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Procedure

MR-Guided Focal Therapy for Prostate Cancer

N/A
Recruiting
Led By Peter A Pinto, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
<= 4 cores positive in a standard 12 core biopsy and <= 4 cores positive on MRI target lesions biopsy where 2 cores are taken from each of the one or two MRI target lesions
Gleason Score <= 7
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, 12, 18, 24, and 36 months
Awards & highlights

Study Summary

This trial is testing a new way to treat localized prostate cancer using Transurethral UltraSound Ablation (TULSA) in combination with MRI guidance.

Who is the study for?
This trial is for English-speaking adults aged 18+ with localized prostate cancer visible on MRI and treatable by thermal ablation. They must have a Gleason Score <= 7, PSA < 20 ng/ml, adequate organ function, and be able to consent. Exclusions include inability to undergo MRI, severe urinary symptoms (IPSS > 20), multiple cancer lesions on MRI, or serious illnesses that could affect study participation.Check my eligibility
What is being tested?
The study tests Transurethral UltraSound Ablation (TULSA) guided by MRI for treating localized prostate cancer. Participants will undergo TULSA where heat destroys targeted cancer areas in the prostate using an ultrasound applicator controlled by a robotic arm while being monitored via MRI.See study design
What are the potential side effects?
Potential side effects of TULSA may include discomfort from the procedure itself, possible damage to surrounding tissues due to heat application, urinary issues related to catheter use post-procedure (1-7 days), and general risks associated with sedation or anesthesia used during treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My biopsy showed 4 or fewer positive cores out of 12, and the same for MRI-targeted lesions.
Select...
My prostate cancer has a Gleason score of 7 or less.
Select...
My kidney function, measured by creatinine clearance, is adequate.
Select...
My prostate cancer has a Gleason score of 7 or less.
Select...
I have prostate cancer that can be treated with ultrasound.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6, 12, 18, 24, and 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, 12, 18, 24, and 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
feasibility and tolerability
Secondary outcome measures
changes in imaging and biopsy characteristics
effect of thermal ablation on short- and long-term complication rates
outcome of TULSA ablation
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: 1/Arm 1Experimental Treatment1 Intervention
Ultrasound ablation of focal prostate cancer

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,665 Previous Clinical Trials
40,925,839 Total Patients Enrolled
560 Trials studying Prostate Cancer
507,080 Patients Enrolled for Prostate Cancer
Peter A Pinto, M.D.Principal InvestigatorNational Cancer Institute (NCI)
5 Previous Clinical Trials
3,791 Total Patients Enrolled
5 Trials studying Prostate Cancer
3,791 Patients Enrolled for Prostate Cancer

Media Library

TULSA-PRO (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04808427 — N/A
Prostate Cancer Research Study Groups: 1/Arm 1
Prostate Cancer Clinical Trial 2023: TULSA-PRO Highlights & Side Effects. Trial Name: NCT04808427 — N/A
TULSA-PRO (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04808427 — N/A

Frequently Asked Questions

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

Are there still available slots for participants in this research endeavor?

"Information provided on clinicaltrials.gov reveals that this medical project is not presently accepting participants. This trial, which was first advertised on December 4th 2022 and most recently updated November 28th 2022, is currently paused but there are 1,322 other studies seeking volunteers now."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
Florida
Arizona
How old are they?
65+
What site did they apply to?
National Institutes of Health Clinical Center
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
Pilot Study to Investigate Magnetic Resonance (MR) Image Guided Focal Therapy in Prostate Cancer
2023. "Pilot Study to Investigate Magnetic Resonance (MR) Image Guided Focal Therapy in Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04808427.
~10 spots leftby May 2027
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