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

NCT05584787 | Unknown DMC

• 1 other identifier: TPLA K
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

prostate cancer; focal therapy; Echolaser; transperineal laser ablation; TPLA

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (5)

• Functional outcomes IPSS and IPSS QoL

  3, 6 and 12 months after treatment.

• Quality of life Pain

  day after surgery

• Functional outcomes Continence

  3, 6 and 12 months after treatment.

• Functional outcomes Erection

  3, 6 and 12 months after treatment.

• Functional outcomes Ejaculation

  3, 6 and 12 months after treatment.

Study Arms (1)

TPLA in patients with prostate cancer

EXPERIMENTAL

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

Procedure: Soractelite Echolaser Transperineal focal laser ablation

Interventions

Soractelite Echolaser Transperineal focal laser ablation PROCEDURE

US/MRI fusion laser ablation of low- and intermediate risk prostate cancer

TPLA in patients with prostate cancer

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: The trial is conducted on a population of males who underwent surgical intervention for prostate cancer.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• San Carlo di Nancy Hospital: lead
• Elesta S.R.L.: collaborator

Study Sites (1)

San Carlo di Nancy Hospital

Roma, RM, 00175, Italy

RECRUITING

Related 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 Study. Eur Urol Open Sci. 2022 Apr 2;39:48-54. doi: 10.1016/j.euros.2022.02.012. eCollection 2022 May.

  PMID: 35528781 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Pierluigi Bove, MD

  San Carlo di Nancy Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valerio Iacovelli, MD, PhD

CONTACT

+393398461654; valerio.iacovelli85@gmail.com

Pierluigi Bove, MD

CONTACT

pgbove@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2022
• First Posted: October 18, 2022
• Study Start: May 1, 2021
• Primary Completion: February 29, 2024
• Study Completion: March 30, 2024
• Last Updated: January 10, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)