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Procedure

MR-Guided Cryoablation for Recurrent 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
Patients with biopsy proven soft tissue tumor recurrences of prostate fossa
Tumor size is less than 5 cm at its largest diameter
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study Summary

This trial will test whether MR-guided cryoablation can effectively shrink prostate tumors that have come back.

Who is the study for?
This trial is for adults with prostate cancer that has come back and shows up in the area where the prostate used to be. The tumor must be smaller than 5 cm, not involve certain areas like the rectal wall, and patients should be healthy enough for MRI scans. It's aimed at those who can't have or don't want surgery right now, and whose cancer hasn't responded to or isn't suitable for radiation therapy.Check my eligibility
What is being tested?
The study is testing MR-guided cryoablation—a way of freezing tumors using magnetic resonance imaging to guide the process—to see if it's effective in treating prostate cancer recurrences located where the prostate was previously removed.See study design
What are the potential side effects?
While specific side effects are not listed here, cryoablation procedures may generally include risks such as pain at the treatment site, swelling, bruising, infection risk, tissue damage around treated areas including nerves or blood vessels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My prostate cancer has returned and is confirmed by a biopsy.
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My tumor is smaller than 5 cm across.
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My tumor does not involve the rectal wall or the external urethral sphincter.
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Surgery is not a good option for my condition right now.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluation of target lesion at 3-6, 12, 24, and 36 month imaging follow-up

Trial Design

1Treatment groups
Experimental Treatment
Group I: MR-guided cryoablation (freezing of tissue and/or tumors)Experimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,227 Previous Clinical Trials
3,771,468 Total Patients Enrolled
34 Trials studying Prostate Cancer
8,388 Patients Enrolled for Prostate Cancer
David Woodrum, MD, PhDPrincipal InvestigatorMayo Clinic
4 Previous Clinical Trials
32 Total Patients Enrolled
1 Trials studying Prostate Cancer
10 Patients Enrolled for Prostate Cancer

Media Library

MR-guided cryoablation (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT01727284 — N/A
Prostate Cancer Research Study Groups: MR-guided cryoablation (freezing of tissue and/or tumors)
Prostate Cancer Clinical Trial 2023: MR-guided cryoablation Highlights & Side Effects. Trial Name: NCT01727284 — N/A
MR-guided cryoablation (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01727284 — N/A

Frequently Asked Questions

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

Are the qualifications for this study compatible with my background?

"This medical study seeks 100 individuals aged 30 to 100 who have a prostate tumor. To be eligible for inclusion, potential participants must also satisfy the following conditions: Surgery is not an option at enrollment; radiation therapy has been ineffective or can be delayed safely; maximum diameter of the tumor is less than 5 cm; no encasement of rectal wall and/or external urethral sphincter present, and performance status should preferably be ECOG 2 or better in adults."

Answered by AI

Is the enrollment for this medical experiment allowing those below fifty-five years of age to participate?

"To partake in this clinical trial, patients must be between 30 and 100 years of age. There are over 160 trials for those below the legal consenting age and 909 studies for individuals above 65."

Answered by AI

Are individuals still being enrolled into this experiment?

"Current information available on clinicaltrials.gov suggests that this experimental protocol is actively seeking participants, having been initially published in December 2012 and revised recently in February 2022."

Answered by AI

How many individuals have enrolled in this clinical examination thus far?

"Affirmative. According to materials published on clinicaltrials.gov, this trial that was initially posted in December 2012 is actively searching for patients. Approximately 100 people will be accepted from a single location."

Answered by AI
~6 spots leftby Oct 2024