MedTrace Logo

Prostate Resection After Microwave Ablation (PRAMA)

NCT06128525 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2025-11-28

Study results available
· View outcomes & findings →

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.

Conditions

  • Prostate Carcinoma

Interventions

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Southern California

    lead OTHER

Principal Investigators

  • Andre Luis Abreu, MD · University of Southern California

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-10
Primary Completion
2025-08-26
Completion
2025-08-27
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06128525 on ClinicalTrials.gov