Clinical trial · Interventional
Concomitant Trans-Perineal Prostate Biopsy and Ablation (Bioblation) for Prostate Cancer
Validation of Concomitant Trans-Perineal Prostate Biopsy and Ablation (Bioblation) for Symptomatic (LUTS) Selected Most Probably Low and Intermediate Risk PCa Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Benign Prostatic Hyperplasia | Benign Prostatic Hyperplasia | ONTOLOGY_EXACT | 0.98 |
| Lower Urinary Tract Symptoms (LUTS) | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bioblation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bioblation Group
- description
- 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
- interventionNames
- Procedure: Bioblation
Primary outcomes (1)
- measure
- Change in International Prostate Symptom Score (IPSS)
- timeFrame
- Baseline, 1, 3, 6, 9, and 12 months post-procedure
- description
- 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.
Secondary outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Months
Show eligibility criteria text
Inclusion Criteria: * Patients with severe Lower Urinary Tract Symptoms (LUTS) meeting the following parameters: 1. IPSS score \> 20 2. Uroflowmetry flow rate \< 10 ml/sec 3. Post-void residual \> 150 cc * Patients most probably having low to favorable intermediate-risk prostate cancer, defined as: 1. PSA level between 4 and 20 ng/ml 2. MP-MRI showing 3 or fewer focal lesions 3. 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
References
Publications (1)
- BACKGROUNDMcVary 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