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

Not Applicable

Completed

Interventions: Device: Visualase Thermal Therapy
Procedure: magnetic resonance imaging

Brief Summary: 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

Detailed 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Treatment (LITT)	Visualase Thermal Therapy	Patients undergo Magnetic Resonance imaging (MR) guided laser thermal therapy with Visualase Thermal Therapy device.
Treatment (LITT)	magnetic resonance imaging	Patients undergo Magnetic Resonance imaging (MR) guided laser thermal therapy with Visualase Thermal Therapy device.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Undetectable Cancer on MRI-guided Biopsy of Ablation Zone Following Treatment	At 3 months after ablation	The primary study end point was the number of patients with no cancer on MRI guided biopsy of the ablation zone at 3 months.

Secondary Outcome Measures

Name	Time	Method
The Number of Patients With Biopsy Cancer of the Treatment Zone	At 12 months	A systematic 12-core biopsy was performed at 1 year and the number of patients with biopsy cancer was counted.
Quality of Life in Terms of Urinary and Sexual Function in the Year Following Treatment Assessed Using Sexual Health Inventory in Men (SHIM)	At 1,3 and 12 months	Sexual Health Inventory Score in Men (SHIM) measures sexual health and erectile function and it ranged 1 to 25. Lower values are considered better outcome.
Quality of Life in Terms of Urinary and Sexual Function in the Year Following Treatment Assessed Using the International Prostate Symptom Score (IPSS)	At 1,3 and 12 months	International Prostate Symptom Score (IPSS) measures urinary symptoms and continence and it ranged 0 to 35. Lower values are considered better outcome.
The Total Number of Patients With Any Adverse Events Related to the Treatment	1,3, and 12 month after treatment and up to 12 months	Treatment-related toxicity measured by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0

Locations (1): University of Chicago Comprehensive Cancer Center
🇺🇸
Chicago, Illinois, United States