Bioblation: Combined biopsy and laser treatment for prostate symptoms and suspected cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective study tests whether performing a trans-perineal biopsy and targeted laser ablation in one session under local anesthesia is safe and effective for men with severe LUTS and suspected early‑stage prostate cancer. Eligible participants have high symptom scores, reduced urine flow, large residual urine, and MRI findings suggesting a small number of focal cancer lesions. The trial aims to see if this combined approach provides symptom relief and rapid return to activities without compromising cancer control, compared with standard sequential procedures. Outcomes focus on safety, symptom improvement, urinary function, and oncologic efficacy. Patients will be followed to monitor adverse events and treatment success over time.

Why it matters

Who can join: the full rules

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

Where it's running

• Urology Department, Benha University Hospitals
  Banhā, Qalyubia Governorate, Egypt Recruiting

Study contacts

• Study coordinator: Ahmed Mohamed AL-Lithi, MBBCh Medical Degree
• Email: ahmedallithi@gmail.com
• Phone: +201007128247

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.