Transperineal Laser Ablation for Low- and Intermediate Risk Prostate Cancer: a Single Cohort Analysis

Transperineal Laser Ablation for Low and Intermediate Risk Prostate Cancer: a Single Cohort Analysis

The goal of this prospective study is to test the efficacy of Echolaser transperineal focal therapy in patients with low- and intermediate risk prostate cancer. The main question it aims to answer are: 1. short and intermediate term oncological outcomes after laser focal therapy, 2. functional outcomes and quality of life after treatment. Participants affected by low risk prostate cancer will undergo trans perineal laser focal therapy. Multiparametric prostate MRI will be perform after 3 and 12 months for oncological control. Re-fusion biopsy will be perform after 12 months. Functional outcomes and quality of life will be assess at 3, 6 and 12 months.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Procedure: Soractelite Echolaser Transperineal focal laser ablation

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Valerio Iacovelli, MD, PhD; Phone Number: +393398461654; Email: valerio.iacovelli85@gmail.com
• Study Contact Backup: Name: Pierluigi Bove, MD; Email: pgbove@gmail.com

Study Locations

• Italy
  • RM
    • Roma, RM, Italy, 00175
      • Recruiting
      • San Carlo di Nancy Hospital
      • Principal Investigator: Pierluigi Bove, MD
      • Sub-Investigator: Chiara Cipriani, PhD
      • Contact: Valerio Iacovelli, MD, PhD; Phone Number: +393398461654; Email: valerio.iacovelli85@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with low- and intermediate risk prostate cancer classified as International Society for Urological Pathology, ISUP 1-2.

Exclusion Criteria:

• patients diagnosed with urothelial cancer
• contraindications for MRI
• Multifocal prostate cancer

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TPLA in patients with prostate cancer; Patients diagnosed with low- and intermediate risk unifocal prostate cancer undergo to focal laser ablation therapy.	Procedure: Soractelite Echolaser Transperineal focal laser ablation; US/MRI fusion laser ablation of low- and intermediate risk prostate cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oncological outcomes MRI	Evaluation of transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by multiparametric prostate MRI. Specifically, 1. complete ablation, 2. partial ablation or 3. persistence of cancer will be identified.	3 months after treatment
Oncological outcomes MRI	Evaluation of transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by multiparametric prostate MRI. Specifically, 1. complete ablation, 2. partial ablation or 3. persistence of cancer will be identified.	12 months after treatment
Oncological outcomes PSA	Evaluation of transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by eventual reduction of PSA.	3 months after treatment.
Oncological outcomes PSA	Evaluation of transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by eventual reduction of PSA.	6 months after treatment.
Oncological outcomes PSA	Evaluation of transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by eventual reduction of PSA.	12 months after treatment.
Oncological outcomes Re-biopsy	Evaluation of histological outcomes after transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by eventual negativity for cancer in a re-biopsy.	12 months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional outcomes IPSS and IPSS QoL	Evaluation of lower urinary tract symptoms and quality of life after transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by the IPSS, International Prostatic Symptoms Score.	3, 6 and 12 months after treatment.
Quality of life Pain	Evaluation of pain after transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by the visual analogue scale (VAS). The VAS is a straight horizontal line of fixed length. The ends are defined as the extreme limits of the parameter to be measured (pain) from 0 to 10 orientated from the left (no pain) to the right (unbearable pain).	day after surgery
Functional outcomes Continence	Evaluation of continence rate after transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by the ICIQ-SF, International Consulation on Incontinence Questionnaire - Short Form.	3, 6 and 12 months after treatment.
Functional outcomes Erection	Evaluation of erectile function after transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by the IIEF5, International Index of Erectile Function.	3, 6 and 12 months after treatment.
Functional outcomes Ejaculation	Evaluation of ejaculatory function after transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by the MSHQ SF, Male Sexual Health Questionnaire short form.	3, 6 and 12 months after treatment.

Collaborators and Investigators

• Sponsor: San Carlo di Nancy Hospital
• Collaborators: Elesta S.R.L.
• Investigators: Principal Investigator: Pierluigi Bove, MD, San Carlo di Nancy Hospital

Publications and helpful links

General Publications

• van Riel LAMJG, van Kollenburg RAA, Vis AN, van Leeuwen PJ, de Reijke TM, de Bruin DM, Oddens JR. 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. 2022 Apr 2;39:48-54. doi: 10.1016/j.euros.2022.02.012. eCollection 2022 May.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Estimated): February 29, 2024
• Study Completion (Estimated): March 30, 2024

Study Registration Dates

• First Submitted: October 7, 2022
• First Submitted That Met QC Criteria: October 16, 2022
• First Posted (Actual): October 18, 2022

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: prostate cancer; TPLA; focal therapy; Echolaser; transperineal laser ablation
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: TPLA K

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The analysis of the data obtained within the trial will be subject of scientific publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No