Clinical trial · Interventional
Laser Based Focal Ablation of Low Grade Prostate Cancer
A Pilot Study to Evaluate Magnetic Resonance Thermal Image-guided Laser-Induced Interstitial Thermal Therapy for Focal Ablation of Prostate Cancer
NCT01192438CI-TRIAL-00014113completedN/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 purpose of this study is to evaluate the safety of MRI-guided laser-induced thermal therapy of biopsy confirmed low-risk prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Low Grade Prostate Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laser-based thermotherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Procedure/surgery
- interventionNames
- Procedure: Laser-based thermotherapy
Primary outcomes (1)
- measure
- Number of patients with adverse events
- timeFrame
- Within 6 months of the procedure
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 or less * A minimum of 12 biopsy cores sampled during diagnostic biopsy * Three or fewer biopsy cores with prostate cancer * No single biopsy core with greater than 50% of tumor involvement * A radiographically visible prostate lesion on MRI with concordance to biopsy sextant * A documented Karnofsky performance status of at least 70 * Estimated survival of 20 years or greater, as determined by treating physician * Ability to give informed consent Exclusion Criteria: * Previous surgery, radiation, or androgen deprivation therapy for prostate cancer * Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI * History of previous pelvic radiation * Severe lower urinary tract symptoms as measured by an International Prostate Symptom Score (IPSS) of 20 or greater. (See Appendix A) * History of other primary non-skin malignancy within previous three years
References
Publications (0)
Data not yet available
No reference posted for this study.