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NCT Number: NCT07526675

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

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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Key information

Conditions

Prostate Cancer Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Lower Urinary Tract Symptoms Lower Urinary Tract Symptoms (LUTS) Male Urogenital Diseases Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Hyperplasia Prostatic Neoplasms Signs and Symptoms Urogenital Diseases Urogenital Neoplasms Urological Manifestations

Age range

18 month and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Urology Department, Benha University Hospitals

Banhā, Qalyubia Governorate, 13518, Egypt

Location contact

Ahmed Mohamed Al-Ellithy, MBBCh Medical Degree

CONTACT

[email protected]

+201007128247

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with severe Lower Urinary Tract Symptoms (LUTS) meeting the following parameters:
  • IPSS score > 20
  • Uroflowmetry flow rate < 10 ml/sec
  • Post-void residual > 150 cc
  • Patients most probably having low to favorable intermediate-risk prostate cancer, defined as:
  • PSA level between 4 and 20 ng/ml
  • MP-MRI showing 3 or fewer focal lesions
  • 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

Treatment and study plan

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.

Other names: Elesta laser system

Primary outcomes

  1. Change in International Prostate Symptom Score (IPSS)

    Time frame: 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 outcomes

  1. Change in Maximum Urinary Flow Rate (Q-max)

    Time frame: 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.

  2. Change in Post-Void Residual (PVR) Urine Volume

    Time frame: 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.

  3. Change in Prostate Volume

    Time frame: 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.

  4. Change in Total Serum Prostate-Specific Antigen (PSA)

    Time frame: 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.

  5. Incidence of Procedure-Related Complications

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Mohamed AL-Lithi, MBBCh Medical Degree

CONTACT

[email protected]

+201007128247

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

Validation of Concomitant Trans-Perineal Prostate Biopsy and Ablation (Bioblation) for Symptomatic (LUTS) Selected Most Probably Low and Intermediate Risk PCa Patients

Acronym: Bioblation

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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