Trial record 1 of 3 for:
eggener
MR-Guided Laser Interstitial Thermal Therapy in Treating Patients With Prostate Cancer
This study is currently recruiting participants.
Verified February 2013 by University of Chicago
Sponsor:
University of Chicago
Collaborator:
Information provided by (Responsible Party):
Aytekin Oto, MD, University of Chicago
ClinicalTrials.gov Identifier:
NCT01792024
First received: February 12, 2013
Last updated: NA
Last verified: February 2013
History: No changes posted
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Stage I Prostate Cancer Stage IIA Prostate Cancer |
Procedure: laser interstitial thermal therapy Procedure: magnetic resonance imaging Procedure: quality-of-life assessment |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | PHASE II EVALUATION OF MR-GUIDED LASERINDUCED INTERSTITIAL THERMAL THERAPY (LITT) FOR PROSTATE CANCER |
Resource links provided by NLM:
Further study details as provided by University of Chicago:
Primary Outcome Measures:
- Undetectable cancer on MRI-guided biopsy of ablation zone following treatment [ Time Frame: At 3 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Oncologic efficacy following treatment based on biopsy of the treatment zone [ Time Frame: At 12 months ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 27 |
| Study Start Date: | January 2013 |
| Estimated Primary Completion Date: | May 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment (LITT)
Patients undergo MR-guided LITT.
|
Procedure: laser interstitial thermal therapy
Undergo MR-guided LITT
Procedure: magnetic resonance imaging
Undergo MR-guided LITT
Other Names:
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
|
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| Ages Eligible for Study: | 45 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01792024
Locations
| United States, Illinois | |
| University of Chicago Comprehensive Cancer Center | Recruiting |
| Chicago, Illinois, United States, 60637-1470 | |
| Contact: Aytekin Oto 773-834-7424 aoto@radiology.bsd.uchicago.edu | |
| Principal Investigator: Aytekin Oto | |
Sponsors and Collaborators
University of Chicago
Investigators
| Principal Investigator: | Aytekin Oto | University of Chicago Comprehensive Cancer Center |
| Principal Investigator: | Scott Eggener, MD | University of Chicago |
More Information
No publications provided
| Responsible Party: | Aytekin Oto, MD, Principal Investigator, University of Chicago |
| ClinicalTrials.gov Identifier: | NCT01792024 History of Changes |
| Other Study ID Numbers: | 12-1841, NCI-2013-00404 |
| Study First Received: | February 12, 2013 |
| Last Updated: | February 12, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013