PRAMA (Prostate Resection After Microwave Ablation) MRI/Ultrasound Fusion Guided Transperineal Targeted Microwave Ablation for Prostate Cancer
Description
Brief Summary
This phase I trial tests the safety of magnetic resonance imaging (MRI)/ ultrasound (US)
fusion guided transperineal targeted microwave ablation (TMA) before a radical prostatectomy
(RP) and how well it works in treating patients with prostate cancer. Prostate cancer is the
second most common cancer in men and most will never become aggressive. Despite this, most
men choose to undergo treatment which may include surgery. Removing the prostate gland and
sometimes the lymph nodes (radical prostatectomy) is an invasive treatment for prostate
cancer that can have a significant negative on quality of life. TMA is a less invasive
procedure that uses high temperatures given through the skin between the scrotum and the
rectum (transperineal). Using focused high energy and heating tumor cells to several degrees
above normal body temperature may kill them without affecting the surrounding tissue. Using
multiparametric (mp)MRI/US to create a 3-dimensional picture of the tumor may help in
planning and preventing damage to healthy tissue. Giving MRI/US fusion guided transperineal
TMA prior to radical prostatectomy may kill tumor cells, and may improve the quality of life
in patients with prostate cancer.
Detailed Description
PRIMARY OBJECTIVE:
I. To determine the feasibility of transperineal targeted microwave ablation of an
MRI-identified index prostate cancer in patients undergoing radical prostatectomy.
SECONDARY OBJECTIVES:
I. KOELIS Trinity ability to plan and guide treatment needles and ablations in the prostate
index lesion.
II. Impact of treatments on functional outcomes and quality of life. III. Predictability of
Medwaves Avecure microwave ablation charts. IV. Predictability of post microwave ablation
mpMRI.
OUTLINE:
Patients undergo MRI/US fusion guided transperineal targeted TMA and then undergo standard of
care RP same day or at 30 days post-TMA on study. Patients undergo planning mpMRI of prostate
prior to TMA. Patients also undergo blood sample collection at screening and post RP.
Phase
N/AInclusion and Exclusion Criteria
- Adult men diagnosed with prostate cancer and undergoing prostatectomy as treatment of choice
- Index lesion visible on multiparametric MRI confirmed by targeted biopsies using KOELIS Trinity (registered trademark)
- Patient suitable for intravenous (IV) sedation or general anesthesia and TMA
- Free, informed, and written consent, dated and signed before the enrollment and before any exam required by the trial
- Past medical history of prostate surgery
- Past medical history of radiotherapy or pelvic trauma
- Past treatment for prostate cancer (PCa) (radiation, ablation, androgen deprivation therapy [ADT], chemotherapy)
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
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