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

NCT05163197 | Recruiting

• 1 other identifier: W21_458
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

Laser Ablation; Minimal invasive; Focal therapy

Outcome Measures

Primary Outcomes (1)

• Oncological control

  Oncological control is defined as: a PSA \<=2.0ng/mL than initial PSA and/or no residual tumor or other lesion suspicious for prostate cancer on magnetic resonance imaging and/or no gleason score upgrading on re-biopsy and/or no clinical up-staging of prostate cancer T-stage

  12 months

Secondary Outcomes (7)

• Continence rate

  12 months

• Potency rate

  12 months

• Urinary flow

  12 months

• PROM regarding voiding

  12 months

• PROM regarding erectile function

  12 months

Interventions

Transperineal Laser Ablation of Prostate Cancer PROCEDURE

Minimal invasive transperineal laser ablation treatment for prostate cancer

Also known as: Soractelite treatment, Echolaser X4

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The registry population comprises those patients that have been treated with TPLA for PCa.

You may qualify if:

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

You may not qualify if:

• Age \< 18 years

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Amsterdam University Medical Centers

Amsterdam, Netherlands

RECRUITING

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

• J. R. Oddens, MD, PhD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

L. A. van Riel, MD

CONTACT

+31 6 50 06 30 94; l.a.vanriel@amsterdamumc.nl

J. R. Oddens, MD, PhD

CONTACT

+31 6 50 06 30 94; j.r.oddens@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: December 20, 2021
• Study Start: October 1, 2021
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: December 20, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)