Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms (LUTS), Prostate Cancer
Conditions
Keywords
Prostate Cancer, Transperineal Laser Ablation, Bioblation, Focal Therapy, Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia
Brief summary
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.
Interventions
PROCEDUREBioblation
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.
Sponsors
Benha University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Months to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with severe Lower Urinary Tract Symptoms (LUTS) meeting the following parameters: 1. IPSS score \> 20 2. Uroflowmetry flow rate \< 10 ml/sec 3. Post-void residual \> 150 cc * Patients most probably having low to favorable intermediate-risk prostate cancer, defined as: 1. PSA level between 4 and 20 ng/ml 2. MP-MRI showing 3 or fewer focal lesions 3. MP-MRI focal lesions measuring \< 1.5 cm * International or visiting patients requiring early return to their home country due to professional or personal commitments, provided they can undergo short-term management and follow-up coordination
Exclusion criteria
* Patient PSA level \> 20 ng/ml * More than 3 focal lesions on MP-MRI * Metastatic prostate cancer * History of lower urinary tract surgery (e.g., TURP, Laser, urinary diversions, artificial urinary sphincter) * History of pelvic radiation therapy or radical pelvic surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in International Prostate Symptom Score (IPSS) | Baseline, 1, 3, 6, 9, and 12 months post-procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Maximum Urinary Flow Rate (Q-max) | Baseline, 1, 3, 6, 9, and 12 months post-procedure | 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. |
| Change in Post-Void Residual (PVR) Urine Volume | Baseline, 1, 3, 6, 9, and 12 months post-procedure | 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. |
| Change in Prostate Volume | Baseline, 1, 3, 6, 9, and 12 months post-procedure | 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. |
| Change in Total Serum Prostate-Specific Antigen (PSA) | Baseline, 1, 3, 6, 9, and 12 months post-procedure | 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. |
| Incidence of Procedure-Related Complications | Up to 12 months post-procedure | 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. |
Countries
Egypt
Contacts
CONTACTAhmed Mohamed AL-Lithi, MBBCh Medical Degree
Outcome results
None listed