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Not yet recruiting NCT07526675

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

No phase Interventional Prostate Cancer Lower Urinary Tract Symptoms (LUTS) Benign Prostatic Hyperplasia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bioblation.
Who it may be relevant to
Registry conditions: Prostate Cancer, Lower Urinary Tract Symptoms (LUTS), Benign Prostatic Hyperplasia. Basic parameters: from 18 months · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Change in International Prostate Symptom Score (IPSS) [Time frame: Baseline, 1, 3, 6, 9, and 12 months post-procedure]
Secondary outcome measures (5)
  • Change in Maximum Urinary Flow Rate (Q-max) [Time frame: Baseline, 1, 3, 6, 9, and 12 months post-procedure]
  • Change in Post-Void Residual (PVR) Urine Volume [Time frame: Baseline, 1, 3, 6, 9, and 12 months post-procedure]
  • Change in Prostate Volume [Time frame: Baseline, 1, 3, 6, 9, and 12 months post-procedure]
  • Change in Total Serum Prostate-Specific Antigen (PSA) [Time frame: Baseline, 1, 3, 6, 9, and 12 months post-procedure]
  • Incidence of Procedure-Related Complications [Time frame: Up to 12 months post-procedure]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Urology Department, Benha University Hospitals — Banhā

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, Roeh

Identifiers

NCT: NCT07526675 · MS.14.1.2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗