Concomitant Trans-Perineal Prostate Biopsy and Ablation (Bioblation) for Prostate Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorBenha University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
IPSS score > 20
Uroflowmetry flow rate < 10 ml/sec
Post-void residual > 150 cc
PSA level between 4 and 20 ng/ml
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Bioblation
Procedure/SurgeryThe 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Bioblation GroupExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Baseline, 1, 3, 6, 9, and 12 months post-procedureSecondary outcomes
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.
Time frame
Baseline, 1, 3, 6, 9, and 12 months post-procedure2
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.
Time frame
Baseline, 1, 3, 6, 9, and 12 months post-procedure3
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.
Time frame
Baseline, 1, 3, 6, 9, and 12 months post-procedure4
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.
Time frame
Baseline, 1, 3, 6, 9, and 12 months post-procedureSponsors and contacts
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Source ClinicalTrials.gov