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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Benign Prostatic Hyperplasia; Prostate Cancer; Lower Urinary Tract Symptoms (LUTS)
• Intervention / Treatment: Procedure: Bioblation

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

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

Study Locations

• Egypt
  • Qalyubia Governorate
    • Banhā, Qalyubia Governorate, Egypt, 13518
      • Urology Department, Benha University Hospitals
      • Contact: Ahmed Mohamed Al-Ellithy, MBBCh Medical Degree; Phone Number: +201007128247; Email: ahmedallithi@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Bioblation Group; Patients with severe lower urinary tract symptoms (LUTS) and suspected low to favorable intermediate-risk prostate cancer undergoing concomitant trans-perineal prostate biopsy and laser ablation in a single session

Procedure: Bioblation; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in International Prostate Symptom Score (IPSS)	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.	Baseline, 1, 3, 6, 9, and 12 months post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Maximum Urinary Flow Rate (Q-max)	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.	Baseline, 1, 3, 6, 9, and 12 months post-procedure
Change in Post-Void Residual (PVR) Urine Volume	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.	Baseline, 1, 3, 6, 9, and 12 months post-procedure
Change in Prostate Volume	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.	Baseline, 1, 3, 6, 9, and 12 months post-procedure
Change in Total Serum Prostate-Specific Antigen (PSA)	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.	Baseline, 1, 3, 6, 9, and 12 months post-procedure
Incidence of Procedure-Related Complications	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.	Up to 12 months post-procedure

Collaborators and Investigators

• Sponsor: Benha University

Publications and helpful links

General Publications

• McVary KT. (2016) BPH: Epidemiology and pathophysiology of benign prostatic hyperplasia. Urologic Clinics of North America. 43(3):289-297. Chapple CR, et al. (2008) Lower urinary tract symptoms revisited: A broader clinical perspective. European Urology. 54(3):563-569. Foster HE, Barry MJ, Dahm P, et al. (2021) Benign Prostatic Hyperplasia: AUA Guideline. J Urol. 206(4):806-817. McConnell JD, Roehrborn CG. (2021) Benign Prostatic Hyperplasia: Diagnosis and Treatment. In: Wein AJ, Kavoussi LR, Partin AW, Peters CA, editors. Campbell-Walsh-Wein Urology, 12th ed. Elsevier. Siegel RL, Miller KD, Fuchs HE, Jemal A. (2024) Cancer Statistics. CA Cancer J Clin. 2024;74:7-33. Culp SH, Soerjomataram I, Efstathiou JA, Bray F, Jemal A. (2020) Recent Global Patterns in Prostate Cancer Incidence and Mortality Among Younger Men. Eur Urol. 77(2):125-133. Mohler JL, et al. (2025) Prostate Cancer, NCCN Guidelines Version 2.2025. J Natl Compr Canc Netw. 23:114-159. Kasivisvanathan V, et al. (2018) MRI-targeted vs Standard Biopsy for Prostate-Cancer Diagnosis. N Engl J Med. 378:1767-1777. Pacella CM, Breschi L, Bottacci D, Masotti L. (2020) Physical principles of laser ablation. In: Pacella C, Jiang T, Mauri G, editors. Image-guided laser ablation. Cham, Switzerland: Springer. Amzayyb M, van den Bos RR, Kodach VM, et al. (2010) Carbonized blood deposited on fibres during 810, 940 and 1,470 nm endovenous laser ablation: thickness and absorption by optical coherence tomography. Lasers Med Sci:25:439-47. van Riel LA, van Kollenburg RAA, Vis AN, van Leeuwen PJ, de Reijke TM, de Bruin DM et al. (2022) Safety and Feasibility of Soractelite Transperineal Focal Laser Ablation for Prostate Cancer and Short-term Quality of Life Analysis from a Multicenter Pilot Study. Eur Urol Open Sci:39:48-54. Frego N, Saita A, Casale P, Diana P, Contieri R, et al. (2021) Feasibility, safety, and efficacy of ultrasound-guided transperineal laser ablation for the treatment of benign prostatic hyperpl

Study record dates

Study Major Dates

• Study Start (Estimated): April 10, 2026
• Primary Completion (Estimated): April 20, 2026
• Study Completion (Estimated): April 28, 2026

Study Registration Dates

• First Submitted: March 27, 2026
• First Submitted That Met QC Criteria: April 9, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Prostate Cancer; Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms; Focal Therapy; Transperineal Laser Ablation; Bioblation
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Urological Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Prostatic Neoplasms; Prostatic Hyperplasia; Lower Urinary Tract Symptoms
• Other Study ID Numbers: MS.14.1.2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No