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

NCT07526675 | Not Yet Recruiting

• 1 other identifier: MS.14.1.2026
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Prostate Cancer; Transperineal Laser Ablation; Bioblation; Focal Therapy; Lower Urinary Tract Symptoms; Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in Maximum Urinary Flow Rate (Q-max)

  Baseline, 1, 3, 6, 9, and 12 months post-procedure

• Change in Post-Void Residual (PVR) Urine Volume

  Baseline, 1, 3, 6, 9, and 12 months post-procedure

• Change in Prostate Volume

  Baseline, 1, 3, 6, 9, and 12 months post-procedure

• Change in Total Serum Prostate-Specific Antigen (PSA)

  Baseline, 1, 3, 6, 9, and 12 months post-procedure

• Incidence of Procedure-Related Complications

  Up to 12 months post-procedure

Study Arms (1)

Bioblation Group

EXPERIMENTAL

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

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.

Also known as: Elesta laser system

Bioblation Group

Eligibility Criteria

• Age: 18 Months+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Urology Department, Benha University Hospitals

Banhā, Qalyubia Governorate, 13518, Egypt

Location

Related Publications (1)

• 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

  BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms; Lower Urinary Tract Symptoms; Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ahmed Mohamed AL-Lithi, MBBCh Medical Degree

CONTACT

+201007128247; ahmedallithi@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 13, 2026
• Study Start: April 10, 2026
• Primary Completion: April 20, 2026
• Study Completion: April 28, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

EG (1)