Clinical trial NCT01792024: MR-Guided Laser Interstitial Thermal Therapy in Treating Patients With Prostate Cancer
Official title: Phase II Evaluation of MR-Guided Laser Induced Interstitial Thermal Therapy (LITT) for Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stage I Prostate Cancer
Stage II Prostate Carcinoma
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-02-15
Enrollment: 27
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Undetectable Cancer on MRI-guided Biopsy of Ablation Zone Following Treatment
timeFrame: At 3 months after ablation
Secondary outcomes:
measure: The Number of Patients With Biopsy Cancer of the Treatment Zone
timeFrame: At 12 months
measure: The Total Number of Patients With Any Adverse Events Related to the Treatment
timeFrame: 1,3, and 12 month after treatment and up to 12 months
measure: Quality of Life in Terms of Urinary and Sexual Function in the Year Following Treatment Assessed Using the International Prostate Symptom Score (IPSS)
timeFrame: At 1,3 and 12 months
measure: Quality of Life in Terms of Urinary and Sexual Function in the Year Following Treatment Assessed Using Sexual Health Inventory in Men (SHIM)
timeFrame: At 1,3 and 12 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Comprehensive Cancer Center
state: Illinois
Study officials:
affiliation: University of Chicago Comprehensive Cancer Center
name: Aytekin Oto
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chicago
name: Scott Eggener, MD
role: PRINCIPAL_INVESTIGATOR
References: