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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-00404 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| R21CA173751 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (LITT) | Experimental | Patients undergo Magnetic Resonance imaging (MR) guided laser thermal therapy with Visualase Thermal Therapy device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visualase Thermal Therapy | Device | MR guided laser ablation of prostate cancer |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| The Total Number of Patients With Any Adverse Events Related to the Treatment |
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Inclusion Criteria:
Clinical characteristics:
No evidence of metastatic disease based on National Comprehensive Cancer Network (NCCN) guidelines:
Biopsy requirements:
Imaging requirements:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Aytekin Oto | University of Chicago Comprehensive Cancer Center | Principal Investigator |
| Scott Eggener, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637-1470 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (LITT) | Patients undergo MR-guided laser ablation of prostate cancer Visualase Thermal Therapy: MR guided laser ablation of prostate cancer magnetic resonance imaging: Undergo MR-guided LITT |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (LITT) | Patients undergo MR-guided laser ablation of prostate cancer Visualase Thermal Therapy: MR guided laser ablation of prostate cancer magnetic resonance imaging: Undergo MR-guided LITT |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | At 3 months after ablation |
|
|
1,3 and 12 months after treatment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment (LITT) | Patients undergo MR-guided laser ablation of prostate cancer Visualase Thermal Therapy: MR guided laser ablation of prostate cancer magnetic resonance imaging: Undergo MR-guided LITT |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding per rectum | Injury, poisoning and procedural complications | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic reaction | Immune system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Aytekin Oto | University of Chicago | 773-834-7424 | aoto@radiology.bsd.uchicago.edu |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| magnetic resonance imaging | Procedure | Undergo MR-guided LITT |
|
|
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 |
| 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 |
| 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 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| 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. | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | 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. | Posted | Median | Full Range | units on a scale | 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. | Posted | Median | Full Range | units on a scale | At 1,3 and 12 months |
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|
| 0 |
| 27 |
| 2 |
| 27 |
| 20 |
| 27 |
| Fever | General disorders | Systematic Assessment |
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| Erectile dysfunction | Reproductive system and breast disorders | Systematic Assessment |
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| Hematuria | Renal and urinary disorders | Systematic Assessment |
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| Renal and urinary disorders - Other, specify | Renal and urinary disorders | Systematic Assessment |
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| Scrotal pain | Reproductive system and breast disorders | Systematic Assessment |
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| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Urinary frequency | Renal and urinary disorders | Systematic Assessment |
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| urinary incontinence | Renal and urinary disorders | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | Systematic Assessment |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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