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Procedure
Microwave Ablation + Prostate Resection for Prostate Cancer
N/A
Recruiting
Led By Andre Luis Abreu, MD
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult men diagnosed with prostate cancer and undergoing prostatectomy as treatment of choice
Patient suitable for intravenous (IV) sedation or general anesthesia and TMA
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 month
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a less invasive treatment for prostate cancer that may help improve quality of life.
Who is the study for?
Men with prostate cancer who have chosen surgery as their treatment and whose tumors can be seen on an MRI. They must be able to undergo sedation or anesthesia for the procedure, and agree to participate by signing a consent form.
What is being tested?
The trial is testing if using targeted microwave ablation (TMA) before removing the prostate gland helps treat prostate cancer better. TMA is less invasive, uses heat to kill tumor cells, and aims to preserve healthy tissue with the help of advanced imaging techniques.
What are the potential side effects?
Potential side effects may include discomfort at the ablation site, risks associated with sedation or general anesthesia, possible damage to surrounding tissues despite image guidance, and typical surgical risks from radical prostatectomy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a man with prostate cancer and will have surgery to remove my prostate.
Select...
I can safely undergo procedures with IV sedation or general anesthesia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 month
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The area of the transperineal targeted microwave ablation (TMA) induced tissue death assessed by Triphenyltetrazolium chloride (TTC) staining
Secondary study objectives
Change in erectile functions assessed by International Index of Erectile Function-5 score
Change in quality of life assessed by Expanded Prostate Cancer Index Composite-26 Short Form
Change in urinary functions assessed by International Prostate Symptoms Score and uroflowmetry
+7 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (TMA, radical prostatectomy)Experimental Treatment5 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Multiparametric Magnetic Resonance Imaging
2021
Completed Early Phase 1
~10
Biospecimen Collection
2004
Completed Phase 3
~2030
Radical Prostatectomy
2005
Completed Phase 2
~4550
Microwave Ablation
2021
Completed Phase 2
~1650
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,956 Previous Clinical Trials
41,112,078 Total Patients Enrolled
516 Trials studying Prostate Cancer
332,960 Patients Enrolled for Prostate Cancer
University of Southern CaliforniaLead Sponsor
946 Previous Clinical Trials
1,604,604 Total Patients Enrolled
12 Trials studying Prostate Cancer
9,224 Patients Enrolled for Prostate Cancer
Andre Luis Abreu, MDPrincipal InvestigatorUniversity of Southern California