Clinical trial · Interventional
MR-Guided Laser Interstitial Thermal Therapy in Treating Patients With Prostate Cancer
Phase II Evaluation of MR-Guided Laser Induced Interstitial Thermal Therapy (LITT) for Prostate Cancer
NCT01792024CI-TRIAL-00032043completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage II Prostate Carcinoma | Prostate Carcinoma | CURATED_BROADER | 0.78 |
| Stage I Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| magnetic resonance imaging | Procedure | — | UNRESOLVED |
| Visualase Thermal Therapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (LITT)
- description
- Patients undergo Magnetic Resonance imaging (MR) guided laser thermal therapy with Visualase Thermal Therapy device.
- interventionNames
- Device: Visualase Thermal Therapy
- Procedure: magnetic resonance imaging
Primary outcomes (1)
- measure
- Number of Participants With Undetectable Cancer on MRI-guided Biopsy of Ablation Zone Following Treatment
- timeFrame
- At 3 months after ablation
- description
- 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 outcomes (4)
- measure
- The Number of Patients With Biopsy Cancer of the Treatment Zone
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.