment of prostate cancer.
- people must have confirmed non-metastatic PCa following SOC screening for patients with unfavorable intermediate-risk PCa, a combination of computed...
- Subject must be male ≥ 18 years-old.
You likely can't join if
- Subject has had prior or current PCa therapies, such as biologic, chemotherapy, hormone therapy, radiotherapy or surgery for PCa. people may not have...
- people with locally advanced, nodal or metastatic prostate cancer.
- people who are unfit for pelvic mpMRI scanning (e.g., severe claustrophobia, permanent cardiac pacemaker, metallic implants that are likely to...
- History of allergy or intolerance to study drug components.
- History of bilateral orchiectomy.
- If the subject has an uncontrolled or major debilitating inter-current illness.
See the full eligibility criteria
- people must have intermediate-risk PCa as defined by the below criteria: a. Favorable intermediate-risk PCa: i. ≤ clinical stage T2c, GG2, and PSA ≤ 10 ng/mL, and \<50% positive biopsy cores with PCa b. Unfavorable...
- No mpMRI evidence of extra-prostatic extension (EPE) or seminal vesicle invasion, and if seminal vesical invasion is suspected, it must be excluded by prostate biopsy.
- people must have chosen to get Focal Therapy for the treatment of prostate cancer.
- people must have confirmed non-metastatic PCa following SOC screening for patients with unfavorable intermediate-risk PCa, a combination of computed tomography imaging of the abdomen and pelvis (CTAP) and...
- Subject must be male ≥ 18 years-old.
- people must have a life expectancy of at least 10-years per the opinion of the treating investigator.
- people must be designated as Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 or Karnofsky Performance Status Scale Score ≥ 60%, see Appendix A).
- people must be fit to undergo general anesthesia and the FT surgical procedure, which includes adequate visualization of the prostate gland on transrectal ultrasound imaging, access to the urethra, perineum and rectum...
- people must have adequate organ and marrow function as defined below: Hemoglobin ≥ 10 g/dL Leukocytes ≥ 3,000/mcL Absolute neutrophil count ≥ 1,500/mcL Platelets ≥ 100,000/mcL Total bilirubin ≤ 1.5 x institutional upper...
- people with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for...
- people who are sexually active with a woman of childbearing potential must agree to use a condom with spermicidal foam/gel/film/cream/suppository and his partner must also be practicing a highly effective method of...
- Ability to understand and the willingness to sign a written informed consent document.
- Subject has had prior or current PCa therapies, such as biologic, chemotherapy, hormone therapy, radiotherapy or surgery for PCa. people may not have had undergone pelvic radiation, chemotherapy or immunotherapy...
- people with locally advanced, nodal or metastatic prostate cancer.
- people who are unfit for pelvic mpMRI scanning (e.g., severe claustrophobia, permanent cardiac pacemaker, metallic implants that are likely to contribute to significant image artifacts, allergy or contraindication to...
- History of allergy or intolerance to study drug components.
- History of bilateral orchiectomy.
- If the subject has an uncontrolled or major debilitating inter-current illness.
- people who are receiving any other investigational agents, or who have received other investigational agents in the past and who are no longer receiving these investigational agents may be eligible at the discretion of...
- Judgment by the treating investigator or PI that the subject is unsuitable to participate in the study and the subject is unlikely to comply with study procedures, restrictions and requirements.
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
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 Chicago, Illinois, United States. 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.