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

Browse trials for

• Prostatic Neoplasms 6,360
• Lower Urinary Tract Symptoms 406
• Prostatic Hyperplasia 783

Keywords

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

Study arms

• 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

Interventions

• ProcedureBioblation

  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

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-procedure

Secondary 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-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.

   Time frame: 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.

   Time frame: 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.

   Time frame: 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.

   Time frame: Up to 12 months post-procedure

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

Individual participant data

Plan to share: Undecided