Optic fiber of 300um will be inserted at a distance of 8-10mm from the urethra. Each ablation lasts 6 minutes. Each fiber ablates at an energy of 1800J with a power of 2-3W. Treatment lasts for about 30 minutes.

Prostate Cancer

The intervention will take place in an ambulatory setting of the interventional radiology department using the combined Echolaser XVG system. The treatment consists of a local anesthesia to the perineal region. Within each needle, an optic fiber of 300um will be inserted. Each ablation lasts 6 minutes and each fiber ablates 1800J at a power of 2-3W. At the end of the ablation there is a pull-back of about 1cm from the original ablation location. According to the dimension of the middle lobe of the prostate, multiple pullbacks can be used. The total ablation is 3600J for 2 fibers (1800J/ fiber) at the power of 2-3W for a total duration of about 30minutes. At the end of the treatment, a 20mg bollous of i.v. corticosteriods () is given for anti-edema and anti-inflammatory effects. Antibiotic therapy (Cirpofloxacin 500mg and gastroprotective therapy is given for 5 days. After an adequate amount of time for observation, the patient is dismissed.

Procedure/Surgery: Transperineal Focal Laser Ablation (TPLA)

Italian Registry for Focal Prostate Cancer Ablation

Policlinico Tor Vergata (PTV) Foundation: Department di Biomedicine and Prevention

Focal Laser Ablation for the Treatment of Focal Low-Intermediate Risk Prostate Cancer

Short-term Efficacy of Transperineal Laser Ablation (TPLA) With Image Fusion and Multi-parametric (mpMRI) Follow-up in Focal Low-intermediate Risk Prostate Cancer: Interventional Pilot Study

Cancer control defined as the percentage of patients with disease free survival according to the pathological MR-guided biopsy results in a 5 year period.

Evaluation of the post-procedural complications by mpMRI. In particular damage to neuro-vascular bundles, seminal vescicles and peri-prostatic fat will be checked.

Evaluation of multi-parametric MRI of the prostate and evaluate the response to focal laser ablation treatment for focal low-intermediate prostate cancer by biopsy.

Create an international registry to assess long-term effectiveness of transperineal laser ablation for focal prostate cancer, to assess functional outcomes, to assess safety, to determine baseline patient characteristics, to collect information on possible differences between centres applying treatment of transperineal laser ablation and to explore the optimal treatment indications and possible limitations. It an international prospective observational registry in which data is recorded of patients who are treated with transperineal laser ablation for low-intermediate risk focal prostate cancer.

Guglielmo Manenti

Principal Investigator

University of Rome Tor Vergata

Patients will have a standard of care MRI, then consent to study participation and have an upright MRI.

Patients will consent to participate in the study, then do two MRIs in random order.

Prostate Biopsy Cores and/or Punch Cores from Radical Prostatectomy Specimen

Elevated PSA

Elevated Prostate Specific Antigen

Women do not have prostates and this is a study of prostate health

Indomitable Magnetic Resonance Imaging Scanner, magnetic resonance imaging using 0.6 T strength

Upright MRI

Standard MRI

Icahn School of Medicine at Mount Sinai

Upright MRI for Prostate Cancer Screening

Feasibility and Efficacy of Upright MP - MRI for Prostate Cancer Screening

To compare performance characteristics of Upright MP-MRI versus 3T MP-MRI in detecting clinically significant PCa and PCa in general.

Claustrophobic Questionnaire (CLQ) is a 46 item instrument, each item score on a likert scale from 1-5, full scale from 36 to 180, with higher score indicating more anxiety.

NCCN Distress Thermometer is a visual scale - full scale from 0-10, higher score indicating higher level of distress

Magnetic Resonance Imaging-Anxiety Questionnaire (MRI-AQ) is a 15 item instrument, each item score on a likert scale from 1 to 4, full scale range from 15 to 66, with higher score indicating higher degree of anxiety.

To compare the diagnostic yield of using MP-MRI with thresholds PSA density used for detecting prostate cancer.

Number of correctly identified side of prostate unaffected in men with pathological disease

Ashutosh Kumar Tewari

Professor

The Fonar Corporation

Patients will have both a standard MRI and an Upright MRI to image potential prostate lesions. The order of the MRIs will be random, and the second will be done within two weeks of the first.

hemospermia/تبول لاإرادي

Focal Laser Ablation for the Treatment of Focal Low-Intermediate Risk Prostate Cancer

Upright MRI for Prostate Cancer Screening

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