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Procedure
Focal Laser Ablation for Prostate Cancer
N/A
Recruiting
Led By David Woodrum, MD, PhD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of prostate adenocarcinoma.
Male, 45 years of age or older.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial is evaluating whether a new prostate cancer treatment is safe and effective.
Who is the study for?
Men over 45 with low to intermediate-risk prostate cancer can join this trial. They should have a PSA level of 20 ng/mL or less, a Gleason score up to 7, and no more than three small cancer spots on their prostate that match MRI scans. Participants need to be able to handle anesthesia and give informed consent.Check my eligibility
What is being tested?
The study is testing the safety and effectiveness of using MRI-guided laser heat (LITT) for treating small areas of cancer in the prostate without affecting the rest of it.See study design
What are the potential side effects?
Possible side effects may include discomfort or pain at the treatment site, swelling, urinary issues like difficulty or increased frequency, and risks associated with anesthesia.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with prostate cancer.
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I am a man aged 45 or older.
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My breast cancer is in an early stage, but larger than 2 cm.
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My prostate cancer has a Gleason score of 7 or is intermediate risk.
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My prostate cancer is found in 3 or fewer spots, matching my MRI results.
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My breast cancer is in an early stage, but it is growing.
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My cancer does not have any tumors larger than 2cm.
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I am a man aged 45 or older.
Select...
My prostate cancer has a Gleason score of 7 or is intermediate risk Gleason 6.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of treatment emergent adverse events
Success rate
Secondary outcome measures
Short- and mid-term ablative success
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single arm studyExperimental Treatment1 Intervention
MR guided focal laser ablation of prostate cancer using the Visualase Thermal Therapy System.
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,191 Previous Clinical Trials
3,758,475 Total Patients Enrolled
32 Trials studying Prostate Cancer
8,078 Patients Enrolled for Prostate Cancer
David Woodrum, MD, PhDPrincipal InvestigatorMayo Clinic
4 Previous Clinical Trials
222 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a man aged 45 or older.My breast cancer is in an early stage, but larger than 2 cm.I have been diagnosed with prostate cancer.I have had cancer other than skin cancer in the last 3 years.My prostate cancer has a Gleason score of 7 or is intermediate risk.My prostate cancer is found in 3 or fewer spots, matching my MRI results.You can handle being put to sleep or given medication to relax during the procedure.Your doctor thinks that you will live for at least 5 years.My breast cancer is in an early stage, but it is growing.My cancer does not have any tumors larger than 2cm.I am a man aged 45 or older.My prostate cancer has a Gleason score of 7 or is intermediate risk Gleason 6.Your doctor thinks you have a good chance of living for 5 years or more.
Research Study Groups:
This trial has the following groups:- Group 1: Single arm study
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
California
Arizona
How old are they?
18 - 65
What site did they apply to?
Mayo Clinic in Minnesota
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
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