Focal Laser Ablation of Low to Intermediate Prostate Cancer Tumors
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|ClinicalTrials.gov Identifier: NCT02600156|
Recruitment Status : Recruiting
First Posted : November 9, 2015
Last Update Posted : April 27, 2021
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Procedure: Focal laser ablation of the prostate||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study to Evaluate Magnetic Resonance Thermal Image-Guided Focal Laser Ablation of Low to Intermediate Prostate Cancer Tumors|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
Experimental: Single arm study
MR guided focal laser ablation of prostate cancer using the Visualase Thermal Therapy System.
Procedure: Focal laser ablation of the prostate
MR guided laser ablation of the focal prostatic lesion which has been identified by MRI and biopsy prior to ablation.
Other Name: Visualase Laser Ablation
- Success rate [ Time Frame: 3 years ]To evaluate the procedural success rate of using the MR-guided laser ablation to target, access, thermally monitor, and focally ablate MR-visible prostate cancer lesions.
- Incidence of treatment emergent adverse events [ Time Frame: 3 years ]To evaluate patient-related safety by monitoring short and long-term complications related to the procedure such as but not limited to incontinence, impotence, and urethral fistulas.
- Short- and mid-term ablative success [ Time Frame: 3 years ]To obtain preliminary data on ablative success using longitudinal MR imaging assessment of treated areas.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02600156
|Contact: Jennifer Murphy||507-538-0540||Murphy.Jennifer@mayo.edu|
|Contact: Desirae Howe-Clayton||507-255-0111||Howe.Desirae@mayo.edu|
|United States, Minnesota|
|Mayo Clinic in Minnesota||Recruiting|
|Rochester, Minnesota, United States, 55905|
|Contact: Jennifer Murphy 507-538-0540 Murphy.Jennifer@mayo.edu|
|Principal Investigator: David A. Woodrum, M.D., Ph.D|
|Principal Investigator:||David Woodrum, MD, PhD||Mayo Clinic|