MR-Guided Laser Interstitial Thermal Therapy in Treating Patients With Prostate Cancer

PRIMARY OBJECTIVES:

I. To evaluate the oncologic efficacy of laster interstitial thermal therapy (LITT) with
primary endpoint of undetectable cancer on magnetic resonance imaging (MRI)-guided biopsy of
treatment zone at 3 months following treatment.

SECONDARY OBJECTIVES:

I. To evaluate oncologic efficacy at 12 months following treatment based on biopsy of the
treatment zone.

II. To determine treatment-related safety and toxicity. III. To longitudinally assess urinary
and sexual function in the year following treatment.

OUTLINE:

Patients undergo MR-guided LITT.

After completion of study treatment, patients are followed up at 1, 3, and 12 months.

Inclusion Criteria:

- Clinical characteristics:

- Stage T1c or T2a

- Prostate-specific antigen (PSA) < 15 ng/ml or PSA density (PSA divided by
prostate volume in cubic centimeters) < 0.15 ng/ml^3

- No evidence of metastatic disease based on National Comprehensive Cancer Network
(NCCN) guidelines:

- Bone scan if PSA > 20 ng/ml and clinical stage T1c

- Bone scan if PSA > 10 ng/ml and clinical stage T2

- Biopsy requirements:

- Gleason score 7 or less

- 25% or fewer biopsies with cancer

- At least 12 biopsy cores of the prostate

- Within 12 months of treatment

- Imaging requirements:

- Up to 2 visible magnetic resonance (MR) lesion(s) concordant with sextant of
biopsy-detected cancer(s)

- MRI within 6 months of treatment

- Karnofsky performance status of at least 70

- General health is suitable to undergo the planned minimally invasive procedures

- Risks, benefits, and alternatives discussed with informed consent given

Exclusion Criteria:

- Previous treatment of prostate cancer with luteinizing hormone releasing hormone
(LHRH) agonist/antagonist, chemotherapy, surgery, or radiation

- Presence of 3 or more visible lesions on MRI

- High suspicion of seminal vesicle invasion or lymph node metastases on MRI

- Unable to tolerate MRI (medical device, foreign body, claustrophobia, body habitus, or
other)

- Renal insufficiency with estimated glomerular filtration rate (eGFR) < 30 ml/min/body
surface area (BSA) based on Modification in Diet Renal Disease equation; inability to
safely receive gadolinium contrast for MRI

- History of prior pelvic surgery with surgical clips remaining in situ (e.g., bladder,
bowel, internal pelvic organs) that compromise MRI image quality

- Other serious illnesses involving the cardiac, respiratory, central nervous system
(CNS), or hepatic organ systems, which would preclude study completion or impede the
determination of causality of any complications experienced during the conduct of this
study