Clinical trial · Interventional
MRI Targeted Focal Laser Thermal Therapy of Prostate Cancer
Phase 1 Study of MRI Targeted Focal Laser Thermal Therapy of Prostate Cancer
NCT01094665CI-TRIAL-00032008FLTT002completedN/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 objective of this study is to evaluate the safety and feasibility of Magnetic Resonance Image (MRI) guided focal prostate cancer laser thermal ablation in males, ages 40-80 with biopsy confirmed early clinical stage prostate cancer (T1c or T2a) with an identifiable lesion on mutliparametric MRI, with a Prostate Specific Antigen (PSA) of \< 15ng/ml, who have not yet undergone pelvic radiation or hormonal deprivation therapy.
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 |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI Targeted Focal Laser Thermal Therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Focal Laser Thermal Therapy
- description
- Thermal therapy delivered to lesion visible on MRI.
- interventionNames
- Procedure: MRI Targeted Focal Laser Thermal Therapy
Primary outcomes (1)
- measure
- Transrectal Ultrasound Guided Prostate Biopsy
- timeFrame
- 4 Months Post Treatment
- description
- A 12 core biopsy, plus 2 cores aimed at the ablated lesion will then be preformed to verify the oncological effectiveness of the treatment.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Men 45-80 years of age; * Histologically proven prostate carcinoma; * Prostate cancer clinical stage T1c and T2a * Prostate MRI must confirm area suspicious for cancer in the sector of the positive biopsy; * Prostate specific antigen (PSA) level less than 15 ng/mL * 12 cores biopsy, with histologically proven prostate carcinoma, in the suspicious region on MRI. * IPSS and IIEF complete prior to procedure * Life expectancy of greater than 5 years, based on co-morbidity not related to prostate cancer. Exclusion Criteria: * Medically unfit for focal therapy of the prostate * Patients who are unwilling or unable to give informed consent; * Patients who have received androgen suppression therapy * Patients who have received or are receiving chemotherapy for prostate carcinoma; * Patients previously treated with surgery to the prostate (traditional, endoscopic or minimally invasive including HIFU, TUNA, RITA, microwave, TURP, cryotherapy or any curative treatment * Patients who have undergone radiation therapy for prostate cancer or to the pelvis * Any condition, or history of illness or surgery that, in the opinion of the Investigator, might confound the results of the study or pose additional risks to the patient (e.g. significant cardiovascular conditions or allergies); * Patients with a history of non compliance with medical therapy and/or medical recommendations; * Patients who are unwilling or unable to complete the patient self-assessment questionnaires; * Chronic or acute prostatitis, neurogenic bladder, urinary tract infection, sphincter abnormalities, or any other symptom that prevents normal micturition. * Patients who have participated in a clinical study and/or received treatment with an investigational treatment and/or product within the past 90 days; * If the patient is unable to undergo regional anesthesia * Patients with contraindication to MRI (i.e. pacemaker, hip prosthesis, severe claustrophobia, brain aneurysm clip, allergy to MRI contrast agent) * Any condition, or history of illness that, in the opinion of the investigator will confound or increase the patient risk during the study
References
Publications (0)
Data not yet available
No reference posted for this study.