CompletedNot Applicable

Prostate Resection After Microwave Ablation (PRAMA)

United States1 participantsStarted 2023-11-10

Plain-language 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.

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion 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 Exclusion Criteria: * 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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The Area of the Transperineal Targeted Microwave Ablation (TMA) Induced Tissue Death Assessed by Triphenyltetrazolium Chloride (TTC) Staining

Timeframe: At time of radical prostatectomy (RP) immediately after TMA

Trial details

NCT IDNCT06128525

SponsorUniversity of Southern California

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-26

Results submitted2025-11-18

View on ClinicalTrials.gov More Prostate Carcinoma trials