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Prostate CancerTPLAforPCaNCT05163197

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

An observational study of Prostate Cancer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Transperineal Laser Ablation of Prostate Cancer
Type of treatment
Surgery or procedure
How many people
200 participants
Where
1 siteNetherlands
Study dates
1 Oct 2021to 1 Oct 2027
How long will I take part?
5 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • Age < 18 years

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

Netherlands1 site, 1 recruiting

  • Amsterdam University Medical Centers

    Amsterdam

    L. A. van Riel, MD, +31 6 50 06 30 94, l.a.vanriel@amsterdamumc.nl

    Recruiting

Other trials in Netherlands

About this study

Official title: Transperineal Laser Ablation Treatment for Prostate Cancer Registry: a Retrospective and Multicenter Evaluation

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.

Read more

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
Being tested
Transperineal Laser Ablation of Prostate Cancer
Keywords
Laser Ablation, Minimal invasive, Focal therapy
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transperineal Laser Ablation of Prostate CancerProcedure or surgery

    Also called Soractelite treatment, Echolaser X4

    Minimal invasive transperineal laser ablation treatment for prostate cancer

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 months

Secondary outcomes (7)

  1. Continence rate

    Continence is assessed by usage of number of pads per day, and 0-1 pad per day usage is defined as continent.

    Measured: 12 months

  2. Potency rate

    Potency is defined as erectile function sufficient for sexual intercourse, with or without medical aid

    Measured: 12 months

  3. Urinary flow

    Urinary flow is assessed by peak urinary flow (mL/s) and residual urine (mL). The higher the peak urinary flow and the lower the residual urine, the better the urinary flow.

    Measured: 12 months

  4. PROM regarding voiding

    International Prostate Symptom Score (IPSS) is used to determine functional outcome regarding voiding. IPSS is on a score of 0 to 35, and the higher the score the worse the outcome.

    Measured: 12 months

  5. PROM regarding erectile function

    International Index of Erectile Function (IIEF-5) is used to determine erectile function based on a validated questionnaire. IIEF-5 is on a scale of 5 to 25, and the higher the score the better the outcome.

    Measured: 12 months

  6. Safety of TPLA for PCa

    Safety is defined as 10% or less CTCAE (version 5) grade 3 and no CTCAE grade 4 or 5

    Measured: Up to 12 weeks

  7. Feasibility of TPLA for PCa

    Feasibility is assessed by amount of machine failures perioperatively of TPLA and hospital duration (hours) directly after TPLA.

    Measured: Up to 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2021
  2. Study start1 Oct 2021
  3. Primary completion1 Oct 2026 (estimated)
  4. Study completion1 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT05163197
Sponsor's protocol ID
W21_458
Acronym
TPLAforPCa
Status last verified
Dec 2021
First submitted
28 Oct 2021
Last updated
20 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • de Bie KCC, Cornud FC, Walser EM, van Riel LAMJG, Regusci S, Martins Favre M, Zimmer RE, Galiano M, Manenti G, Micillo A, Oddens JR. One-year Follow-up after US-guided Transperineal Focal Laser Ablation of Localized Prostate Cancer: Worldwide Registry Study. Radiology. 2026 Jun;319(3):e251658. doi: 10.1148/radiol.251658.

    PubMed 42227864

  • Cornud F, de Bie K, van Riel L, Lefevre A, Camparo P, Galiano M. MRI-directed Micro-US-guided Transperineal Focal Laser Ablation for Localized Prostate Cancer: A 1-year Follow-up Study. Radiology. 2024 Dec;313(3):e233371. doi: 10.1148/radiol.233371.

    PubMed 39718499

Questions about this trial

What is this clinical trial studying?

An observational study of Prostate Cancer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact L. A. van Riel, MD (+31 6 50 06 30 94, l.a.vanriel@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oncological control (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05163197, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2021.

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