This prospective study aims to validate the clinical outcomes of performing a concomitant trans-perineal prostate biopsy and laser ablation (termed "Bioblation") during a single session. The intervention is designed for symptomatic patients presenting with lower urinary tract symptoms (LUTS) who are highly suspected to have low to favorable intermediate-risk prostate cancer. By combining diagnosis and targeted treatment under local anesthesia, this approach seeks to facilitate early relief of severe symptoms and a rapid return to daily activities. Ultimately, the study evaluates whether this combined procedure decreases the patient's exposure to multiple, temporally separated interventions without compromising oncological safety or efficacy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
The procedure is performed under local anesthesia and a prostatic nerve block. Under real-time transrectal ultrasound (TRUS) visualization, four biopsy cores are taken transperineally from each suspected focal lesion, alongside systematic biopsies of the transitional zones. Immediately following the biopsy, 18G Chipa needles are inserted transperineally to pass 300-micron laser fibers to the target site. Using the Elesta system, 7W of laser energy is delivered via MRI-guided cognitive fusion to induce thermal coagulative necrosis of the tumor.
Urology Department, Benha University Hospitals
Banhā, Qalyubia Governorate, Egypt
Change in International Prostate Symptom Score (IPSS)
The IPSS is a validated questionnaire used to assess the severity of lower urinary tract symptoms (LUTS). The total score ranges from 0 to 35, where 0-7 indicates mildly symptomatic, 8-19 moderately symptomatic, and 20-35 severely symptomatic. A decrease in the score indicates an improvement in symptoms.
Time frame: Baseline, 1, 3, 6, 9, and 12 months post-procedure
Change in Maximum Urinary Flow Rate (Q-max)
Maximum urinary flow rate will be measured using uroflowmetry to assess functional improvement in urination. It is measured in milliliters per second (mL/sec). A higher value indicates better urinary flow and less obstruction.
Time frame: Baseline, 1, 3, 6, 9, and 12 months post-procedure
Change in Post-Void Residual (PVR) Urine Volume
PVR will be measured via ultrasound to determine the volume of urine remaining in the bladder immediately after urination. It is measured in milliliters (mL) or cubic centimeters (cc). A lower volume indicates better bladder emptying.
Time frame: Baseline, 1, 3, 6, 9, and 12 months post-procedure
Change in Prostate Volume
Total prostate gland volume will be assessed using transrectal ultrasound (TRUS) or multiparametric MRI. It is measured in cubic centimeters (cc) or milliliters (mL). A decrease in volume indicates a reduction in gland size following the ablation procedure.
Time frame: Baseline, 1, 3, 6, 9, and 12 months post-procedure
Change in Total Serum Prostate-Specific Antigen (PSA)
Measurement of total serum PSA levels (in ng/mL) to monitor oncological control, disease status, and therapeutic response following the focal ablation of the suspected prostate lesions.
Time frame: Baseline, 1, 3, 6, 9, and 12 months post-procedure
Incidence of Procedure-Related Complications
The occurrence, type, and severity of post-operative adverse events (such as hematuria, acute urinary retention, fever, or signs of infection) will be recorded to evaluate the safety profile of the concomitant biopsy and ablation procedure.
Time frame: Up to 12 months post-procedure
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