Stage II Prostate Carcinoma, Stage I Prostate Cancer
Conditions
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.
Interventions
DEVICEVisualase Thermal Therapy
MR guided laser ablation of prostate cancer
PROCEDUREmagnetic resonance imaging
Undergo MR-guided LITT
Sponsors
National Cancer Institute (NCI)
University of Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
45 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Undetectable Cancer on MRI-guided Biopsy of Ablation Zone Following Treatment | At 3 months after ablation | The primary study end point was the number of patients with no cancer on MRI guided biopsy of the ablation zone at 3 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Patients With Biopsy Cancer of the Treatment Zone | At 12 months | A systematic 12-core biopsy was performed at 1 year and the number of patients with biopsy cancer was counted. |
| The Total Number of Patients With Any Adverse Events Related to the Treatment | 1,3, and 12 month after treatment and up to 12 months | Treatment-related toxicity measured by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 |
| Quality of Life in Terms of Urinary and Sexual Function in the Year Following Treatment Assessed Using the International Prostate Symptom Score (IPSS) | At 1,3 and 12 months | International Prostate Symptom Score (IPSS) measures urinary symptoms and continence and it ranged 0 to 35. Lower values are considered better outcome. |
| Quality of Life in Terms of Urinary and Sexual Function in the Year Following Treatment Assessed Using Sexual Health Inventory in Men (SHIM) | At 1,3 and 12 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 27 |
| Total | 27 |
Baseline characteristics
| Characteristic | Treatment (LITT) |
|---|---|
| Age, Continuous | 62 years |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 27 |
| other Total, other adverse events | 20 / 27 |
| serious Total, serious adverse events | 2 / 27 |
Outcome results
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.
Time frame: At 3 months after ablation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment (LITT) | Number of Participants With Undetectable Cancer on MRI-guided Biopsy of Ablation Zone Following Treatment | 26 Participants |
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.
Time frame: At 1,3 and 12 months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treatment (LITT) | Quality of Life in Terms of Urinary and Sexual Function in the Year Following Treatment Assessed Using Sexual Health Inventory in Men (SHIM) | At 1 month | 19 units on a scale |
| Treatment (LITT) | Quality of Life in Terms of Urinary and Sexual Function in the Year Following Treatment Assessed Using Sexual Health Inventory in Men (SHIM) | At 3 month | 19 units on a scale |
| Treatment (LITT) | Quality of Life in Terms of Urinary and Sexual Function in the Year Following Treatment Assessed Using Sexual Health Inventory in Men (SHIM) | At 12 month | 21 units on a scale |
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.
Time frame: At 1,3 and 12 months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treatment (LITT) | Quality of Life in Terms of Urinary and Sexual Function in the Year Following Treatment Assessed Using the International Prostate Symptom Score (IPSS) | At 1 month | 10 units on a scale |
| Treatment (LITT) | Quality of Life in Terms of Urinary and Sexual Function in the Year Following Treatment Assessed Using the International Prostate Symptom Score (IPSS) | At 3 month | 7 units on a scale |
| Treatment (LITT) | Quality of Life in Terms of Urinary and Sexual Function in the Year Following Treatment Assessed Using the International Prostate Symptom Score (IPSS) | At 12 month | 10 units on a scale |
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.
Time frame: At 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment (LITT) | The Number of Patients With Biopsy Cancer of the Treatment Zone | 3 Participants |
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
Time frame: 1,3, and 12 month after treatment and up to 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment (LITT) | The Total Number of Patients With Any Adverse Events Related to the Treatment | 20 Participants |