Clinical trial NCT06128525: Prostate Resection After Microwave Ablation (PRAMA)
Official title: PRAMA (Prostate Resection After Microwave Ablation) MRI/Ultrasound Fusion Guided Transperineal Targeted Microwave Ablation for Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Carcinoma
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-11-13
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: The area of the transperineal targeted microwave ablation (TMA) induced tissue death assessed by Triphenyltetrazolium chloride (TTC) staining
timeFrame: At time of radical prostatectomy (RP) immediately after TMA
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: Up to 30 days after RP
measure: Duration of TMA procedure
timeFrame: At completion of TMA
measure: Number of microwave ablations needed to ablate one multiparametric magnetic resonance imaging (mpMRI)-visible lesion
timeFrame: At time of TMA
measure: The area of the transperineal targeted microwave ablation (TMA) induced tissue death assessed by hematoxylin and eosin (H&E) staining.
timeFrame: At time of RP, 30 days after TMA
measure: Difference between the ablation location in the prostate as seen in the KOELIS 3-dimensional map and the ablation location observed histologically on the prostatectomy specimen
timeFrame: Up to 1 month
measure: Change in urinary functions assessed by International Prostate Symptoms Score and uroflowmetry
timeFrame: At baseline and each follow up visit, up to 30 days after RP
measure: Change in erectile functions assessed by International Index of Erectile Function-5 score
timeFrame: At baseline and each follow up visit, up to 30 days after RP
measure: Change in quality of life assessed by Expanded Prostate Cancer Index Composite-26 Short Form
timeFrame: At baseline and each follow up visit, up to 30 days after RP
measure: Difference between the treatment effect dimensions measured histologically on the prostatectomy specimen resected after TMA, compared to the predictive ablation charts provided by the manufacturer
timeFrame: Day after the TMA procedure
measure: Difference between the treatment effect dimensions measured histologically on the prostatectomy specimen resected one month after TMA, compared to post TMA dimensions measured on the pre-RP mpMRI
timeFrame: At time of RP, 30 days after TMA
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Andre Luis Abreu, MD
role: PRINCIPAL_INVESTIGATOR
References: