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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05584787
• Other study ID #: TPLA K
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: March 30, 2024

Study information

• Verified date: January 2024
• Source: San Carlo di Nancy Hospital
• Contact: Valerio Iacovelli, MD, PhD
• Phone: +393398461654
• Email: valerio.iacovelli85[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 30, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• Soractelite Echolaser Transperineal focal laser ablation
US/MRI fusion laser ablation of low- and intermediate risk prostate cancer

Locations

Country	Name	City	State
Italy	San Carlo di Nancy Hospital	Roma	RM

Sponsors (2)

Lead Sponsor	Collaborator
San Carlo di Nancy Hospital	Elesta S.R.L.

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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.