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

RecruitingNAAges 18 Months - anyMaleBenha University
NCT07526675 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Bioblation
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Where

1 site
Urology Department, Benha University Hospitals
Banhฤ, Egypt
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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