Focal Laser Ablation of Low to Intermediate Prostate Cancer Tumors

Mayo Clinic

Status

Active, not recruiting

Conditions

Stage I Prostate Cancer AJCC v8

Localized Prostate Carcinoma

Prostate Adenocarcinoma

Prostate Cancer

Stage II Prostate Cancer AJCC v8

Treatments

Procedure: Focal laser ablation of the prostate

Study type

Interventional

Funder types

Other

Identifiers

NCT02600156

14-005500

Details and patient eligibility

About

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.

Full description

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.

Enrollment

7 patients

Sex

Male

Ages

45+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Male, 45 years of age or older.
Diagnosis of prostate adenocarcinoma.
Clinical stage T1c or T2a.
Gleason score of 7 (3+4 or 4+3) or Intermediate risk Gleason 6
PSA less than or equal to 20 ng/mL
Three or fewer biopsy locations with prostate cancer which correlate with MRI findings.
No lesion > or = 2cm
One, two, or three tumor suspicious regions identified on multiparametric MRI
No definite radiographic indication of extra-capsular extension.
Estimated survival of 5 years or greater, as determined by treating physician.
Tolerance for anesthesia/sedation.
Ability to give informed consent.

Exclusion Criteria

Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI.
History of other primary non-skin malignancy within previous three years.