NCT06128525

Prostate Resection After Microwave Ablation (PRAMA)

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
DEVICE	Microwave Ablation	Undergo transperineal MRI/US fusion guided transperineal targeted microwave ablation
DEVICE	Multiparametric Magnetic Resonance Imaging	Undergo planning mpMRI of prostate
OTHER	Questionnaire Administration	Ancillary studies
PROCEDURE	Radical Prostatectomy	Undergo RP

Timeline

• Start date: 2023-11-10
• Primary completion: 2025-08-26
• Completion: 2025-08-27
• First posted: 2023-11-13
• Last updated: 2025-11-28
• Results posted: 2025-11-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study