Overview

This trial is active, not recruiting.

Conditions stage i prostate cancer, stage ii prostate carcinoma
Treatments visualase thermal therapy, magnetic resonance imaging, quality-of-life assessment
Phase phase 2
Sponsor University of Chicago
Collaborator National Cancer Institute (NCI)
Start date January 2013
End date February 2017
Trial size 27 participants
Trial identifier NCT01792024, 12-1841, NCI-2013-00404

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients undergo MR-guided laser ablation of prostate cancer
visualase thermal therapy laser interstitial thermal therapy
MR guided laser ablation of prostate cancer
magnetic resonance imaging MRI
Undergo MR-guided LITT
quality-of-life assessment quality of life assessment
Ancillary studies

Primary Outcomes

Measure
Undetectable cancer on MRI-guided biopsy of ablation zone following treatment
time frame: At 3 months

Secondary Outcomes

Measure
Oncologic efficacy following treatment based on biopsy of the treatment zone
time frame: At 12 months
Rates and grades of treatment-related toxicity measured by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0
time frame: Up to 12 months
Quality of life in terms of urinary and sexual function in the year following treatment assessed using the International Prostate Symptom Score (IPSS) and Sexual Health Inventory in Men (SHIM)
time frame: Up to 12 months

Eligibility Criteria

Male participants at least 45 years old.

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

Additional Information

Official title PHASE II EVALUATION OF MR-GUIDED LASERINDUCED INTERSTITIAL THERMAL THERAPY (LITT) FOR PROSTATE CANCER
Principal investigator Aytekin Oto
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University of Chicago.