Prostate Cancer Clinical Trial
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
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.
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).
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