Prostate Resection After Microwave Ablation (PRAMA)

Study Overview
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Brief Summary
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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
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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.

Official Title
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PRAMA (Prostate Resection After Microwave Ablation) MRI/Ultrasound Fusion Guided Transperineal Targeted Microwave Ablation for Prostate Cancer

Conditions
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Prostate Carcinoma

Intervention / Treatment
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* Procedure: Biospecimen Collection
* Device: Microwave Ablation
* Device: Multiparametric Magnetic Resonance Imaging
* Other: Questionnaire Administration
* Procedure: Radical Prostatectomy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (TMA, radical prostatectomy)<br>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 may undergo planning mpMRI of prostate prior to TMA. Patients also undergo blood sample collection at screening and post RP. | Procedure: Biospecimen Collection<br>* Undergo blood sample collection<br>* Other names: Specimen Collection;Device: Microwave Ablation<br>* Undergo transperineal MRI/US fusion guided transperineal targeted microwave ablation<br>* Other names: Ablation, Microwave;Device: Multiparametric Magnetic Resonance Imaging<br>* Undergo planning mpMRI of prostate<br>* Other names: Multiparametric MRI;Other: Questionnaire Administration<br>* Ancillary studies<br>Procedure: Radical Prostatectomy<br>* Undergo RP<br>* Other names: Prostatovesiculectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The area of the transperineal targeted microwave ablation (TMA) induced tissue death assessed by Triphenyltetrazolium chloride (TTC) staining | The excised prostate will be sliced at 4 mm intervals. Each slice will be embedded, and a pathologist will examine the slides corresponding to each slice. The pathologist will be blinded to MR and ultrasound imaging results. TTC staining is performed to determine the dead tissue induced by the TMA. | At time of radical prostatectomy (RP) immediately after TMA | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events | All adverse events graded according to the Clavien Dindo Classification | Up to 30 days after RP | 
| Duration of TMA procedure | Measured by the probe-in/probe-out time and the ablation time. | At completion of TMA | 
| Number of microwave ablations needed to ablate one multiparametric magnetic resonance imaging (mpMRI)-visible lesion | Count of microwave ablations needed to ablate one mpMRI-visible lesion will be reported | At time of TMA | 
| The area of the transperineal targeted microwave ablation (TMA) induced tissue death assessed by hematoxylin and eosin (H&E) staining. | The excised prostate will be sliced at 4 mm intervals. Each slice will be embedded, and a pathologist will examine the slides corresponding to each slice. The pathologist will be blinded to MR and ultrasound imaging results. H&E staining is performed to determine the dead tissue induced by the TMA. | At time of RP, 30 days after TMA | 
| 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 | The difference between the ablation location as seen in the KOELIS 3D reconstruction of the prostate (3D Map) will be compared to the ablation location observed histologically on the prostatectomy specimen. | Up to 1 month | 
| Change in urinary functions assessed by International Prostate Symptoms Score and uroflowmetry | Urinary functions will be measured using International Prostate Symptoms Score (IPSS) and uroflowmetry. The IPSS can be 0-35 (higher score means worse urinary function). Uroflowmetry evaluates the maximum flow rate, average flow rate, flow time, voided volume, and the waveform of the flow rate. | At baseline and each follow up visit, up to 30 days after RP | 
| Change in erectile functions assessed by International Index of Erectile Function-5 score | Erectile functions will be measured using International Index of Erectile Function (IIEF)-5 score. IIEF-5 score can be 5-25 (higher score means better erectile function). | At baseline and each follow up visit, up to 30 days after RP | 
| Change in quality of life assessed by Expanded Prostate Cancer Index Composite-26 Short Form | Quality of life (QOL) will be measured using Expanded Prostate Cancer Index Composite (EPIC)-26 Short Form score. EPIC-26 includes 13 questionnaires assessing several aspects of QOL. The interpretation of whether a higher numerical value in response to a questionnaire indicates a favorable outcome. | At baseline and each follow up visit, up to 30 days after RP | 
| 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 | The comparison of the difference between the treatment effect dimensions measured histologically on the prostatectomy specimen resected after TMA and the predictive ablation charts provided by the manufacturer will be performed. | Day after the TMA procedure | 
| 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 | The comparison 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 will be performed. | At time of RP, 30 days after TMA |