Prostate Resection After Microwave Ablation (PRAMA)

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

PRIMARY OBJECTIVE: I. To determine the feasibility of transperineal targeted microwave ablation of an MRI-identified index prostate cancer in patients undergoing radical prostatectomy. SECONDARY OBJECTIVES: I. KOELIS Trinity ability to plan and guide treatment needles and ablations in the prostate index lesion. II. Impact of treatments on functional outcomes and quality of life. III. Predictability of Medwaves Avecure microwave ablation charts. IV. Predictability of post microwave ablation mpMRI. OUTLINE: 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 undergo planning mpMRI of prostate prior to TMA. Patients also undergo blood sample collection at screening and post RP. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06128525
Study type	Interventional
Source	University of Southern California
Contact	Ileana Aldana
Phone	323-865-0702
Email	Ileana.aldana@med.usc.edu
Status	Recruiting
Phase	N/A
Start date	November 10, 2023
Completion date	November 10, 2025

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04457232` - Prospective Exploratory Study of FAPi PET/CT in Prostate Cancer With Histopathology Validation	Phase 1
Active, not recruiting	`NCT03661437` - Systemic Light Exposure in Preventing Frailty in Older Patients With Prostate Cancer on Hormonal Therapy	Early Phase 1
Completed	`NCT02337465` - KV-CBCT and Ultrasound Imaging in Guiding Radiation Therapy in Patients With Prostate, Liver, or Pancreatic Cancer	N/A
Completed	`NCT03013413` - Ultrasound-Based Imaging Using the Aixplorer System in Diagnosing Prostate Cancer in Patients Undergoing Biopsy	N/A
Recruiting	`NCT06037863` - Evaluation of the Impact of Empty Versus Full Bladder in Patients With Prostate Cancer, RELIEF Trial	N/A
Active, not recruiting	`NCT03580499` - Vitamin B6 in Reducing Hot Flashes in Participants With Prostate Cancer Undergoing Antiandrogen Therapy	N/A
Completed	`NCT03326440` - Virtual Environment Radiotherapy to Improve Patients' Compliance to Radiotherapy (RT) in Prostate Cancer	N/A
Recruiting	`NCT04597359` - To Evaluate if Green Tea Can be Effective in Reducing the Progression of Prostate Cancer in Men on Close Monitoring	Phase 2
Active, not recruiting	`NCT03263650` - Study of Olaparib Maintenance Following Cabazitaxel-Carbo in Men With AVPC	Phase 2
Active, not recruiting	`NCT04600336` - Testing the Effects of Oxybutynin for the Treatment of Hot Flashes in Men Receiving Hormone Therapy for Prostate Cancer	Phase 2
Active, not recruiting	`NCT04299620` - Micro-Ultrasound for the Detection and Localization of Prostate Cancer Tumors in Patients Undergoing Radical Prostatectomy	N/A
Completed	`NCT04976257` - Pharmacokinetics of IA and IV Ga68-PSMA-11 Infusion	Early Phase 1
Completed	`NCT02957981` - The Genetic Education for Men Trial: Web-Based Education vs. Standard Care	N/A
Withdrawn	`NCT03408561` - Social Media Listening in Improving Clinical Trial Recruitment in Patients With Cancer	N/A
Enrolling by invitation	`NCT06347809` - DNA Methylation in Adenocarcinoma of the Prostate: Analysis of Validated Biomarkers in Urine
Enrolling by invitation	`NCT04254133` - Genetic Information to Inform Treatment and Screening for Prostate Cancer, GIFTS Study
Recruiting	`NCT05519878` - Light Therapy and Occupational Therapy Fatigue Management-Based Intervention for Patients With Genitourinary Cancers	N/A
Recruiting	`NCT02994758` - Development of Diagnostics and Treatment of Urological Cancers	N/A
Completed	`NCT01497431` - Se-Methyl-Seleno-L-Cysteine or Selenomethionine in Preventing Prostate Cancer in Healthy Participants	Phase 1
Active, not recruiting	`NCT00002540` - Screening for Prostate Cancer in Older Patients (PLCO Screening Trial)	N/A