Prostate Resection After Microwave Ablation (PRAMA)

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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Carcinoma
• Intervention / Treatment: Other: Questionnaire Administration; Procedure: Biospecimen Collection; Device: Microwave Ablation; Device: Multiparametric Magnetic Resonance Imaging; Procedure: Radical Prostatectomy

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • USC / Norris Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment (TMA, radical prostatectomy); 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.

Other: Questionnaire Administration; Ancillary studies; Procedure: Biospecimen Collection; Undergo blood sample collection; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Device: Microwave Ablation; Undergo transperineal MRI/US fusion guided transperineal targeted microwave ablation; Other Names: Ablation, Microwave; Device: Multiparametric Magnetic Resonance Imaging; Undergo planning mpMRI of prostate; Other Names: Multiparametric MRI; MP-MRI; mpMRI; Multi-parametric MRI; Procedure: Radical Prostatectomy; Undergo RP; Other Names: Prostatovesiculectomy

What is the study measuring?

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 Targeted Microwave Ablation (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

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Andre Luis Abreu, MD, University of Southern California

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2023
• Primary Completion (Actual): August 26, 2025
• Study Completion (Actual): August 27, 2025

Study Registration Dates

• First Submitted: September 8, 2023
• First Submitted That Met QC Criteria: November 6, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Actual): November 28, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Diagnostic Imaging; Magnetic Resonance Imaging; Specimen Handling; Multiparametric Magnetic Resonance Imaging
• Other Study ID Numbers: 4P-23-1 (Other Identifier: USC / Norris Comprehensive Cancer Center); P30CA014089 (U.S. NIH Grant/Contract); NCI-2023-02517 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No