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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

Study 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.Check my eligibility

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.See study design

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 below

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The area of the transperineal targeted microwave ablation (TMA) induced tissue death assessed by Triphenyltetrazolium chloride (TTC) staining

Secondary outcome measures

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 more

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

Radical Prostatectomy

2005

Completed Phase 2

~4550

Biospecimen Collection

2004

Completed Phase 2

~1700

Microwave Ablation

2021

Completed Phase 2

~1650

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,671 Previous Clinical Trials

40,926,754 Total Patients Enrolled

560 Trials studying Prostate Cancer

507,080 Patients Enrolled for Prostate Cancer

University of Southern CaliforniaLead Sponsor

906 Previous Clinical Trials

1,596,273 Total Patients Enrolled

17 Trials studying Prostate Cancer

9,407 Patients Enrolled for Prostate Cancer

Andre Luis Abreu, MDPrincipal InvestigatorUniversity of Southern California

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research project actively seeking participants at the moment?

"Unfortunately, this clinical trial is no longer recruiting participants. It was initially posted on November 13th 2023 and last updated on November 6th 2023. Thankfully, there are numerous other medical studies that require enrolment available at the moment with a total of 1,369 trials in need of research subjects."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Prostate Resection After Microwave Ablation (PRAMA)

2023. "Prostate Resection After Microwave Ablation (PRAMA)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06128525.