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The primary purpose of this study is to evaluate the feasibility and safety of MRI-guided focal laser ablation (Laser-Induced Interstitial Thermal Therapy, LITT) to treat low-risk native prostate cancer.
The study is being done to evaluate the safety and effectiveness of Magnetic Resonance Imaging (MRI)-guided focal laser therapy with the Visualase Thermal Therapy System to treat low-risk prostate cancer tumors. Unlike surgery or radiotherapy which affects a large portion of the prostate or the entire organ, localized or focal therapy is intended to treat a small portion of tissue in which the cancer has been found by biopsy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm study | Experimental | MR guided focal laser ablation of prostate cancer using the Visualase Thermal Therapy System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Focal laser ablation of the prostate | Procedure | MR guided laser ablation of the focal prostatic lesion which has been identified by MRI and biopsy prior to ablation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Success rate | 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. | 3 years |
| Incidence of treatment emergent adverse events | 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. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Short- and mid-term ablative success | To obtain preliminary data on ablative success using longitudinal MR imaging assessment of treated areas. | 3 years |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| David Woodrum, MD, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Minnesota | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |