COMPLETED

Prostate Resection After Microwave Ablation (PRAMA)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-11-10
Study Completion:2025-08-27
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06128525

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult men diagnosed with prostate cancer and undergoing prostatectomy as treatment of choice
  2. * Index lesion visible on multiparametric MRI confirmed by targeted biopsies using KOELIS Trinity (registered trademark)
  3. * Patient suitable for intravenous (IV) sedation or general anesthesia and TMA
  4. * Free, informed, and written consent, dated and signed before the enrollment and before any exam required by the trial
  1. * Past medical history of prostate surgery
  2. * Past medical history of radiotherapy or pelvic trauma
  3. * Past treatment for prostate cancer (PCa) (radiation, ablation, androgen deprivation therapy \[ADT\], chemotherapy)

Contacts and Locations

Principal Investigator

Andre Luis Abreu, MD
PRINCIPAL_INVESTIGATOR
University of Southern California

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of Southern California

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-10
Study Completion Date2025-08-27

Study Record Updates

Study Start Date2023-11-10
Study Completion Date2025-08-27

Terms related to this study

Additional Relevant MeSH Terms

  • Prostate Carcinoma