Clinical trial NCT04045756: Focal Laser Ablation for the Treatment of Focal Low-Intermediate Risk Prostate Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Keywords: prostate cancer
laser ablation
mpMRI
interventional radiology
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
First posted: 2019-08-06
Enrollment: 50
Sex: MALE
Minimum age (years): 46
Maximum age (years): 86
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Short-term Efficacy of Transperineal Laser Ablation (TPLA) with Image Fusion and Multi-parametric (mpMRI) Follow-up in Focal Low-intermediate Risk Prostate Cancer. It is an interventional pilot study. The clinical evaluation will be carried out at different times as follows:

Time 0: recruitment and eligibility assessment (patient selection) Time 1: interview, signing of informed consent and enrollment Time 2: FLA treatment and control with multiparametric MRI of the post-procedural prostate.

Time 3-4-5-6: follow up to 1 (T3), 6 (T4), 12 (T5) and 24 (T6) months from the procedure.

The primary objective of the study is to evaluate the short-term (2 years) efficacy of FLA treatment of low-intermediate risk prostate cancer Secondary objective is to investigate multiparametric prostate MRI as a follow-up diagnostic investigation, evaluating possible glandular morphostructural changes and their correlation with clinical data.

Detailed description: Short-term Efficacy of Transperineal Laser Ablation (TPLA) With Image Fusion and Multi-parametric (mpMRI) Follow-up in Focal Low-intermediate Risk Prostate Cancer. It is an interventional pilot study.

The recruitment and evaluation of eligibility will be done by the Multidisciplinary Neoplasms Group of the Uro-Genital System, already operating within the Tor Vergata Polyclinic Foundation and formed by the following Operating Units:

UOSD Urology, UOC Diagnostic Imaging, UOC Medical Oncology, UOC Radiotherapy, UOSD Pathological Anatomy, UOC Nuclear Medicine. The Multidisciplinary Group will propose and evaluate patients that can be recruited based on inclusion and exclusion criteria. The patient considered eligible for the study will be adequately informed by the UOSD Urology / UOC Diagnostic Imaging regarding the therapeutic possibilities for the specific disease stage.

If the patient expresses an interest in participating in the study, he will be given informed consent.

Once the informed consent has been signed, the patient will be considered enrolled in the study.

Pre-procedural evaluation

Pre-treatment clinical-instrumental-blood chemistry tests include:

* Electrocardiogram
* Complete blood count, blood ureanitrogen (BUN), creatinine, sodium, potassium, coagulation tests
* Urine examination and urine culture
* Evaluation of the post-voiding residue
* Uroflowmetry (if IPSS\> 7)

Questionnaires:

* IPSS-QoL
* IIEF

Focal laser ablation treatment (FLA):

The treatments will be performed by the Diagnostic Imaging team, on a Day Hospital basis, using the combined Echolaser XVG system (Elesta s.r.l - Calenzano (FI)).

The EchoLaser Therapy is a micro-invasive percutaneous procedure that uses the laser light transmitted through applicators (optical fibers) for a few minutes, causing the affected tissue to warm up until it is irreversibly damaged in "situ", without the need to remove it.

All this thanks to the combined action of an increase in the local temperature and the exposure time. The interaction of laser radiation with a wavelength of 1064nm (in the range of the therapeutic window) is excellent, with low radiation absorption and excellent light penetration. The laser light is conveyed from the source to the fabric through extremely flexible, small-caliber (300 micron diameter) flat-tip quartz optical fibers, introduced percutaneously by thin needles (21 Gauge).

The EchoLaser Therapy, through flat-tipped fibers, produces an ellipsoidal coagulation area (an area where the tissue has irreversible damage). A possible multi-fiber approach can extend the coagulation area.

The EchoLaser Therapy can be performed under ultrasound guidance for real-time monitoring of the correct positioning of the laser light applicators and the effective extension of the damage to the tumor lesion.

The procedure will be performed with a patient in a lithotomy position and in safe conditions according to the current legislation for treatments with laser systems (such as protective glasses).

Treatment includes local anesthesia of the perineal region, under ultrasound guidance. At the discretion of the medical team, intravenous sedation can be performed.

1-2 spinal needles 21G will be inserted into the intralesional site by ultrasound-guided transperineal route after MRI / TRUS image fusion. In each needle a 300 micron optical fiber will be inserted (Elesta s.r.l., Calenzano (FI)). For each lighting, for about 6 minutes, a maximum energy of 1800 J per fiber will be delivered, with a power of 2-5 Watts. If necessary, the needle and fiber will be retracted for about 1 cm ("pull-back"). Further lighting will follow, with delivery and duration and power equal to the previous one.

Immediately after the procedure, the patient will be asked to complete the VAS score for the assessment of pain felt during the procedure.

Complications: The potential complications of the FLA technique are:

* Peri-operative: perineal and hypogastric pain, perineal hematoma, hematuria, acute urinary retention, fever, dysuria
* Postoperative: perineal pain, LUTS, persistent hematuria, hematospermia, erectile dysfunction, urinary incontinence Complications will be investigated prospectively using the Clavien-Dindo classification

Follow-up: The clinical evaluation will be carried out at different times:

Post procedural follow up A multi-parametric prostate MRI will be performed immediately after the treatment. At the end of the treatment the resumption of spontaneous diuresis will be checked and in the case of acute urinary retention / clinically significant hematuria a bladder catheter will be inserted.

An oral cortisone drug (Deflazacort 30 mg) or other anti-edema therapy will be prescribed if specifically contraindicated by the patient.

Any complications will be recorded according to the Clavien-Dindo classification The patient will be discharged with antibiotic therapy, pain relief when needed and gastroprotective for 5-7 days.

Patients will receive a telephone contact to use to communicate any post-operative emergencies.

Post-discharge follow-up The specialist follow-up visit to 1 (T3), 6 (T4), 12 (T5) and 24 (T6) months from the procedure will be conducted by the UOSD Urology.

Any reported complications will be recorded according to the Clavien-Dindo classification.

The patient will be asked to complete the IPSS-QoL and IIEF questionnaires and will view the total serum PSA (T4-T5-T6).

Multi-parametric prostate MRI will be performed at T4-T6. Transperineal prostatic control biopsy will be performed with fusion target (ablated zone) and systematic technique (T4-T6).

Eligibility criteria: Inclusion Criteria:

* Male
* Over 45 years old
* Prostate cancer identified after prostatic biopsy with fusion of images with target and systematic samples (\> 12)
* Intermediate progression risk (Gleason Score 3 + 4 or 4 + 3; PSA \<15 ng / ml; clinical stage T1-T2a)
* Low risk of progression (Gleason score 3 + 3) only in patients who wish to leave or who refuse the active surveillance protocol and who refuse validated treatments for the treatment of organo-confined prostate cancer: radical surgery and / or radiotherapy

Exclusion Criteria:

* Prostate cancer Gleason Score\> = 4 + 4.
* Clinical stage\> T2a
* PSA\> 15 ng / ml
* Presence of metastases from prostate lymph node, bone or visceral carcinoma detected by bone scintigraphy, total body CT or PET-CT
* Serious coagulation disorders not correctable
* Unavailable or replaceable anticoagulant and / or antiplatelet therapy
* Inadequate compliance
* Presence of pacemakers
* Contraindications to MRI (claustrophobia, ear implants, metal prostheses)
* Paramagnetic contrast agent allergy
* Acute and / or chronic renal failure (GFR \<50 mL / min and serum creatinine\> 1.5 mg / dl)
* Tumor volume \<15 ml measured on MRI

Primary outcomes:
measure: Disease free survival
timeFrame: 5 years
measure: Evaluation of Complications of prostate Laser Ablation on the Treatment of Focal Low-Intermediate Risk Prostate Cancer by use of mp-MRI.
timeFrame: 5 years
Secondary outcomes:
measure: Reproducibility of mpMRI in correlation with biopsy in order to establish positive/negative predictive diagnostic values of MRI in residual/relapsing tumors
timeFrame: 5 years
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Policlinico Tor Vergata (PTV) Foundation: Department di Biomedicine and Prevention
state: RM
Study officials:
affiliation: Fondazione Policlinico Tor Vergata
name: Guglielmo Manenti, MD PhD
role: PRINCIPAL_INVESTIGATOR
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