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

Stage I Prostate Cancer Clinical Trial

Official title:

Phase II Evaluation of MR-Guided Laser Induced Interstitial Thermal Therapy (LITT) for Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01792024
• Other study ID #: 12-1841
• Secondary ID: NCI-2013-00404R2
• Status: Completed
• Phase: N/A
• First received: February 12, 2013
• Last updated: February 13, 2018
• Start date: January 28, 2013
• Est. completion date: September 16, 2015

Study information

• Verified date: February 2018
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: September 16, 2015
• Est. primary completion date: September 16, 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years and older

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

Related Conditions & MeSH terms

• Prostatic Neoplasms
• Stage I Prostate Cancer
• Stage II Prostate Carcinoma

Intervention

Device:
• Visualase Thermal Therapy
MR guided laser ablation of prostate cancer

Procedure:
• magnetic resonance imaging
Undergo MR-guided LITT

Locations

Country	Name	City	State
United States	University of Chicago Comprehensive Cancer Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Undetectable Cancer on MRI-guided Biopsy of Ablation Zone Following Treatment	The primary study end point was the number of patients with no cancer on MRI guided biopsy of the ablation zone at 3 months.	At 3 months after ablation
Secondary	The Number of Patients With Biopsy Cancer of the Treatment Zone	A systematic 12-core biopsy was performed at 1 year and the number of patients with biopsy cancer was counted.	At 12 months
Secondary	The Total Number of Patients With Any Adverse Events Related to the Treatment	Treatment-related toxicity measured by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0	1,3, and 12 month after treatment and up to 12 months
Secondary	Quality of Life in Terms of Urinary and Sexual Function in the Year Following Treatment Assessed Using the International Prostate Symptom Score (IPSS)	International Prostate Symptom Score (IPSS) measures urinary symptoms and continence and it ranged 0 to 35. Lower values are considered better outcome.	At 1,3 and 12 months
Secondary	Quality of Life in Terms of Urinary and Sexual Function in the Year Following Treatment Assessed Using Sexual Health Inventory in Men (SHIM)	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.	At 1,3 and 12 months