Prostate Resection After Microwave Ablation (PRAMA)

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Southern California
Study ID
NCT06128525
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 10, 2023
Status verified
Nov 2025
Primary completion
Aug 26, 2025
Completion
Aug 27, 2025

Study Design

Enrollment
1 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

The Area of the Transperineal Targeted Microwave Ablation (TMA) Induced Tissue Death Assessed by Triphenyltetrazolium Chloride (TTC) Staining [ Time Frame: At time of radical prostatectomy (RP) immediately after TMA ]

Locations (1)

FacilityCityStateZIPSite coordinators
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-

Find similar trials in Los Angeles, CA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
USC / Norris Comprehensive Cancer Center· Los Angeles, CA

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