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

San Carlo di Nancy Hospital

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Procedure: Soractelite Echolaser Transperineal focal laser ablation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05584787

TPLA K

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: Male

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

TPLA in patients with prostate cancer

Experimental group

Description:

Patients diagnosed with low- and intermediate risk unifocal prostate cancer undergo to focal laser ablation therapy.

Treatment:

Procedure: Soractelite Echolaser Transperineal focal laser ablation