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Concomitant Trans-Perineal Prostate Biopsy and Ablation (Bioblation) for Prostate Cancer

Sponsor: Benha University • ClinicalTrials.gov ID: NCT07526675

Registry updated: 2026-09-30

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Description

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

Bioblation (Procedure)
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.

Eligibility criteria

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

Conditions

Prostate Cancer Lower Urinary Tract Symptoms (LUTS) Benign Prostatic Hyperplasia

Locations

Urology Department, Benha University Hospitals — Banhā, Qalyubia Governorate, Egypt

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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