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

Not Applicable

Recruiting

• Conditions: Prostate Cancer
• Interventions: Procedure: Soractelite Echolaser Transperineal focal laser ablation

• Registration Number: NCT05584787
• Lead Sponsor: San Carlo di Nancy Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-01
• Study First Submitted: 2022-10-07
• Study First Submitted QC: 2022-10-16
• Study First Posted: 2022-10-18
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-09
• Last Update Posted: 2024-01-10
• Primary Completion: 2024-02-29
• Study Completion: 2024-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TPLA in patients with prostate cancer	Soractelite Echolaser Transperineal focal laser ablation	Patients diagnosed with low- and intermediate risk unifocal prostate cancer undergo to focal laser ablation therapy.

Primary Outcome Measures

Name	Time	Method
Oncological outcomes PSA	12 months after treatment.	Evaluation of transperineal laser focal therapy on unifocal low- and intermediate risk prostate cancer as assessed by eventual reduction of PSA.
Oncological outcomes Re-biopsy	12 months after treatment	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.
Oncological outcomes MRI	12 months after treatment	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.

Secondary Outcome Measures

Name	Time	Method
Quality of life Pain	day after surgery	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).
Functional outcomes Erection	3, 6 and 12 months after treatment.	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.
Functional outcomes IPSS and IPSS QoL	3, 6 and 12 months after treatment.	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.
Functional outcomes Continence	3, 6 and 12 months after treatment.	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.
Functional outcomes Ejaculation	3, 6 and 12 months after treatment.	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.

Trial Locations

Locations (1)

San Carlo di Nancy Hospital; 🇮🇹 Roma, RM, Italy