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

NCT ID: NCT05584787

Last Updated: 2024-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2024-03-30

Brief Summary

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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

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TPLA in patients with prostate cancer

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

Group Type EXPERIMENTAL

Soractelite Echolaser Transperineal focal laser ablation

Intervention Type PROCEDURE

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

Interventions

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Soractelite Echolaser Transperineal focal laser ablation

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Elesta S.R.L.

INDUSTRY

Sponsor Role collaborator

San Carlo di Nancy Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierluigi Bove, MD

Role: PRINCIPAL_INVESTIGATOR

San Carlo di Nancy Hospital

Locations

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San Carlo di Nancy Hospital

Roma, RM, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Valerio Iacovelli, MD, PhD

Role: CONTACT

+393398461654

Pierluigi Bove, MD

Role: CONTACT

Facility Contacts

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Valerio Iacovelli, MD, PhD

Role: primary

+393398461654

References

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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.

Reference Type RESULT
PMID: 35528781 (View on PubMed)

Other Identifiers

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TPLA K

Identifier Type: -

Identifier Source: org_study_id

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