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Transperineal Laser Ablation Treatment (TPLA) for Prostate Cancer (PCa) Registry

NCT ID: NCT05163197

Last Updated: 2021-12-20

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

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-01

Study Completion Date

2027-10-01

Brief Summary

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Rationale: Transperineal laser ablation (TPLA) treatment for prostate cancer (PCa) is a minimal invasive focal therapy technique studied worldwide to determine its efficacy. In pilot studies it has shown to be a safe and feasible technique and it has potential to preserve continence and potency over current standard radical therapies. However, (long-term) treatment outcomes of TPLA for PCa remain largely unknown. The aim of this international retrospective registry is to collect and combine data on patients treated TPLA for PCa in order to provide data on safety, feasibility, functional and oncological outcomes.

Objective: To assess safety and feasibility of TPLA for PCa, to assess functional and oncological outcomes of TPLA for PCa and to determine baseline patient characteristics in a multicentre cohort.

Study design: This is an international, retrospective observational registry in which data is recorded of patients who have been treated with TPLA for PCa.

Study population: Male patients treated with TPLA for PCa. Main study parameters/endpoints: The primary endpoint of this registry is oncological outcomes of TPLA for PCa. Secondary endpoints are safety, feasibility and functional outcomes of TPLA for PCa.

Detailed Description

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Conditions

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Prostate Cancer

Keywords

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Laser Ablation Minimal invasive Focal therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Transperineal Laser Ablation of Prostate Cancer

Minimal invasive transperineal laser ablation treatment for prostate cancer

Intervention Type PROCEDURE

Other Intervention Names

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Soractelite treatment Echolaser X4

Eligibility Criteria

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Inclusion Criteria

* Male, histological-confirmed disease of localized prostate cancer, TPLA treatment for PCa is performed

Exclusion Criteria

* Age \< 18 years
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role lead

Responsible Party

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Prof.dr. H.P. Beerlage

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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J. R. Oddens, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

Locations

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Amsterdam University Medical Centers

Amsterdam, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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L. A. van Riel, MD

Role: CONTACT

Phone: +31 6 50 06 30 94

Email: [email protected]

J. R. Oddens, MD, PhD

Role: CONTACT

Phone: +31 6 50 06 30 94

Email: [email protected]

Facility Contacts

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L. A. van Riel, MD

Role: primary

Other Identifiers

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W21_458

Identifier Type: -

Identifier Source: org_study_id