MRI-Guided Cryoablation for Focal Native Prostate Cancer

Primary Malignant Neoplasm of Prostate (Diagnosis) Clinical Trial

Official title:

MRI-Guided Cryoablation for Focal Native Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04797039
• Other study ID #: 20-003822
• Status: Recruiting
• Start date: December 1, 2020
• Est. completion date: December 2030

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: Desirae Howe-Clayton
• Phone: 507-255-0111
• Email: howe.desirae[@]mayo.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

The purpose of this study is to evaluate MR-guided cryoablation of biopsy proven prostate tumors using the Galil MRI-compatible cryoablation system. The system has been approved by the United States Food and Drug Administration (FDA) for soft tissue ablation and has been utilized successfully at Mayo. All procedures will be performed according to approved indications. the investigators wish to monitor the technique and collect data at the participants follow-up visits. The study only collects data about the MRI-guided cryoablation procedure the participants doctor(s) would normally perform in order to treat the participants focal prostate cancer and to evaluate the participants condition after there treatment is performed. The participants doctor will advise the participants when the participants should return for follow-up visits. These visits will be according to the participants doctor's standard of care; usually return visits are at 3-6months, 12 months, 24 months, 36 months, 48 months and 60 months after the procedure, although the participants doctor may ask that the participants return for more frequent visits.

Recruitment information / eligibility

• 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: •

Related Conditions & MeSH terms

• Neoplasms
• Primary Malignant Neoplasm of Prostate (Diagnosis)
• Prostatic Neoplasms

Intervention

Procedure:
• MR guided cryoablation
MR guided cryoablation of focal biopsy proven prostate cancer

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

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