Primary Malignant Neoplasm of Prostate (Diagnosis) Clinical Trial
Official title:
MRI-Guided Cryoablation for Focal Native Prostate Cancer
NCT number | NCT04797039 |
Other study ID # | 20-003822 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | December 1, 2020 |
Est. completion date | December 2030 |
The purpose of this research is to collect data about the MRI cryoablation procedure your doctor(s) would normally perform in order to treat the participants focal prostate cancer and to evaluate the participants condition after the participants treatment is performed. Participants have been asked to take part in this research because the participants have been diagnosed with prostate cancer and scheduled to have an ablation procedure.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 2030 |
Est. primary completion date | December 2030 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 30 Years to 100 Years |
Eligibility | Inclusion Criteria: - Patients with "biopsy proven" Gleason7 prostate cancer referred to Urology and/or Interventional Radiology for treatment - Surgery and/or Radiation is not a desirable alternative therapy at the time of enrollment - Tumor size is < 2 cm at its largest diameter - Tumor does not encompass the rectal wall or external urethral sphincter - Patient is able to undergo MRI Exclusion Criteria: • |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Technical success of the MR-guided cryoablation | Determine the technical success of the MR-guided cryoablation as measured by complete target lesion ablation. | Will assess for 5 years with interval assessment each year | |
Primary | Safety of the MR-guided cryoablation | Determine safety of the MR-guided cryoablation using continuous MR imaging during the procedure. | Will assess for 5 years with interval assessment each year | |
Primary | Examine short term tumor recurrence | Examine short term tumor recurrence over 6 months with contrast enhanced MRI and as required MR or U/S guided biopsy of prostate bed if PSA biochemical recurrence. | Will assess for 5 years with interval assessment each year | |
Secondary | MR procedure time. | We will examine the time for each step in the process to create a stream-lined process and minimize MR procedure time. | Will assess for 5 years with interval assessment each year |