AzTrials
AzTrials

Prostate CancerBioblationNCT07526675

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

A study testing Bioblation in people with Prostate Cancer and Lower Urinary Tract Symptoms (LUTS), run by Benha University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 months and older, men only
What is being tested?
Bioblation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteEgypt
Study dates
10 Apr 2026to 28 Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 months and older
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ahmed Mohamed AL-Lithi, MBBCh Medical Degree contact

+201007128247

ahmedallithi@gmail.com

Egypt1 site, 1 recruiting

  • Urology Department, Benha University Hospitals

    Banhā, Qalyubia Governorate, 13518

    Ahmed Mohamed Al-Ellithy, MBBCh Medical Degree, +201007128247, ahmedallithi@gmail.com

    Recruiting

Other trials in Egypt

About this study

Official title: 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.

Being tested
Bioblation
Keywords
Prostate Cancer, Transperineal Laser Ablation, Bioblation, Focal Therapy, Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia
Medical subject headings
Prostatic Neoplasms, Lower Urinary Tract Symptoms, Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BioblationProcedure or surgery

    Also called Elesta laser system

    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.

Study groups in NCT07526675
Study groupRoleWhat they receive
Bioblation GroupExperimentalPatients 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
Receives: Procedure: Bioblation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (5)

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

    Measured: Up to 12 months post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2026
  2. Study start10 Apr 2026
  3. Primary completion20 Apr 2027 (estimated)
  4. Study completion28 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07526675
Sponsor's protocol ID
MS.14.1.2026
Acronym
Bioblation
Status last verified
Apr 2026
First submitted
27 Mar 2026
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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

Questions about this trial

What is this clinical trial studying?

A study testing Bioblation in people with Prostate Cancer and Lower Urinary Tract Symptoms (LUTS), run by Benha University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ahmed Mohamed AL-Lithi, MBBCh Medical Degree (+201007128247, ahmedallithi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in International Prostate Symptom Score (IPSS) (time frame: Baseline, 1, 3, 6, 9, and 12 months post-procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07526675, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in