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

The University of Chicago

Status

Completed

Conditions

Stage II Prostate Carcinoma

Stage I Prostate Cancer

Treatments

Procedure: magnetic resonance imaging

Device: Visualase Thermal Therapy

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01792024

12-1841

NCI-2013-00404 (Registry Identifier)

R21CA173751 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This phase II trial studies how well magnetic resonance (MR)-guided laser interstitial thermal therapy works in treating patients with prostate cancer. Laser therapy uses intense, narrow beams of light to cut and destroy tissue and may help treat prostate cancer

Full description

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.

Enrollment

27 patients

Sex

Male

Ages

45+ years old

Volunteers

No Healthy Volunteers

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