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Procedure
Focal Cryoablation for Prostate Cancer
Phase 2
Recruiting
Led By Justin Gregg, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through completion an average of 1 year.
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether using cryotherapy to treat only the part of the prostate containing cancer is effective in controlling prostate cancer.
Who is the study for?
Men with intermediate-risk prostate cancer who have a single focus of disease visible on MRI and confirmed by biopsy, without evidence of spread beyond the prostate. They must be able to undergo MRI, have not had previous treatments for prostate cancer or certain prostate surgeries, and are willing to follow study procedures.
What is being tested?
The trial is testing focal cryotherapy, which freezes only the part of the prostate with cancer. It's compared against standard care. Participants will also complete quality-of-life questionnaires to assess how treatments affect their well-being.
What are the potential side effects?
Focal cryotherapy may cause discomfort or pain at the treatment site, urinary issues like incontinence or irritation, sexual dysfunction, and potentially damage surrounding tissues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through completion an average of 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through completion an average of 1 year.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Quality-of-life Questionnaires
Awards & 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: Focal therapy TreatmentExperimental Treatment3 Interventions
Cryoablation is a procedure in which special needles are inserted into the tumor site.
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Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,068 Previous Clinical Trials
1,802,809 Total Patients Enrolled
87 Trials studying Prostate Cancer
28,598 Patients Enrolled for Prostate Cancer
Philanthropic SourcesUNKNOWN
Justin Gregg, MDPrincipal Investigatorjrgregg@mdanderson.org
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your doctor thinks that your injury can be treated with cryotherapy.You have undergone a prostate procedure in the past, such as TURP or other treatments to improve urine flow.It's okay if you have small GGG 1 diseases in areas other than the treated area, as long as they are 6mm or smaller.You have received any previous treatments for prostate cancer, such as radiation therapy, hormonal treatment, biologic therapy, or chemotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: Focal therapy Treatment
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.
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