Prostate Resection After Microwave Ablation (PRAMA)

Description

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

Study Overview

Study Details

Study overview

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.

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

Prostate Resection After Microwave Ablation (PRAMA)

Condition
Prostate Carcinoma
Intervention / Treatment

-

Contacts and Locations

Los Angeles

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Southern California,

Andre Luis Abreu, MD, PRINCIPAL_INVESTIGATOR, University of Southern California

Study Record Dates

2025-11-10