Laser Based Focal Ablation of Low Grade Prostate Cancer

The University of Chicago

Status: Completed

Conditions: Low Grade Prostate Cancer

Treatments: Procedure: Laser-based thermotherapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01192438

09-364A

Details and patient eligibility

About

The purpose of this study is to evaluate the safety of MRI-guided laser-induced thermal therapy of biopsy confirmed low-risk prostate cancer.

Enrollment: 9 patients

Sex: Male

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male, 45 years of age or older
• Diagnosis of prostate adenocarcinoma
• Clinical stage T1c or T2a
• Gleason score of 7 or less
• A minimum of 12 biopsy cores sampled during diagnostic biopsy
• Three or fewer biopsy cores with prostate cancer
• No single biopsy core with greater than 50% of tumor involvement
• A radiographically visible prostate lesion on MRI with concordance to biopsy sextant
• A documented Karnofsky performance status of at least 70
• Estimated survival of 20 years or greater, as determined by treating physician
• Ability to give informed consent

Exclusion criteria

• Previous surgery, radiation, or androgen deprivation therapy for prostate cancer
• Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI
• History of previous pelvic radiation
• Severe lower urinary tract symptoms as measured by an International Prostate Symptom Score (IPSS) of 20 or greater. (See Appendix A)
• History of other primary non-skin malignancy within previous three years

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Procedure/surgery

Experimental group

Treatment:

Procedure: Laser-based thermotherapy