Clinical trial: NCT04045756
Section: Alternatives
Subsections: Alternative Treatments

Currently the therapeutic protocol accepted according to the AIO Guidelines 2018 for prostate cancer in patients considered to be at intermediate risk - PGG 2 or 3 consists of radical prostatectomy or external radiotherapy, methods that positively impact both as overall survival and as cancer-specific.
Clinical trial: NCT04045756
Section: Confidentiality
Subsections: Confidentiality Of Personal Data

We inform you that your personal data will be collected and stored electronically and will be used exclusively for scientific research purposes.  
You have the right to know what information will be stored and to update or change incorrect data. Access to these data will be protected by the Investigator (the doctor who follows you during the Study). Regulatory authorities (Ministry of Health), medical staff, monitoring and verification of correct procedures (Independent Ethics Committee) will be able to inspect the archive without the possibility of tracing back to your personal identity.  
The results of the study in which it participates may be published but your identity will always remain secret, in full compliance with the legislation in force in Italy on the protection of personal data D.Lgs.196 dated 30.06.2003 / GDPR679 / 2016.
Clinical trial: NCT04045756
Section: Duration of Study Involvement
Subsections: Interruption Of The Study

Your participation in the study is completely voluntary and you can withdraw at any time and for any reason without having to provide explanations, possibly communicating it to the doctor who follows you for this study.
Clinical trial: NCT04045756
Section: Participant Responsibilities
Subsections: What Is Your Participation In The Studio

If you decide to participate in the Study, you will be evaluated by a multidisciplinary commission according to specific inclusion criteria. If it is suitable, it will be included in the Study. The percutaneous treatment is preceded by a local anesthetic of the perineal region, under ultrasound guidance. At the discretion of the medical team, sedation can be carried out with the assistance of a specialist in Anesthesiology and Resuscitation.  
After identifying the lesion using a trans-rectal ultrasound with the fusion technique of the echo-MR
image, and following the administration of local anesthesia, 1 or 2 guide needles will be inserted (from 21G), in correspondence with the diagnosed neoplastic lesion . In each needle a 300 micron optical fiber will be inserted with a coaxial technique. Following the evaluation of the correct positioning of the fibers, an energy of 1800 J per fiber will be delivered, with a power of 2-5 Watts for a total duration of approximately 15 minutes. Overall, the procedure lasts about 30 minutes on average.  
Your participation does not entail any additional costs. INVESTIGATIONS TO WHICH IT WILL BE SUBMITTED DURING THE STUDY The study foresees the carrying out of the diagnostic investigations described below. Specialist examination with serum PSA and multi-parametric MR prostate (after administration of paramagnetic intravenous contrast agent) at 3-6-12 months.  
Random prostatic biopsy and prostatic fusion biopsy (as usual in clinical practice) at 6 and 12 months.  
Subsequently a specialist visit with PSA tot and free every 6 months for the first 3 years then annually. Repetition of multiparametric prostate MRI and biopsies every 12 months for the first 3 years then every 18 months up to 5 years.
Clinical trial: NCT04045756
Section: Procedures
Subsections: Device In Studio / Experimental Procedure

Focal percutaneous ablative treatment with laser at the diode of the focal prostate tumor, with evaluation of the effectiveness after treatment and in the short-term follow-up, by multi-parametric MR prostate.  
WHAT ARE THE RISKS AND THE SIDE EFFECTS ARISING FROM THE PARTICIPATION IN THE STUDIO Clinical trials (Lindner et al, and Oto et al.) Have demonstrated the short-term efficacy of focal laser ablation provided in the study in low-risk patients.  
No complications have been reported peri-operatively. In the post-operative period, new onset erectile dysfunctions and no significant changes in the main scales of evaluation of male function have been documented: SHIM (Sexual Health Inventory for Men), IIEF (International Index of Erectile Function), AUASS (American Urological Association Symptom Score) or IPSS (International Prostate Symptom Score). All patients were able to urinate spontaneously within 3 days after laser ablation. Post-operative morbidities include perineal discomfort (25%), mild hematuria (17%), hematospermia (8%) and fatigue (8%), all conditions that resolve spontaneously. Perineal abrasion and transient glans paraesthesia have been reported as rare adverse events. Few patients are still undergoing laser ablation follow-up studies. Bioptic controls of the ablated region performed 3-6 months after FLA used for therapeutic purposes on selected lesions showed residual disease in 4% of treated patients (Lepor et al). In the case of residual / recurrent disease, subsequent treatments, both of focal laser ablation, and of radical therapy, such as surgery and radiotherapy, can be carried out at any time after the focal laser ablation procedure. Therefore the focal laser ablation (FLA) does not preclude a subsequent optimal therapeutic treatment.
Clinical trial: NCT04045756
Section: Purpose of Research
Subsections: Objective Of The Study

With this we intend to evaluate the short-term safety and efficacy of percutaneous ablative treatment with neodymium laser of prostate cancer, ie the complete profile of safety and tolerability in acute and in follow-up, in patients with prostate cancer intermediate risk and low risk that reject the active surveillance protocol and then surgery or radiotherapy, using the multiparametric prostate magnetic resonance as a diagnostic tool in the follow-up.
Clinical trial: NCT04045756
Section: Withdrawal from Study
Subsections: What Happens If You Decide Not To Attend The Study

You are free not to participate in the Study. In any case you will receive all the therapies provided for your condition without any penalty, and the doctors will continue to follow you anyway with due care, even if there are no other therapies available.