Clinical trial · Interventional
Focal Laser Ablation of Low to Intermediate Prostate Cancer Tumors
A Pilot Study to Evaluate Magnetic Resonance Thermal Image-Guided Focal Laser Ablation of Prostate Cancer Tumors
NCT02600156CI-TRIAL-00099183completedN/AClinicalTrials.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)
The primary purpose of this study is to evaluate the feasibility and safety of MRI-guided focal laser ablation (Laser-Induced Interstitial Thermal Therapy, LITT) to treat low-risk native prostate cancer.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Localized Prostate Carcinoma | Prostate Carcinoma | CURATED_BROADER | 0.78 |
| Prostate Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Stage II Prostate Cancer AJCC v8 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Prostate Cancer AJCC v8 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Focal laser ablation of the prostate | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single arm study
- description
- MR guided focal laser ablation of prostate cancer using the Visualase Thermal Therapy System.
- interventionNames
- Procedure: Focal laser ablation of the prostate
Primary outcomes (2)
- measure
- Success rate
- timeFrame
- 3 years
- description
- To evaluate the procedural success rate of using the MR-guided laser ablation to target, access, thermally monitor, and focally ablate MR-visible prostate cancer lesions.
- measure
- Incidence of treatment emergent adverse events
- timeFrame
- 3 years
- description
- To evaluate patient-related safety by monitoring short and long-term complications related to the procedure such as but not limited to incontinence, impotence, and urethral fistulas.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria * Male, 45 years of age or older. * Diagnosis of prostate adenocarcinoma. * Clinical stage T1c or T2a. * Gleason score of 7 (3+4 or 4+3) or Intermediate risk Gleason 6 * PSA less than or equal to 20 ng/mL * Three or fewer biopsy locations with prostate cancer which correlate with MRI findings. * No lesion \> or = 2cm * One, two, or three tumor suspicious regions identified on multiparametric MRI * No definite radiographic indication of extra-capsular extension. * Estimated survival of 5 years or greater, as determined by treating physician. * Tolerance for anesthesia/sedation. * Ability to give informed consent. Exclusion Criteria * Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI. * History of other primary non-skin malignancy within previous three years.
References
Publications (0)
Data not yet available
No reference posted for this study.